Committee on Energy and Commerce

Fred Upton

Weekly Republican Address: With 21st Century Cures, We Will Do Better

2016/12/10

[[{"fid":"1973","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"238","width":"423","class":"media-element file-full"}}]] Watch Chairman Upton’s address HERE. WASHINGTON, DC – In this week’s Republican address, House Energy and Commerce Committee Chairman Fred Upton (R-MI) discusses #CuresNow—legislation signed by Speaker Ryan this week to bring medical research and innovation into the 21st century. “The House and Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology,” said Chairman Upton. He continued, “A new day for medical research is on the horizon. A new day of hope for patients and their loved ones. We needed to do better. And with 21st Century Cures, we will.”

 Remarks of Energy and Commerce Committee Chairman Fred Upton of Michigan
 Weekly Republican Address
 Washington, DC
 December 10, 2016 Hey there, I’m Fred Upton, Republican Congressman from Southwest Michigan who helped lead the successful, bipartisan effort to find faster cures for families and patients suffering from tragic illness. The holiday season is one of joy. But, it’s often a time for families to come together and reflect on loved ones lost—taken much too soon by disease. We’ve all said too many early good-byes to folks that we hold dear. Families robbed of a parent that will never get to see their kids’ milestones. A child born without the gift of a future. Every day, countless folks living vibrant lives are delivered unexpected diagnoses. It’s a cycle that repeats itself over and over and over. Life changes in an instant—and hope seems just out of reach. Whether it be Alzheimer’s, Lupus, MS, cancer… you name it. So, three years ago, we had an idea. That we could do better. That we needed to do something and transform our health and research system to effectively fight disease in the 21st century. But we knew the first step had to be doing something that Congress doesn’t do enough of: We had to first listen. And then we engaged. We solicited input. We drafted. We listened some more. It was an inclusive, unique, transparent process that criss-crossed the country, engaging experts in every related field, from pioneering research institutions like the University of Michigan and the Mayo Clinic to government to private industry and everything in between. And most importantly, we listened to patients. What we learned was staggering. The gap between biomedical innovation and our regulatory process was widening. Of the 10,000 known diseases—7,000 of which are rare—there are treatments for only 500. We needed to change the conversation and restore urgency to boosting research and innovation. And working together, we have with 21st Century Cures. Science and biomedical innovation have made incredible strides over the last two decades. Mapping the human genome, new biomarkers, and personal health care apps have all offered opportunities to find new treatments and cures. But the way the FDA and the NIH apply these new innovations to our regulatory process has lagged behind. These agencies—and the rules and regs that they produce affecting the discovery, development, and delivery of lifesaving drugs and devices—also desperately need modernization and innovation. They need a game-changer. And now we have it. The House and Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology. We break down regulatory barriers and expedite the approvals for safe drugs and devices coupled with billions for more research, including the Beau Biden Cancer Moonshot. We also provide critical funding to the FDA so that they have all the tools they need to ensure the safety of these news drugs and devices. A former head of The National Cancer Institute and FDA has called this “the most transformational biomedical legislation in the past 40 years.” He’s right. But this package is not just about cures. It also includes valuable resources to fight the opioid epidemic that’s impacting every single community, and delivers landmark mental health reforms that will make a real difference, helping families in crisis and treating mental illness rather than incarceration. Treatment, not tragedy was the overriding theme of mental health reform. Yes, this is one of the most important and impactful bills we will enact this Congress. Patients aren’t interested in debating the timelines, the failure rates, the size and costs of conducting clinical trials. They just know that despite the promise of scientific breakthroughs, they can’t get the therapy that might save their lives one day. That is why we need 21st Century Cures. We are on the cusp of something special. A once-in-a-generation opportunity to transform how we treat disease. President Obama will sign this legislation into law next week and his help was critical in getting this new law enacted—so we say thank you Mr. President. A new day for medical research is on the horizon. A new day of hope for patients and their loved ones. We needed to do better. And with 21st Century Cures, we will. Thank you and have a blessed holiday season. Watch Chairman Upton’s address HERE. ### Read More

Walden Names Senior Staff for Energy and Commerce Committee

2016/12/09

WASHINGTON, DC – Rep. Greg Walden (R-Ore.), chairman-elect of the U.S. House Committee on Energy and Commerce, today announced that Mike Bloomquist, Karen Christian, Peter Kielty, and Paul Edattel will continue to serve the committee. All are longtime veterans of Capitol Hill. Bloomquist will serve as Deputy Staff Director for the Committee.  He has served in this position since August 2015. In addition, he previously served as the Committee General Counsel, Deputy General Counsel, as well as General Counsel to the 2011 Joint Select Committee on Deficit Reduction. Further, Mike has spent time in private practice, at the Committee on Science, and in the Office of the U.S. Department of the Interior. Christian will continue as Committee General Counsel, a position she has held since October 2014. Previously, she served as Chief Counsel for the Oversight and Investigations Subcommittee from 2012-2014, and was a member of the O&I staff since 2006. Karen spearheaded the Committee’s oversight of the Healthcare.gov failure and the federal loan guarantee to Solyndra. Her previous experience includes serving as counsel to the Committee on House Administration, a clerkship with a U.S. District judge and time spent in private practice.  Kielty will serve as Deputy General Counsel of the Committee. Kielty is a 15-year veteran of the Committee, and has served as Deputy General Counsel since 2012. Peter has advised on the parliamentary and jurisdictional matters before the Committee. Edattel will continue to serve as Chief Counsel to the Subcommittee on Health. Paul started with the Committee in 2011 and has served as Chief Health Counsel since 2016, after serving Speaker John Boehner as his health policy advisor. Paul also served as a Legislative Director in the House of Representatives before joining the Committee. "I am excited that Mike, Karen, Peter, and Paul are joining my team. They bring over 40 years of experience serving the Members of the Energy and Commerce Committee. I look forward to working closely with them and incoming-Staff Director Ray Baum to bring commonsense solutions to American families," said Chairman-elect Greg Walden. ###  Read More

Letter to OMB Director Shaun Donovan

2016/12/09

Excerpt: "We believe it is importatn that there be transparency and accountability with regard to the climate change related expenditures across the Federal government, and that Congress and the public should know how much is spent by Federal agenices, and for what purpose." To read the letter, click here.  Read More

Upton to Deliver Weekly Republican Address on #CuresNow

2016/12/09

WASHINGTON, DC –Today, House Speaker Paul Ryan (R-WI) announced that this week’s Republican address will be delivered by House Energy and Commerce Committee Chairman Fred Upton (R-MI). In the address, Chairman Upton will discuss the 21st Century Cures Act, groundbreaking medical innovation legislation signed by Speaker Ryan earlier this week. [[{"fid":"1969","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"240","width":"360","class":"media-element file-full"}}]] Chairman Upton speaks during Thursday’s enrollment ceremony for the 21st Century Cures Act. “We had an idea three years ago that patients deserved better—that medicine wasn't keeping pace with incredible advancements in science,” said Chairman Upton. “Patients needed an innovation game-changer, and we have it with 21st Century Cures. The landmark legislation will accelerate the discovery, development, and delivery of safe new cures and treatments. For families across the country, this legislation to help deliver #CuresNow marks a renewed dawn of hope.” “Fred Upton is one of the main reasons Americans will start to see improved medical care and healthier lives,” said Speaker Ryan. “The Cures Act will help researchers and doctors unlock the next generation of cures and treatments for their patients.” As he said at yesterday’s bill signing, “I could not think of a better way to end the year than by signing this bill.” Chairman Fred Upton represents the commonsense values of southwest Michigan with a district that stretches from the shores of Lake Michigan and includes key industries that range from automobile parts manufacturing to high-tech biomedical innovation centers. In 2010, Chairman Upton was selected by his House colleagues to serve as Chairman of the Committee on Energy and Commerce. In 2014, Chairman Upton unveiled the bipartisan 21st Century Cures initiative, a multi-year effort that aims to accelerate the pace of cures and medical breakthroughs in the United States. Learn about the 21st Century Cures Act HERE. NOTE: The Weekly Republican Address will be available starting Saturday, December 10, at 6:00 a.m. ET on speaker.gov. ### Read More

Thank you, Emily.

2016/12/09

Over the last three years, we’ve shared some remarkable stories and encountered some amazing people, defying the odds in their personal battles with disease. One of those individuals is Emily Muller of Chicago, Illinois. Emily and her friend, Shira Strongin have been vocal advocates on the #Path2Cures. What makes them unique is their age. Just a few months ago, Emily and Shira spent their summer vacation on social media, urging passage of the 21st Century Cures Act. From attention-grabbing graphics for their Cyber Rallies to making the rounds on Capitol Hill, everyone knew these teens meant business. And it is because of their efforts, and the help of energized patients like them, that 21st Century Cures is about to be signed into law. The #Path2Cures has been paved by people like Emily. Thank YOU for all your help. Together, we will deliver #CuresNow. [[{"fid":"1966","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"30","width":"154","class":"media-element file-full"}}]] December 7, 2016 #CuresNow By Emily Muller We passed #CuresNow. In less than three years I've had the opportunity to write numerous articles, host two cyber-rallies, engage with countless Congressmen, and make two trips to DC.  It has all been out of passion for this legislation.  I can't begin to put into words exactly what this means, so I'll start by saying thanks. Shira, thank you for spending Washington nights with me, dancing to synth pop in an old funeral parlor for the irony and allowing me to be with you while you grieved the loss of a dear friend in a hotel room.  Thank you mom for being the ultimate travel partner and allowing me to explore city streets and take cabs to the Rayburn Foyer.  Thank you dad for taking care of my precious pups when I'm away and always encouraging me to work for causes I care about. Thank you Stephanie and Max for the sugary breakfasts, late night emails and for giving a girl originally no more than 15 the chance to influence a movement.  Thank you Sean and Jennifer for making me comfortable enough to share my own ideas and being two of the most driven people I've ever been in contact with. Thank you Dr. Stone for getting me in Forbes with the best Californian friend a girl could have.  Thank you to all my advocate friends, especially Jamie, Tracy, and Ashanti, for being the most incredible lobbyists to learn from. Thank you Lisa Schill for providing me with endless inspiration even though I've never met your beautiful Max. Thank you to the skeptics that pushed me to stay educated and allowed me to prove myself as more than a misguided kid.  Thank you to the Congressmen that told me stories through the years and allowed me to see what history looks like.  Finally, Representative Upton, although we've never met you made this possible.  I could write for days about just how much your efforts mean to me but no words could ever be kind enough to capture the full extent of my feelings.  Thank you for Cures. Let us think of the friends we lost before they had the chance to see this day.  We'll continue to fight for them - to make it clear that no one else should have to suffer the way that they did in this life.  Treatment should be a right afforded to every American and with this legislation we're one step closer to having a regulatory process that works for individuals with rare disease.  I hope that if I have children they will never hear the words "there is no treatment," and I hope that they won't know the pain of burying friends. Let's celebrate but never forget that we've still got work to do.  OPEN Act is next.  Just you wait. [[{"fid":"1967","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"203","width":"271","class":"media-element file-full"}}]] Photo from my first trip to DC. Carnegie Institution for Science. Age 15. Click HERE to read the blog post online. ### Read More

#SubCMT Examines the Mixed Martial Arts Industry

2016/12/08

[[{"fid":"1964","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"1753","width":"3888","style":"width: 450px; height: 203px;","class":"media-element file-full"}}]] WASHINGTON, DC – The Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing to examine the economic potential and issues at play within the Mixed Martial Arts (MMA) industry. The hearing provided an opportunity to learn more about this popular and quickly-growing sport. During the hearing, members discussed the health and safety of fighters, the economic potential of this industry, and reviewed the current rules and regulations guiding the sport.  Providing members with a brief overview of the athleticism and training required of fighters, Randy Couture, President of Xtreme Couture, testified, “(I)t is a sport that involves world-class and Olympic athletes involved in all disciplines of martial arts, including wrestling, judo, jiu-jitsu, muay-thai, karate and boxing.” Drawing distinct differences between boxing and MMA, Mr. Couture outlined some of the challenges fighters face with regard to promotional titles, long-term contracts, and merchandising. A reoccurring theme echoed by witnesses and members alike throughout the hearing is the broad success and popularity of MMA across the country. While each state has legalized MMA, regulations vary from state to state. Chairman Burgess noted “State athletic commissions have generally promulgated rules that prohibit certain maneuvers in the ring, require certain equipment, and provide for athlete drug testing.” He goes on, commenting that “[s]ome states are stricter than others, depending on the state’s resources and how popular the state is as a venue for MMA.” [[{"fid":"1965","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"2444","width":"2504","style":"width: 450px; height: 439px;","class":"media-element file-full"}}]] Chairman Burgess speaks with Randy Couture at the conclusion of the #SubCMT hearing. Jeff Novitzky, the Vice President of Athlete and Health Performance at the UFC, relayed that much emphasis is placed on educating athletes and coaches on “relevant health and safety issues” so they can train and fight in a safer manner. He continues, “Our goal is to make them [fighters] more informed, and thus practice safer weight management to mitigate any health consequences and help maximize their performance.” Offering similar sentiments on the importance of fighter safety was Lydia Robertson, the Treasurer of the Association of Boxing Commissions. Recalling the important theme of training to ensure safety she said, “The ABC’s interest is [always] focused on fighter health and safety.  How do we protect fighters, sometimes from themselves, and yet still allow the mixed martial arts to be a competition?  What medical minimum standards should be in place? Our interest is [always] on the fighter, fair treatment of the athletes, and their future.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. Read More

Delivering #CuresNow: Speaker Ryan Signs Bipartisan Game-Changing Medical Innovation Bill

2016/12/08

[[{"fid":"1961","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"3648","width":"5472","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] WASHINGTON, DC – Following the Senate’s passage of the 21st Century Cures Act on Wednesday by a vote of 94 to 5, the bill was sent today to Speaker Paul Ryan (R-WI) before moving to the White House for the president’s signature. The House passed the game-changing medical innovation bill on November 30, by a vote of 392 to 26. Both Speaker Ryan and Senate Pro Tempore Orrin Hatch (R-UT) officially signed the bill at this morning’s Enrollment Ceremony. [[{"fid":"1962","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"3648","width":"5472","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] With Speaker Ryan’s signature, the bill now heads to the president’s desk. “This effort has always been about the patients, and I’m so glad that we could have our friend, all-star Cures advocate Max with us today. Not letting rare disease hold him back, this pint-sized dynamo has been with us every step of the way on the #Path2Cures,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). “We look forward to seeing President Obama make #CuresNow law next week. As Max said today, ‘Cures is more than hope, it’s action.’ Next stop, the White House!” For more information on the 21st Century Cures Act, click HERE.   Read More

#RECORDOFSUCCESS: House Clears Water Infrastructure Improvements Act

2016/12/08

[[{"fid":"1963","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"415","width":"831","style":"width: 450px; height: 225px;","class":"media-element file-full"}}]] WASHINGTON, DC – The House of Representatives today passed the Water Infrastructure Improvements for the Nation (WIIN) Act, a comprehensive water resources infrastructure bill, in a bipartisan vote of 360-61. The bill is the culmination of work between multiple committees and authorizes port, waterway, and flood protection, and other water resources’ infrastructure across the country. A number of Energy and Commerce Committee priorities are part of the comprehensive bill. The WIIN Act includes authorizing funds addressing the situation in Flint, Michigan including: Authorizing funds to address the drinking water crisis in Flint, Michigan. $100 million in Drinking Water State Revolving Fund Capitalization Grants, $20 million for the Water Infrastructure Finance and Innovation Act, $17.5 million for lead registry, $2.5 million for the Lead Advisory Council, $15 million for the childhood lead prevention program at the CDC, and; $15 million for the Healthy Start Initiative. It also addresses control of coal combustion residuals, long championed by Environment and the Economy Subcommittee Chairman John Shimkus (R-IL) and committee member Rep. David McKinley (R-WV). This section: Provides for the establishment of state and EPA permit programs for coal combustion residuals (coal ash), and; Provides flexibility for states to incorporate the EPA final rule for coal combustion residuals or develop other criteria that are at least as protective as the final rule. The WIIN Act also contains public notification similar to provisions in H.R. 4470, which passed the House this passed February with 412 votes and kicked-off our bipartisan legislative response to the drinking water crisis in Flint. For more information on the WIIN Act, click HERE. “Folks in Flint are tired of the partisan blame game. They want answers and they want results. That is why we worked to hard to have language included in this bipartisan bill that authorizes funding to help improve the health of the people in Flint, and other communities who have had federal emergencies declared due to unsafe levels of lead in their drinking water,” concluded Energy and Commerce Committee Chairman Fred Upton (R-MI). “This important legislation also includes a thoughtful solution to coal ash that we have been working on for years. This bill provides for the establishment of state and EPA permit programs and provides states the flexibility needed, all the while maintaining EPA protections.”   ###  Read More

Mixed Martial Arts: Issues and Perspectives

2016/12/08

[[{"fid":"1958","view_mode":"full","fields":{"format":"full"},"type":"media","link_text":null,"attributes":{"alt":"Mixed Martial Arts: Issues And Perspectives","height":"380","width":"640","class":"media-element file-full"}}]] Read More

TODAY: Speaker Ryan, Members of House & Senate to Sign Bipartisan 21st Century Cures Act

2016/12/08

WASHINGTON, DC – Today, House Speaker Paul Ryan (R-WI) and members of the House and Senate will hold an enrollment ceremony for the bipartisan 21st Century Cures Act at 11:15 a.m. ET in the Rayburn Room of the U.S. Capitol. [[{"fid":"1957","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"239","width":"306","class":"media-element file-full"}}]] Max proudly wearing his #CuresNOW button. Today’s ceremony will include Max Schill, and his mother, Lisa. Max, who was born with a rare disease called Noonan Syndrome, has been a leading advocate for this bipartisan legislation. Max turns 8 next week, and as he wrote on GOP.gov, “My birthday wish is that 21st Century Cures will pass and become a law.” Details: Enrollment ceremony for the 21st Century Cures Act Thursday, December 8, at 11:15 a.m. ET Rayburn Room, United States Capitol Participants: House Speaker Paul Ryan (R-WI) Senate Majority Leader Mitch McConnell (R-KY) House Democratic Leader Nancy Pelosi (D-CA) House Energy and Commerce Committee Chairman Fred Upton (R-MI) Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) Senator Patty Murray (D-WA) Rep. Diana DeGette (D-CO) Members of Congress Media coverage: All TV crews must contact the House Radio-TV Gallery to sign up for coverage at 202-225-5214. Media may access the Rayburn Room at 9:00 a.m. ET. All crews with equipment must be set by 10:15 a.m. ET for the security sweep. Note: This event is open to members of Congress and credentialed press. The bill signing will be live-streamed on speaker.gov/live. Learn about the 21st Century Cures Act HERE. ### Read More

#RecordOfSuccess: Blackburn Bill Protecting Consumers With Better Online Ticket Sales Heads to President

2016/12/07

WASHINGTON, DC – On Wednesday evening, the House passed S. 3183, the Better Online Ticket Sales (BOTS) Act of 2016. The legislation has been spearheaded by Energy and Commerce Committee Vice Chairman Marsha Blackburn (R-TN). The bipartisan bill would empower the Federal Trade Commission (FTC) to stop scalpers from buying swaths of event tickets by going around defense measures put in place to prevent such bulk purchases. The House-version of this legislation, H.R. 5104, passed the House by voice vote in September. “Having the BOTS bill signed into law is a victory for consumers, sports fans and live concert goers,” said Vice Chairman Marsha Blackburn (R-TN). “It is time to end these anti-consumer tactics and level the online ticket playing field for fans of live entertainment. Thank you to my colleagues who have worked with me on a bipartisan bicameral basis to support my legislation, achieve passage and witness its being signed into law.” Full committee Chairman Fred Upton (R-MI) added, “For too long scalping software has taken advantage of the online ticket sales’ process, cheating thousands of fans from enjoying live events and other one-of-a-kind experiences. But this underhanded practice ends today, with passage of the BOTS Act, as it helps sustain a fair and transparent online-purchasing experience. With Rep. Blackburn’s bill, consumers are back on a level playing field when it comes to securing tickets to big time concerts like Bruce Springsteen, or seeing the World Champion Chicago Cubs. This commonsense bill builds upon our proud record of success and I look forward to the president swiftly signing it into law.” Over the past year, the committee has worked to modernize government policies for the innovation era through the ongoing Disrupter Series. Specifically, the committee examined the type of reforms the FTC must undergo in order to keep pace with 21st century innovation. The BOTS Act is just one example of legislation that resulted from this series’ effort to modernize the FTC and promote innovation. Learn more about the Energy and Commerce Committee’s #RecordOfSuccess HERE. Read More

#SubHealth Reeling in Government Waste in Catfish Inspection Program

2016/12/07

WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Joe Pitts (R-PA), today held a hearing examining the waste and duplication in the USDA’s Catfish Inspection Program. The FDA is already responsible for overseeing the safety and inspection of seafood. “What is it about catfish? Interestingly enough – nothing! Catfish is an extremely low risk food product,” stated Chairman Pitts. “Explicitly creating a program exclusively for catfish is unnecessary and directs resources away from high risk foods to focus on a food that is one of the safest.” Kimberly Gorton, President and CEO of Slade Gorton & Co., Inc, stated, “As someone with decades of first-hand experience in the American seafood industry, I can honestly say that both the regulator and the regulated industry are doing a better job than ever before.” Gorton also shared the story of their third-generation family business, adding, “The USDA program is a complete waste of tax dollars. Our government is already squeezing job-creating small businesses, and this program is a needless, costly and duplicative regulation that burdens my company and all other seafood companies.” Justin Conrad, President of Libby Hill Seafood Restaurants, Inc. testified saying, “The Government Accountability Office has 10 times called the USDA program a waste of tax dollars and at high risk for abuse. GAO even put out a report stating catfish regulation should not be assigned to USDA.” Today’s hearing, the last for #SubHealth this Congress, was also the last for Chairman Pitts. [[{"fid":"1955","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"206","width":"278","class":"media-element file-full"}}]] #SubHealth committee members applaud Chairman Pitts’ leadership and work. “Joe Pitts has been a leader for some of the committee’s greatest accomplishments: reforming how Medicare pays America’s physicians, improving the safety of our nation’s drug supply chain, advancing dozens of bills to improve our nation’s public health, and helping shepherd through the 21st Century Cures Act that will land shortly on President Obama’s desk,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). “I wish nothing but the best to you and Ginny in this next chapter.” For more information on today’s hearing including a background memo, witness testimony, and an archived webcast click here. ### Read More

Walden and Yarmuth Introduce Bill Eliminating Disco Era Media Ownership Rules

2016/12/07

WASHINGTON, DC – Communications and Technology Subcommittee Chairman Greg Walden (R-OR) and committee member Rep. John Yarmuth (D-KY) today introduced a bipartisan bill to repeal the newspaper broadcast cross-ownership ban. Enacted in 1975, the cross-ownership rule prohibits ownership of both a broadcast station (AM, FM, TV) and a daily newspaper in the same market. Despite the fact that the FCC, in 2003, found the ban to no longer be in the public interest, the rule remains largely unchanged and hinders potential investment in struggling newspapers across the country. The bipartisan bill would eliminate the 1970s era cross-ownership ban to reflect today’s competitive media marketplace, providing greater flexibility to newspapers and broadcasters. “This bipartisan effort finally acknowledges that our current media landscape is far different than it was nearly 50 years ago,” said Rep. Yarmuth. “As we’ve seen the rise in fake news and its consequences, it is increasingly important that we do all we can to protect legitimate sources of news. This legislation would give media entities the flexibility they need to compete and grow in this challenging marketplace.” “Times have changed, and it’s critical our media ownership rules keep pace with the innovation era. This bipartisan bill is just the latest in our continued efforts to modernize outdated rules and promote investment in the communications sector,” said Chairman Walden. “Broadcasters and newspapers face intense competition from cable and the Internet. Eliminating this relic of the disco era will provide much needed flexibility to the many newspapers and broadcasters throughout the country that provide important local news coverage and encourage greater investment in original journalism. We want what’s best for consumers and this bill provides a thoughtful solution that puts the public’s interest first.” To view the text of the bill, click HERE. ###  Read More

BREAKING: “21st Century Cures Is Ready for the President”

2016/12/07

[[{"fid":"1953","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"246","width":"468","class":"media-element file-full"}}]] WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), sponsors of the 21st Century Cures Act, issued the following statement after the Senate passed the medical innovation bill by a vote of 94-5. “After three years, our legislative work is finally complete. 21st Century Cures is ready for the president,” said Upton and DeGette. “With this innovation game-changer, a new day for medical research is on the horizon. Today’s vote is for patients and their loved ones. We all have more reason for hope.”  Learn about the 21st Century Cures Act HERE. ### Read More

Waste and Duplication in the USDA Catfish Inspection Program

2016/12/07

[[{"fid":"1950","view_mode":"full","fields":{"format":"full"},"type":"media","link_text":null,"attributes":{"alt":"Waste and Duplication in the USDA Catfish Inspection Program","height":"380","width":"640","class":"media-element file-full"}}]] Read More

#CuresIn4Words: Game-Changing, Innovative Breakthrough

2016/12/07

Ahead of the Senate’s vote to pass the 21st Century Cures Act this afternoon, The Wall Street Journal is labeling the effort a “breakthrough” in Congress. The Editorial Board writes, “Medicine moves faster than government, thank goodness, but every now and again government tries to catch up. After years of thoughtful bipartisan work, Congress is now poised to pass the 21st Century Cures Act, a bill designed to accelerate the development of new medicines and modernize a malfunctioning corner of the regulatory state.” To learn more about 21st Century Cures, click here. [[{"fid":"1949","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"47","width":"396","class":"media-element file-full"}}]] December 6, 2016 EDITORIAL: Congress’s Cures Breakthrough Medicine moves faster than government, thank goodness, but every now and again government tries to catch up. After years of thoughtful bipartisan work, Congress is now poised to pass the 21st Century Cures Act, a bill designed to accelerate the development of new medicines and modernize a malfunctioning corner of the regulatory state. The sweeping measure cleared a Senate procedural vote 85-13 on Monday night and passed the House 392-96. These margins are testimony to renewed self-confidence in U.S. innovation and health-care progress, not much expressed in Washington until recently. A few dead-enders like Bernie Sanders and Elizabeth Warren are denouncing Cures for its lack of pharmaceutical price controls, which might have become a reality had Hillary Clinton won on Nov. 8. Cures includes a $4.8 billion infusion for the National Institutes of Health for basic research. The bill funds the NIH’s neurological program on diseases like Alzheimer’s, Joe Biden’s “cancer moonshot” and rare diseases, while one encouraging earmark is for “high risk, high reward” studies that might not be financed by the private economy. By the way, these new dollars are roughly offset with budget cuts elsewhere, which exposes the liberal claims of crisis if every program doesn’t last forever. Congress is supposed to set priorities. … Read the full editorial online HERE. ###   Read More

#RecordOfSuccess: Seven More Clear the Floor

2016/12/06

[[{"fid":"1945","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"208","width":"396","class":"media-element file-full"}}]] WASHINGTON, DC – The House of Representatives today advanced seven Energy and Commerce Committee bills, building on the committee’s bipartisan #RecordOfSuccess. To date, over 130 bipartisan Energy and Commerce bills and provisions have cleared the House. “With seven more clearing the floor, we continue to build upon the committee’s proud #RecordOfSuccess. From fighting childhood cancer to helping our vets, these bipartisan bills taken together are a testament to the hard work and dedication of our members to make a difference. Our work continues,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). The bills passed by the House today were: H.R. 756, Streamlining Energy Efficiency for Schools Act of 2015, authored by Rep. Matt Cartwright (D-PA), would make it easier for schools to take advantage of federal programs to help them cut down on energy use. H.R. 756 passed unanimously by voice vote. H.R. 6375, Power And Security Systems (PASS) Act, authored by committee member Rep. Mike Pompeo (R-KS), would provide an exemption from energy use restrictions for equipment that needs to be on at all times, such as security systems or heart monitors. H.R. 6375 passed unanimously by voice vote. H.R. 3381, Childhood Cancer STAR Act, authored by Rep. Michael McCaul (R-TX), would allow the National Institutes of Health to provide support in collecting information from children, teens, and young adults with cancer, to gain a better understanding of the effects of various treatments. The Centers for Disease Control and Prevention would award grants to states to help improve tracking of childhood cancers. H.R. 3381 passed unanimously by voice vote. H.Res 939, Expressing the sense of the House of Representatives that all students should have access to the digital tools necessary to further their education and compete in the 21st century economy. The measure is authored by committee member Rep. Peter Welch (D-VT). H. Res 939 passed by a vote of 414-1. H.R. 6394, Improving Broadband Access for Veterans Act of 2016, authored by committee member Rep. Jerry McNerney (D-CA), would require the Federal Communications Commission to study and report to Congress on the availability of broadband for America’s veterans. H.R. 6394 passed by a vote of 411-4. H.Res. 932, Expressing the sense of the House of Representatives that protections against unwanted third-party charges on consumer telephone bills should be improved to empower consumers. The measure is authored by committee member Rep. Jan Schakowsky (D-IL). H.Res. 932 passed unanimously by voice vote. S. 2873, Expanding Capacity for Health Outcomes (ECHO) Act, authored by Sen. Orrin Hatch (R-UT) would require the Department of Health and Human Services to study technology-enabled collaborative learning and capacity building models to improve patient care and provider education. S. 2873 passed unanimously by voice vote. ### Read More

Murphy On Superbug Threat: “People Better Start Paying Attention.”

2016/12/06

In the midst of a critical two week stretch on the #Path2Cures, the battle to deliver cures and cutting-edge treatments is being fought on all fronts. On last Sunday’s edition of Full Measure with Sharyl Attkisson, Rep. Tim Murphy (R-PA), Chairman of the Subcommittee on Oversight and Investigations, called attention to a growing public health threat – superbugs. “Superbugs, which are antibiotic resistant bacteria, are the greatest infection threat in our country right now,” said Chairman Murphy. “Far more people die of infections that can’t be treated than people die of AIDS. The other thing about this is that it’s getting worse. We don’t have cures for this and people better start paying attention.” For more information on the subcommittee’s work on superbugs, click here. To learn more about 21st Century Cures, click here. [[{"fid":"1947","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"206","width":"376","style":"width: 300px; height: 164px;","class":"media-element file-full"}}]] December 4, 2016 Superbugs [[{"fid":"1948","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"451","width":"804","class":"media-element file-full"}}]] Watch the story HERE. Read More

#SubOversight Reviews EPA’s Role in Implementation of VW Settlement

2016/12/06

WASHINGTON, DC – The Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), today held a hearing examining the investment commitments attached to the recently approved Partial Consent Decree in the Volkswagen “Clean Diesel” settlement as well as the Environmental Protection Agency’s (EPA) role in implementing the settlement’s terms. Specifically, members questioned EPA officials regarding the $2 billion investment Volkswagen is required to make in Zero Emission Vehicle (ZEV) infrastructure, as well as the $2.7 billion to be paid into the NOx Mitigation Trust. The hearing builds upon letters sent by full committee Chairman Fred Upton (R-MI) and Chairman Murphy in early November requesting information from EPA on the settlement implementation.  [[{"fid":"1942","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"212","width":"287","class":"media-element file-full"}}]] In his questioning, committee member Rep. Bill Flores (R-TX) asked EPA if any analysis has been done regarding the ZEV investment commitment, and what detailed analysis the agency did “to take a market that’s just starting and then to jam” a couple billion into it? Flores also inquired, “What detailed analysis did the EPA do to see what impact that would have on the market?” To which, Cynthia Giles, Assistant Administrator at the Office of Enforcement and Compliance Assurance at the EPA said, “We did not do a detailed analysis.” Rep. Flores then asked Assistant Administrator Giles, “My question is this. Doesn’t it make sense to rigorously study this important question before requiring a defendant accused of cheating customers and the U.S. government to flood a growing market with $2 billion of capital?” [[{"fid":"1944","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"209","width":"279","class":"media-element file-full"}}]] Watch Murphy Press EPA’s Giles here. Subcommittee Chairman Murphy questioned Assistant Administrator Giles regarding competitiveness in the ZEV infrastructure, stating, “Some have suggested that this could have a negative or anti-competitive effect on the existing ZEV infrastructure. Do you agree?” “We are not here today to ask EPA to renegotiate the agreement, but now that it’s final, we need to understand how it will work, how it will affect businesses already in the zero-emission-vehicle marketplace and what EPA’s role is in administering this huge financial commitment,” concluded Chairman Murphy. “VW betrayed the public trust with its cheating scandal. We are here today to ensure the agencies responsible for developing and agreeing to this deal will ensure the public interest is protected.” For more information on today’s hearing including a background memo, witness testimony, and an archived webcast click here. ###  Read More

Volkswagen’s Emissions Cheating Settlement: Questions Concerning ZEV Program Implementation

2016/12/06

[[{"fid":"1940","view_mode":"full","fields":{"format":"full"},"type":"media","link_text":null,"attributes":{"alt":"Volkswagen's Emissions Cheating Settlement: Questions Concerning ZEV Program Implementation?","height":"380","width":"640","class":"media-element file-full"}}]] Read More

Upton & DeGette: “#CuresNow, it’s going to happen.”

2016/12/05

[[{"fid":"1936","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"199","width":"521","class":"media-element file-full"}}]] Chairman Fred Upton, Rep. Diana DeGette, and Rep. Tim Murphy heading to the Senate floor ahead of the cloture vote with some special guests – Friends of Cancer Research founder and chairperson Ellen Sigal, and NIH Director Francis Collins. WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), sponsors of the 21st Century Cures Act, issued the following statement following the Senate’s cloture vote this evening, clearing the way for a swift vote on passage. “With today’s resounding vote, we’re excited the decks have been cleared for 21st Century Cures,” said Upton and DeGette. “This effort represents the very best of Congress, coming together and working toward a greater cause, a cause for hope. We were particularly delighted to share in the moment with Vice President Biden, NIH’s Dr. Collins, and Ellen Sigal. This is a big deal. After three years on the #Path2Cures, there’s a light at the end of the tunnel, and it’s called the White House. We can say with certainty - #CuresNow, it’s going to happen.” Learn about the 21st Century Cures Act HERE. ### Read More

House-Senate Committee Leaders’ Statement on Water Resources Infrastructure Legislation

2016/12/05

WASHINGTON, DC – House Energy and Commerce Chairman Fred Upton (R-MI), House Transportation and Infrastructure Chairman Bill Shuster (R-PA), Senate Environment and Public Works Committee Chairman Jim Inhofe (R-OK), and House Natural Resources Chairman Rob Bishop (R-UT) today announced an agreement on comprehensive water resources infrastructure legislation. The legislation, the “Water Infrastructure Improvements Act for the Nation (WIIN) Act,” includes the Water Resources Development Act (WRDA), which authorizes port, waterway, and flood protection improvements for the country. The WIIN Act also includes the Water and Waste Act of 2016 to help communities meet the requirements of the Safe Drinking Water Act and authorize state regulation of coal ash. In addition, the legislation addresses significant tribal and natural resources issues. The House and Senate both overwhelmingly passed WRDA bills earlier this year, and the WIIN Act is the product of the resulting bicameral negotiations. The Committee Chairmen released the following joint statement: “The WIIN Act invests in American competitiveness by addressing our port, waterway, flood protection, and other water resources’ infrastructure across the country. It addresses public health by tackling lead contamination and helping communities, like Flint, provide safe drinking water, and encouraging cost-saving innovative drinking water technologies. It also provides infrastructure assistance for Indian country and certainty for several water rights settlements. “The WIIN Act is the result of hard work and collaboration among our committees and will strengthen the nation’s transportation and water infrastructure and our economic competiveness. We look forward to moving this legislation and sending it to the president before the end of the year.” Click here for the legislative text of the WIIN Act. Click here for a summary of the WIIN Act. ###  Read More

#CuresNow: “It shows what we can do when we work together.”

2016/12/05

WASHINGTON, DC – Following Wednesday’s monumental House vote on the 21st Century Cures Act, the bill’s original sponsors recorded a special video message. Highlighting her daughter’s battle with type I diabetes, Rep. Diana DeGette (D-CO) reinforced that every family has a connection to disease. “It’s personal for everyone here. We're going to really impact millions of lives, and it's a great bipartisan win. It shows what we can do when we work together,” added Energy and Commerce Committee Chairman Fred Upton (R-MI). Watch their message below. [[{"fid":"1933","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"261","width":"467","class":"media-element file-full"}}]] Watch Chairman Upton and Rep. DeGette deliver a special message HERE. To learn more about the 21st Century Cures Act, click HERE. ###  Read More

#CuresIn4Words: All About the Patients

2016/12/05

[[{"fid":"1931","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"151","width":"288","class":"media-element file-full"}}]] Ever wonder why the effort to deliver #CuresNow is so important to patients? Medical expert and cancer survivor Elaine Schattner explained why in a recent column in Forbes. 21st Century Cures is the product of three years of work. At every step of the way, patients and regulators like the NIH and FDA have offered their guidance on what would help accelerate the discovery, development, and delivery of new cures and treatments. Patients need a game-changer. [[{"fid":"1930","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"53","width":"148","class":"media-element file-full"}}]] November 30, 2016 Why Patients Support the 21st Century Cures Act By Elaine Schattner … I’ve seen stories suggesting that “Cures” is all about perks for pharmaceutical companies, and that industry-funded advocacy groups are parading patients, like puppets, before legislators to promote the bill. Earlier this year, I attended a small meeting where healthcare journalists didn’t just question, but scoffed at the prospect of speeding the FDA’s approval process, which is part of the package. “Why would anyone support this bill?” a journalist asked. The fact is, every patient with whom I have discussed the 21st Century Cures Act hopes it will move forward. Doctors too, tend to favor this bill, because it supports more government-funded research. I support most of the “Cures” provisions, for three big-picture reasons. First, the legislation includes significant investment for President Obama’s Precision Medicine Initiative and the real Cancer Moonshot. I agree with oncologists who observe that we’re at a pivotal moment in cancer research, ready to turn in-hand progress in science and information technology into survival and quality-of-life advantages. Second, because this legislation will enable the FDA to modernize its ways of evaluating new treatments, including more input from patients. In this age of open information and Facebook groups with patients trading stories of medication toxicity, I’m less afraid of bad drugs getting approved than of having a bureaucracy block their availability to people who want to try those. Third, because this legislation has the potential to keep the U.S. at the forefront of medical progress, a draw for scientists and doctors around the world, a source of pride. Janet Freeman-Daily is one of many patients with whom I’ve discussed the 21st Century Cures Act. At age 60, she’s an MIT and CIT-educated engineer who lives in Seattle with her husband. She’s been alive with advanced lung cancer for five years, and counting several beyond what she expected. The only thing she’s ever smoked is salmon, she said. Her 2011 diagnosis came as a surprise, at age 55. After standard treatments with radiation and chemotherapy for stage 3 disease, metastatic disease became evident in bones and elsewhere. Fortunately, Freeman-Daily has family in Denver and sought consultation at the University of Colorado. An oncologist there advised sequencing of her tumor. Molecular studies revealed an altered ROS1 gene in her lung cancer cells. This mutation renders the tumor sensitive to crizotinib. This drug, sold by Pfizer as Xalkori, was FDA-approved for advanced lung cancer with ALK1 mutations in 2011. Its on-label use has since been extended to ROS1-mutated cases. Freeman-Daily supports the 21st Century Cures Act because it will promote research and patients’ access to new drugs. “I like the focus on precision medicine, infectious diseases and pediatrics, with global studies,” she told me by phone. “The plan to include more patients’ voices is great,” she added. “Mainly it’s good for research. We’ve got to let our scientists do science and stop worrying about paperwork.” “They’re talking about accelerating approval of drugs for patients with rare diseases and oncogene-driven cancers like mine.” Many of these are conditions are infrequent; it would be extremely difficult if not impossible to collect sufficient numbers of patients for separate clinical trials of each drug in each condition. “The nearest trial for me is one thousand miles away, in Denver.” Freeman-Daily travels to check in for her clinical trial. “Many patients can’t travel.” That’s why greater flexibility in trial design for evaluating precision medicine drugs is needed, she considered. “I understand the concerns for rigor and safety,” she considered. “But if we wait until the results of phase 3 trials are available, how many of us are going to die in the meantime? If you’re out of other options, you’re willing to take a bit of a risk if you want to stay alive.” Peter Pitts is a former associate FDA commissioner and co-founder of the Center for Medicine in the Public Interest. His experiences as a person with congestive heart failure influence but don’t define his views on medical care, he told me in a phone interview. “Like many people in the health policy field, I have a health condition,” he said. “I care deeply about these issues.” “I’m a big supporter of the bill” Pitts said, referring to the 21st Century Cures legislation. “What it says for patients is that their voices will be heard more regularly and taken seriously,” Pitts said. “That is a good thing for public health.” “There are no white hats and black hats in this,” he said. Health are is like an ecosystem, he suggested. It will only work if all the people involved, all the players–including physicians, payers, industry, regulators and patients themselves–take a role in helping patients to achieve better health. Pitts takes a positive view of proposed changes for the FDA. “The agency is at center of innovation,” he said. “It does much more than expedite approvals and bring drugs to market. The agency is responsible for distributing truthful, accurate and non-misleading information, beyond what’s on the labels,” he said. “That is crucial for physicians and for patients.” “The most important shift that is embodied in the 21st Century Cures act is that it goes beyond pure regulatory science, for the FDA, to understanding and incorporating what patients feel is appropriate,” Pitts said. I asked Pitts about some concerns for the FDA lowering standards for drug approval. “The FDA is at a crossroads now,” he considered. “If some people think the FDA is moving too quickly, and some people think it’s too slowly, then it’s probably doing things just about right,” he said. “At the end of the day, I think patients want the FDA to be innovative, aggressive and prudent. That’s a nice public health triple play.” To read the full column online, click HERE. ### Read More

Upton on #CuresNow: “We’re going to save lives.”

2016/12/04

Three years ago, Energy and Commerce Committee Chairman Fred Upton (R-MI) had an idea, that patients needed an innovation game-changer in how we fight disease. From there, the journey on the #Path2Cures was soon underway. We’ve made a lot of friends along the way, and every single voice in support of #CuresNow has made a difference, building incredible momentum. From patient advocacy groups, leading researchers, and beyond, an overwhelming 392-26 vote in the House, and a new show of strong support from President Obama, the finish line is in sight. 21st Century Cures has always been about the patients. From dozens of roundtables and hearings across the country and in Washington, Congress listened to the patients who have always remained the singular focus of this unprecedented effort. Every single American has been touched by disease, making this effort so important and personal. This new video from the House Republican Conference captures the essence of #CuresNow. As Chairman Upton said shortly after the House vote, “We’re going to save lives.” [[{"fid":"1929","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"406","width":"737","class":"media-element file-full"}}]] Watch the video from the House Republican Conference HERE. To learn more about 21st Century Cures, click here. ### Read More

THROUGH THE LENS: #CuresNow

2016/12/04

[[{"fid":"1922","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"3648","width":"5472","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] An Inside Look Through the Lens of the Energy and Commerce Committee During the Week of #CuresNow [[{"fid":"1923","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"240","width":"716","class":"media-element file-full"}}]] Chairman Fred Upton (R-MI) joins Majority Leader McCarthy (R-CA), House Majority Whip Steve Scalise (R-LA), Rep. Tim Murphy (R-PA), and Conference Chairwoman Cathy McMorris Rodgers (R-WA) at the GOP leadership stakeout Wednesday morning. [[{"fid":"1925","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"366","width":"550","class":"media-element file-full"}}]] House Speaker Paul D. Ryan sporting a #CuresNow button minutes before the historic vote. [[{"fid":"1926","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"2592","width":"3888","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] Rep. Diana DeGette (D-CO) and Chairman Upton meet in Statuary Hall immediately following the #CuresNow vote. [[{"fid":"1924","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"2592","width":"3888","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] Chairman Upton joins other GOP members after passage of #CuresNow to thank everyone for their support.  [[{"fid":"1927","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"693","width":"1032","style":"width: 450px; height: 302px;","class":"media-element file-full"}}]] 392-26. [[{"fid":"1928","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"2448","width":"3264","style":"width: 450px; height: 338px;","class":"media-element file-full"}}]] House Majority Whip Scalise had a special message for Energy and Commerce Committee members following the House’s passage of #CuresNow. View additional photos in our Facebook album HERE.   Read More

TRENDING: #CuresNow

2016/12/03

[[{"fid":"1883","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"674","width":"496","style":"width: 300px; height: 408px;","class":"media-element file-full"}}]]   E&C members dominated social media this week to feature their support of #CuresNow. The momentum on the #Path2Cures continued to grow leading up to the historic vote, when #CuresNow reached the number one trending spot on Twitter. All week long, members eagerly highlighted their enthusiastic support through floor speeches, graphics, and even a few #CuresNow buttons. With a final vote of 392-26, this medical innovation package now heads to the Senate. Check out what members had to say about the #Path2Cures below. [[{"fid":"1920","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"89","width":"559","class":"media-element file-full"}}]] [[{"fid":"1884","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"445","width":"579","style":"width: 450px; height: 346px;","class":"media-element file-full"}}]] [[{"fid":"1919","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"100","width":"576","style":"width: 550px; height: 95px;","class":"media-element file-full"}}]] [[{"fid":"1887","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"386","width":"415","class":"media-element file-full"}}]] [[{"fid":"1888","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"130","width":"582","style":"width: 450px; height: 101px;","class":"media-element file-full"}}]] [[{"fid":"1890","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"70","width":"579","class":"media-element file-full"}}]] [[{"fid":"1891","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"334","width":"575","style":"width: 475px; height: 276px;","class":"media-element file-full"}}]] [[{"fid":"1892","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"545","width":"443","style":"width: 443px; height: 545px;","class":"media-element file-full"}}]] [[{"fid":"1893","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"460","width":"574","style":"width: 475px; height: 381px;","class":"media-element file-full"}}]] [[{"fid":"1894","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"411","width":"443","class":"media-element file-full"}}]] [[{"fid":"1895","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"216","width":"578","style":"width: 500px; height: 187px;","class":"media-element file-full"}}]] [[{"fid":"1897","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"456","width":"580","style":"width: 475px; height: 373px;","class":"media-element file-full"}}]] [[{"fid":"1898","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"392","width":"577","class":"media-element file-full"}}]] [[{"fid":"1899","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"531","width":"418","class":"media-element file-full"}}]] [[{"fid":"1900","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"599","width":"583","style":"width: 475px; height: 488px;","class":"media-element file-full"}}]] [[{"fid":"1901","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"456","width":"412","class":"media-element file-full"}}]] [[{"fid":"1902","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"101","width":"576","class":"media-element file-full"}}]] [[{"fid":"1903","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"291","width":"419","class":"media-element file-full"}}]] [[{"fid":"1904","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"297","width":"614","style":"width: 500px; height: 242px;","class":"media-element file-full"}}]] [[{"fid":"1905","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"277","width":"444","class":"media-element file-full"}}]] [[{"fid":"1906","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"525","width":"420","class":"media-element file-full"}}]] [[{"fid":"1907","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"128","width":"580","style":"width: 500px; height: 110px;","class":"media-element file-full"}}]] [[{"fid":"1908","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"404","width":"576","style":"width: 475px; height: 333px;","class":"media-element file-full"}}]] [[{"fid":"1909","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"404","width":"583","style":"width: 475px; height: 329px;","class":"media-element file-full"}}]] [[{"fid":"1910","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"105","width":"579","style":"width: 500px; height: 91px;","class":"media-element file-full"}}]] [[{"fid":"1911","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"371","width":"583","style":"width: 475px; height: 302px;","class":"media-element file-full"}}]] [[{"fid":"1912","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"440","width":"440","class":"media-element file-full"}}]] [[{"fid":"1913","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"452","width":"418","class":"media-element file-full"}}]] [[{"fid":"1914","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"443","width":"578","style":"width: 475px; height: 364px;","class":"media-element file-full"}}]] [[{"fid":"1915","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"393","width":"581","style":"width: 475px; height: 321px;","class":"media-element file-full"}}]] [[{"fid":"1916","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"82","width":"497","class":"media-element file-full"}}]] [[{"fid":"1917","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"495","width":"420","class":"media-element file-full"}}]] [[{"fid":"1918","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"361","width":"583","class":"media-element file-full"}}]]   Read More

BREAKING: Tim Kaine Is On the #Path2Cures

2016/12/02

Support for #CuresNow continues to grow stronger on the heels of this week’s overwhelming bipartisan 392-26 vote in the U.S. House. The latest to join the #Path2Cures is former Democratic Vice Presidential nominee, Virginia Senator Tim Kaine. A Kaine spokesperson told the Loudoun-Times Mirror, “Sen. Kaine will support the 21st Century Cures Act, bipartisan legislation which includes critically important funding for the National Institutes of Health, including the Cancer Moonshot Initiative.” The U.S. Senate is expected to vote to deliver #CuresNow early next week. [[{"fid":"1921","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"68","width":"307","class":"media-element file-full"}}]] Congresswoman Barbara Comstock (R-Va.-10th) is hailing the House of Representatives' passage of the 21st Century Cures Act, a sweeping piece of legislation Comstock frequently touted on the campaign trail this election season.

 The Cures bill, which passed Congress' lower chamber 392-26 on Wednesday, aims to speed up the Food and Drug Administration's review process for drugs and treatments, increase funding for cancer and other research at the National Institutes of Health and help fight the national opioid epidemic. The Senate will take up the proposal next week. 

 “The 21st Century Cures Act is a game changer in medical innovation in the fight for cures of chronic diseases,” Comstock, who won re-election in November, said in statement. “This legislation will help the United States lead the way in medical research and brings hope to patients with cancer, Alzheimer’s, diabetes, heart disease, and other conditions as we fight to find new cures.”

 The bill also includes intended enhancements to mental health care by creating new positions within Substance Abuse and Mental Health Services Administration.

 While popular, the Cures Act isn't without opposition, including from leaders of the Senate's liberal wing, Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.). …

 Despite those objections, the Cures Act is expected to pass in the upper chamber.

 A spokesperson for Sen. Tim Kaine (D) of Virginia said the senator will support the measure.

 "Sen. Kaine will support the 21st Century Cures Act, bipartisan legislation which includes critically important funding for the National Institutes of Health, including the Cancer Moonshot Initiative," Kaine spokesperson Sarah Peck said. "The bill also includes $1 billion in funding to combat the opioid abuse crisis and improve access to mental health care, which will have a tangible impact on the daily lives of Virginians in need."

 In Comstock's remarks, the congresswoman specifically pointed to two Leesburg families who lost children to cancer in recent years.

 “The Miller family, who lost their daughter Gabriella, and the Giordano family, who lost their son Mathias, have made it their mission to bring awareness and research dollars to the types of cancers that took their own children and this legislation is a big step forward for more resources to stamp out childhood cancers," she said.

 Comstock said the Cures bill includes $1.8 billion for cancer research over the next few years. That money will still have to doled out during appropriations.

 Sen. Mark Warner (D) of Virginia has not yet taken a public position on the latest Cures bill. Read the entire article online HERE. ### Read More

Look Ahead: Committee Announces Hearing Schedule for the Week of December 5

2016/12/02

[[{"fid":"1896","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"220","width":"339","class":"media-element file-full"}}]] WASHINGTON, DC – The House Committee on Energy and Commerce today announced its hearing schedule for the week of December 5. On Tuesday, the Subcommittee on Oversight and Investigations will hold a hearing to examine the investment commitments attached to the recently approved Partial Consent Decree in the Volkswagen “Clean Diesel” settlement. Members will examine the $2 billion investment Volkswagen is required to make in Zero Emission Vehicle (ZEV) infrastructure, as well as the $2.7 billion to be paid into the NOx Mitigation Trust. The Majority Memorandum and witness list are available here and witness testimony will be available at the same link as posted. On Wednesday, the Subcommittee on Health will hold a hearing to examine waste and duplication in the USDA Catfish Inspection Program. Members will examine the potential transfer of jurisdiction over catfish from a duplicative program at the USDA back to the FDA. The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. On Thursday, the Subcommittee on Commerce, Manufacturing, and Trade will hold a hearing to examine the fast-growing sport of Mixed Martial Arts (MMA). The hearing will give members an opportunity to examine the potential growth of the industry, the state regulations guiding it, and the health and safety of fans and participants. The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. Hearing Details Tuesday, December 6, 2016 10 AM 2322 Rayburn HOB Subcommittee on Oversight and Investigations Hearing on “Volkswagen’s Emissions Cheating Settlement: Questions Concerning ZEV Program Implementation” Wednesday, December 7, 2016 10 AM 2322 Rayburn HOB Subcommittee on Health Hearing on “Waste and Duplication in the USDA Catfish Inspection Program” Thursday, December 8, 2016 10 AM 2322 Rayburn HOB Subcommittee on Commerce, Manufacturing, and Trade Hearing on “Mixed Martial Arts: Issues and Perspectives” Read More

Upton & Bishop: EPA Releases Burdensome and Duplicative CERCLA Financial Assurance Rules

2016/12/02

WASHINGTON, DC – The Environmental Protection Agency (EPA) today released proposed requirements for risk management and financial assurance under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Energy and Commerce Committee Chairman Fred Upton (R-MI) and Natural Resources Committee Chairman Rob Bishop (R-UT) released the following statement: “The latest EPA proposed regulation is the result of sue-and-settle litigation that perpetuates more of the same special interest handouts from this administration. It’s a burdensome, duplicative, and completely unnecessary pile-on to the tune of billions of dollars on the backs of the mining industry. State financial assurance programs and numerous other federal regulations are already in place to ensure environmental stewardship, but the EPA ignored input from those models and stakeholders. This rule – drafted by EPA with very little input from states, the mining industry, and the financial sector - inevitably creates massive uncertainty and blocks access to our vast natural resources.” In August, Bishop and Upton sent a letter to EPA Administrator Gina McCarthy detailing their concerns about the increased costs, duplicative regulations, and lack of stakeholder input during the development of the rule. The Natural Resources Committee holds jurisdiction over laws that impact the hard rock mining industry and the Energy and Commerce Committee holds jurisdiction over CERCLA. ###  Read More

#ScottysStory: Calling for #CuresNow

2016/12/02

WASHINGTON, DC – As we’ve seen this week during the House’s consideration of the 21st Century Cures Act, the fight for #CuresNow is personal for many. That includes Rep. Jeff Denham (R-CA) and his friend Scotty Whitecotton. Scotty has Hunter syndrome and has been incredibly active on the #Path2Cures. The Mayo Clinic describes hunter syndrome as “a very rare, inherited genetic disorder caused by a missing or malfunctioning enzyme. Because the body doesn’t have enough of the enzyme to break down certain complex molecules, the molecules build up in harmful amounts.” Over time, the build up causes permanent changes to one’s physical appearance, mental development, organ function, and physical abilities. Rep. Denham has helped raise awareness of Hunter syndrome, Scotty’s own story, and 21st Century Cures – most noticeably on Scotty’s birthday each year. [[{"fid":"1880","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"233","width":"468","class":"media-element file-full"}}]] From left to right: Scotty gets special birthday messages. In 2015, the birthday message came from House Majority Leader Kevin McCarthy (R-CA). This year, the birthday message came from House Speaker Paul D. Ryan (R-WI). Today, those efforts continue with a Facebook Live event discussing how 21st Century Cures will help the rare disease community. Scotty’s uncle had Hunter syndrome and passed away at the age of 12. Today at 19, Scotty is hoping #CuresNow will help find more treatments – or even a cure – to extend his life. [[{"fid":"1882","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"394","width":"470","class":"media-element file-full"}}]] Tune in to Rep. Denham’s Facebook Live event HERE. To learn more about the 21st Century Cures Act, click HERE. ###  Read More

INSTA-GRAB: #BehindTheScenes with Fred Upton

2016/12/02

On Wednesday, Chairman Fred Upton (R-MI) (@repfredupton) became the most recent member to take over the Energy and Commerce Committee’s Instagram account. His day started with bright lights and a microphone, joining House Speaker Paul Ryan and the GOP leadership as well as Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) for a press conference on #CuresNow. The day ended with another press conference following the overwhelming 392-26 vote in support of the innovation game-changer. Scroll down for a digital recap of Chairman Upton’s day, and be sure to follow @energyandcommerce for more photos. [[{"fid":"1873","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"447","width":"596","class":"media-element file-full"}}]] Joined @housegop leaders here in the House to discuss #CuresNow and why it’s so important to patients across the country. We will be voting on this legislation later today! Learn more: energycommerce.house.gov/cures Instagram [[{"fid":"1874","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"386","width":"591","class":"media-element file-full"}}]] Making a few press calls ahead of today’s big #CuresNow vote! #BehindTheScenes Instagram [[{"fid":"1875","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"444","width":"596","class":"media-element file-full"}}]] BREAKING: #CuresNow just passed the House 392-26! Instagram [[{"fid":"1876","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"399","width":"593","class":"media-element file-full"}}]] This moment was 3 years in the making #CuresNow #GameChanger. Thanks for following along today during my Instagram and the #Path2Cures. We will deliver #CuresNow. 392-26!! Instagram *BONUS* [[{"fid":"1877","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"591","width":"593","class":"media-element file-full"}}]] Be sure to check out these four fast facts from Chairman Upton. Instagram Thank you to Chairman Upton for sharing his #DayInTheLife with E&C followers! Stayed tuned for who our next special guest will be and follow @energyandcommerce on Instagram for more #behindthescenes photos. Read More

#CuresIn4Words: Faster Treatments for Patients

2016/12/02

Fresh off the heels of the House’s overwhelmingly bipartisan vote on the 21st Century Cures Act, The Wall Street Journal’s Opinion Journal profiled the game-changing legislation. Manhattan Institute Senior Fellow Paul Howard said of the bill, “it’s a big win for patients…it moves the drug development process into the 21st century, gives the FDA, innovators, researchers, a lot of new tools for delivering customized cures for patients based on their genetics or other information that can get drugs to patients at a fraction of the time…” To learn more about 21st Century Cures, click here. [[{"fid":"1867","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"52","width":"156","class":"media-element file-full"}}]] December 1, 2016 Opinion Journal: Speeding Up Drug Discovery [[{"fid":"1868","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"264","width":"468","class":"media-element file-full"}}]] Watch the video HERE. ### Read More

Upton on Selection of Greg Walden as Next Energy and Commerce Committee Chairman

2016/12/01

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) today issued the following statement congratulating Energy and Commerce Committee Chairman-elect Rep. Greg Walden (R-OR). Rep. Walden will take over the committee in the 115th Congress. “Like the Chicago Cubs, we are a team full of MVPs and Energy and Commerce will be in great hands with my friend Greg Walden holding the gavel. Greg’s leadership with #SubCommTech demonstrated his hard work and proven record of success,” said Upton. “We’ve got a lot to do in the remaining days of this Congress, including getting 21st Century Cures across the finish line. As we look toward a new year, a new Congress, and a new administration, the Energy and Commerce Committee will be leading the way on health reform, keeping energy affordable, and putting folks back to work. House Republicans have a better way, and I look forward to Greg Walden’s leadership in the 115th Congress.” ###  Read More

Blackburn Statement on House Passage of Resolution to Ensure Select Panel Completes its Work

2016/12/01

Washington, DC — Chairman Marsha Blackburn (R-TN) issued the following statement on House passage of H. Res. 933, to authorize funding necessary to allow the Select Investigative Panel to complete its inquiry into America’s abortion industry and fetal tissue procurement entities:   “Our Panel was tasked with investigating areas that, prior to the revelations of undercover journalists, received too little attention. For most of us, it is nothing short of an outrage that Planned Parenthood and other abortion clinics supplement their budgets by selling human fetal tissue from aborted babies. The House charged members of this Panel with investigating fetal tissue trafficking, second- and third-trimester abortion practices, the standard of care for infants who survive abortions, and the role played by our taxpayer dollars in this sector of society. Over the last year, we have held hearings that explored the bioethics surrounding fetal tissue use and that revealed the sobering reality of how some bad actors seek to profit from the sale of fetal tissue in violation of federal law. “The work of our Panel is specifically focused on protecting the integrity of research, scientific advancements, and voluntary organ donation in America. Evidence we have uncovered reveals that the unethical and potentially unlawful practices of some bad actors may be putting important research at risk. Considering all that our Panel has identified, despite having barely a year to conduct this investigation, it is now up to us to build on this work, to hold our government accountable, and to stop these affronts to human dignity.” ### Read More

#SubCMT to Hold Hearing on Mixed Martial Arts NEXT WEEK

2016/12/01

The Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Michael C. Burgess, M.D. (R-TX), has scheduled a hearing for Thursday, December 8, at 10 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, "Mixed Martial Arts: Issues and Perspectives." Mixed Martial Arts (MMA) is one of the fastest growing and rapidly evolving sports in the world. As this sport continues to increase in its popularity here at home, this hearing will provide members with an opportunity to learn about the industry including its potential growth; the state-level rules and regulations guiding the industry; the complex interrelationships between fighters, promoters, regulators, and sponsors; and health and safety protections for fans and fighters. The committee will hear from a variety of stakeholders representing different perspectives from this industry. “Over the last several decades, we’ve seen mixed martial arts transform into a mainstream sport with a devoted fan base and enormous growth in corporate sponsorships, merchandise, and marketing of athletes and events,” said Burgess. “Next week’s hearing will provide an opportunity to examine the sport and discuss the policy issues it raises as well.” The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted. Read More

Massachusetts Advocates Rally Behind #CuresNow

2016/12/01

Last night, the innovation game-changer 21st Century Cures Act overwhelmingly passed the House of Representatives 392-26. The wide bipartisan vote would not have been possible without the strong support of energized advocates in the patient and research communities across the nation. Massachusetts advocates support has been particularly unwavering, recognizing the importance of delivering #CuresNow to patients. MassBio CEO Bob Coughlin told Boston Business Journal, “This legislation will be very good for the economy in the commonwealth of Massachusetts, and more importantly, very good for patients around the world… The 21st Cures Act was 100 percent written in a way to promote innovation to create cures.” As consensus continues to builds behind the landmark package to deliver hope to millions of patients and families affected by disease, advocates on the #Path2Cures are focusing in on the last remaining obstacles. After declaring her opposition to the “innovation game-changer” earlier this week, one-time contributor to 21st Century Cures, Senator Elizabeth Warren (D-MA), is hearing from a growing coalition of biotech, medical device, and research advocates back home in Massachusetts about why she needs to get back on the #Path2Cures. Patients are sick of partisan politics, and Wednesday’s 392-26 vote offers hope that when it comes to #CuresNow, their representatives will do the right thing. To learn more about 21st Century Cures, click here. [[{"fid":"1860","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"82","width":"427","class":"media-element file-full"}}]] December 1, 2016 Activists urge Warren to support health care bill Advocates for addiction treatment in Massachusetts on Wednesday launched a campaign to persuade Senator Elizabeth Warren to reverse her opposition to a bill known as the 21st Century Cures Act, saying the state needs money for addiction treatment that the legislation could provide. Warren, who worked on the bill for two years and wrote parts of it, turned against it Monday, saying it had been rewritten to benefit pharmaceutical companies at the expense of consumers. The bill, which passed the House on Wednesday evening, is intended to promote cancer research and other biomedical research, and includes $1 billion to combat the opioid crisis. Vic DiGravio, president of the Association for Behavioral Healthcare, a trade group of mental health and addiction treatment organizations in Massachusetts, e-mailed an “action alert” Wednesday morning to 3,600 people, including treatment professionals, activists, people in recovery, and relatives of addicts. The letter urges people to call Warren’s office to say “Massachusetts desperately needs” the money to fight the epidemic of opioid abuse. … Read the full article online HERE. [[{"fid":"1861","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"86","width":"319","class":"media-element file-full"}}]] November 30, 2016 With backing of Mass. trade groups, House passes 21st Century Cures bill The state's biotech and medical device trade groups are standing firm behind the controversial 21st Century Cures Act, arguing the bill — which passed in the U.S. House of Representatives on Wednesday night — will give more access to potentially groundbreaking new treatments without compromising safety. The House voted 392-26 to pass the bill, sending it to the Senate. The White House issued a statement Wednesday evening saying that it supports the measure. MassBio CEO Bob Coughlin says the 21st Century Cures Act "will be very good for the economy in the Commonwealth of Massachusetts." The legislation provides the NIH with $4.8 billion over 10 years for research programs, including Vice President Joe Biden’s cancer moonshot; gives states $1 billion to combat the opioid crisis; and provides the FDA with $500 million in funding. … “This legislation will be very good for the economy in the commonwealth of Massachusetts, and more importantly, very good for patients around the world,” Coughlin said. “The 21st Cures Act was 100 percent written in a way to promote innovation to create cures.” Read the full article online HERE. Read More

Headlines On the #Path2Cures

2016/12/01

AP: House Oks Bill Bolstering Medical Research, Drug Approvals CNN: Bipartisanship Lives! House Passes Cancer Research Bill CNBC/REUTERS: US House Passes 21st Century Cures Health Bill FORTUNE: House Just Passed the Biggest Health Reform Bill Since Obamacare THE NEW YORK TIMES: House Overwhelmingly Approves Sweeping Health Measure ROLL CALL: ’Cures’ Research Package Draws Strong Bipartisan Vote STAT: House Approves the 21st Century Cures Act, Sending Landmark Bill to Senate THE HILL: House Passes Medical Cures Bill USA TODAY: House Passes Sweeping Health Innovation Bill with $1 Billion for Opioids THE WALL STREET JOURNAL: House Passes Health Bill to Speed Drug Approvals, Boost Biomedical Research WASHINGTON EXAMINER: House Passes Cures Bill with Mental Health Reforms Included THE WASHINGTON POST: House Overwhelmingly Passes ‘Cures’ Legislation to Streamline Drug Approval THE WASHINGTON TIMES: House Passes 21st Century Cures Bill, Funding Medical Research and Fighting Drug Epidemic ### Read More

Landmark Mental Health Reforms Head to Senate

2016/11/30

WASHINGTON, DC – The U.S. House of Representatives today approved the 21st Century Cures Act by a vote of 392-26. Included in the bill were mental health reforms spearheaded by Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), which were based largely off his bill, H.R. 2646, the Helping Families in Mental Health Crisis Act. “With the House’s strong support of these critical reforms, we’re one step closer to delivering meaningful reforms to families in mental health crisis,” said full committee Chairman Fred Upton (R-MI) and Chairman Murphy. “We have worked to reduce stigma around this important issue, and let folks know it’s okay to ask for help. Throughout our multi-year, multi-Congress effort to advance solutions to a broken system, we’ve raised awareness and helped identify ways to help those around us. These reforms have been a long time coming and we look forward to the Senate quickly following in our footsteps.” For more information on the full package that passed the House today, click HERE. ###  Read More

BREAKING: Game-Changer #CuresNow Passes House

2016/11/30

WASHINGTON, DC – The U.S. House of Representatives today approved the 21st Century Cures Act by a vote of 392-26. “With today’s overwhelming bipartisan vote, we took a giant leap forward on the #Path2Cures,” said Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), co-authors of the bill. “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need. The White House has expressed its enthusiastic endorsement of this critical legislation. So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.” For more information about the 21st Century Cures Act, click here.  ###  Read More

Momentum Continues to Build for #CuresNow

2016/11/30

[[{"fid":"1859","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"513","width":"679","class":"media-element file-full"}}]] WASHINGTON, DC – As today’s vote nears on the 21st Century Cures Act, support continues to build. The growing support is diverse, coming from: patient advocacy groups, rare disease groups, cancer centers, technology groups, top universities, biopharmaceutical companies, medical device companies, and others. To date, over 300 groups, some representing anywhere from 50 to 200 organizations, have shared letters or messages of support. A list of the 300+ groups is below: A Kids’ Brain Tumor Cure A New PATH Abby Grace Foundation Academy of Managed Care Pharmacy ACT for NIH Ad Hoc Group for Medical Research Addiction Policy Forum Adrenal Insufficiency United AdvaMed    Advocates for Recovery Colorado Air Conditioning Contractors of America Alano Club of Portland Allergy & Asthma Network Alliance for Aging Research Alliance for Biosecurity Alliance for Dedicated Cancer Centers Alpha-1 Foundation Alzheimer’s Association American Academy of Adoption Attorneys (AAAA) American Association for Dental Research American Association of Colleges of Pharmacy American Academy of Dermatology American Academy of Family Physicians American Academy of Pediatrics American Art Therapy Association American Association for Cancer Research American Association of Colleges of Pharmacy American Association for Geriatric Psychiatry American Association for Marriage and Family Therapy American Association for the Study of Liver Diseases American Association of Immunologists American Association of Neurological Surgeons/Congress of Neurological Surgeons American Cancer Society Cancer Action Network, Inc. American Childhood Cancer Organization American Congress of Obstetricians and Gynecologists American College of Emergency Physicians American College of Gastroenterology American College of Radiology (ACR) American Dance Therapy Association American Foundation for Suicide Prevention American Gastroenterological Association American Group Psychotherapy Association American Hospital Association’s (AHA) American Liver Foundation American Nurses Association American Occupational Therapy Association American Psychiatric Association American Psychological Association American Society for Gastrointestinal Endoscopy American Society for Radiation Oncology American Society of Clinical Oncology (ASCO) Americans for Tax Reform Anxiety and Depression Association of America Asbestos Disease Awareness Organization Associated General Contractors Association for Ambulatory Behavioral Healthcare Association for Behavioral Health and Wellness Association of American Cancer Institutes Association of American Medical Colleges Association of American Universities (AAU) Association of American Veterinary Medical Colleges Association of Persons Affected by Addiction (APAA) Association of Public and Land-grant Universities (APLU) Association of Recovery Schools Autism Speaks Auto Care Association Bangor Area Recovery Network, Inc. Big Cities Health Coalition Beyond Celiac Blue Faery: The Adrienne Wilson Liver Cancer Association Blue Ribbon Study Panel on Biodefense Boston Scientific Brain Injury Association of America California Consortium of Addiction Programs & Professionals California Life Sciences Association Capital Area Project Vox Catholic Health Association Caron Treatment Centers Center for Clinical Social Work Center for Recovery and Wellness Resources Central Pain Syndrome Foundation Chicago Recovering Communities Coalition (CRCC) City of Hope Coalition for CLIA Waiver Reform Coalition for the Life Sciences Coalition for Pediatric Medical Research Coalition of Cancer Cooperative Groups Coalition to Stop Opioid Overdose Communities for Recovery Community Anti-Drug Coalitions of America (CADCA) Connecticut Community for Addiction Recovery (CCAR) Cord Blood Association Consumer Health Care Products Association Corning Incorporated Council for Affordable Health Care Coverage Council of State Government Justice Center Coalition Cure JM Foundation Cure Sanfilippo Foundation DarJune Recovery Support Services & Café DaVita Inc. DC Recovery Community Alliance Deadliest Cancers Coalition DeBartolo Family Personalized Medicine Institute at the Moffitt Cancer Center Debbie's Dream Foundation: Curing Stomach Cancer Depression and Bipolar Support Alliance Detroit Recovery Project, Inc. Digestive Disease National Coalition Dorchester Recovery Initiative Dysautonomia International Drew’s Hope Easy Does It, Inc. Eating Disorders Coalition El Paso Alliance Emergency Nurses Association Engaged Recovery Community Services Epilepsy Foundation Esophageal Cancer Action Network EveryLife Foundation for Rare Diseases Faces & Voices of Recovery FasterCures, A Center of the Milken Institute FAVOR Greenville FAVOR Mississippi Recovery Advocacy Project FAVOR Pee Dee FAVOR Tri-County Fellowship Foundation Recovery Community Organization Fight Colorectal Cancer Floridians for Recovery Foundation for Recovery Friends of Cancer Research Friends of Recovery - New York Gem County Recovery Community Center Georgia Council on Substance Abuse Global Cold Chain Alliance Global Genes GPhA Greater Macomb Project Vox GW Cancer Center Health IT Now Heating, Air-conditioning & Refrigeration Distributors International Hepatitis B Foundation Hepatitis Foundation International HOPE for New Hampshire Recovery Huntington's Disease Society of America Hydrocephalus Association ICAN, International Cancer Advocacy Network Illinois Association for Behavioral Health Immune Deficiency Foundation Indivior, Inc. Infectious Diseases Society of America Intel International Certification & Reciprocity Consortium International Community Corrections Association International Franchise Association International Myeloma Foundation Jackson Area Recovery Community JDRF John Wiley & Sons Juneau Recovery Community Kidney Cancer Association Kidney Care Council Kids v Cancer Klippel-Feil Syndrome Freedom Latah Recovery Center LexisNexis Leukemia & Lymphoma Society Lifehouse Recovery Connection Long Island Recovery Association (LIRA) Lost Dreams Awaken Center, Inc. Lotus Peer Recovery/SoberKerrville Lung Cancer Alliance LUNGevity Lupus and Allied Diseases Association Lupus Foundation of Northern California Lustgarten Foundation for Pancreatic Cancer Research Lymphoma Research Foundation Maine Alliance for Addiction Recovery March of Dimes Maryland Recovery Organization Connecting Communities (M-ROCC) Massachusetts Organization for Addiction Recovery (MOAR) Mayo Clinic MD Anderson Cancer Center Medical Imaging & Technology Alliance Medical Device Manufacturers Association (MDMA) Melanoma Research Alliance Memorial Sloan Kettering Cancer Center Mental Health America Mental Health Liaison Group Mesothelioma Applied Research Foundation Message Carriers of Pennsylvania, Inc. Michigan Recovery Voices Microbion Corporation Mid-America Lumbermans Association Mid-Atlantic Region for Tomorrow (SMART) Mi-HOPE - Michigan Heroin & Opiate Prevention and Education Milken Institute Minnesota Recovery Connection Missouri Recovery Network MLD Foundation National Alliance for Eye and Vision Research (NAEVR)/Alliance for Eye and Vision Research (AEVR) National Alliance on Mental Illness (NAMI) National Alliance to Advance Adolescent Health National Association for Children of Alcoholics National Association for Children’s Behavioral Health National Association for the Self-Employed National Association of County and City Health Officials National Association of Addiction Treatment Providers National Association of Elder Law Attorneys National Association of Home Builders National Association of Mental Health Program Directors (NASMHPD) National Association of State Head Injury Administrators National Association of the Remodeling Industry National Association of Towns and Townships National Association of Wholesaler-Distributors National Brain Tumor Society National Coalition on Health Care National Council for Behavioral Health National Federation for Independent Business National Fragile X Foundation National Grange National Health Care for the Homeless Council National Health Council National Hispanic Medical Association National League for Nursing National MPS Society National Multiple Sclerosis Society National Organization for Rare Disorders National Ovarian Cancer Coalition National Pancreas Foundation National Patient Advocate Foundation National Psoriasis Foundation National Restaurant Association National Retail Federation National Small Business Association National Stroke Association Natural Products Association Navigate Recovery Newport Brain Research Laboratory No Health without Mental Health Noah's Hope - Hope4Bridget North Carolina State Grange Northern Ohio Recovery Association (NORA) Oklahoma Citizen Advocates for Recovery & Treatment Association (OCARTA) Oncology Nursing Society Orthopedic Research Society Ovarian Cancer Research Fund Alliance P.E.E.R Wellness Center, Inc. Padgett Business Services Pancreatic Cancer Action Network Parity Implementation Coalition PEER360 Recovery Alliance Penn State University Pennsylvania Recovery Organization - Achieving Community Together - (PROACT) Pennsylvania Recovery Organizations Alliance (PRO-A) Pennsylvania State Grange People Advocating Recovery – PAR Physician Clinical Registry Coalition PLR Athens Police Foundation Premier Prevent Cancer Foundation Prostate Cancer Foundation Rare Disease United Foundation RASE Project RASopathies Network REAL-Michigan (Recovery, Education, Advocacy & Leadership) Recover Project/Western MA Training Recover Wyoming Recovery - Friendly Taos County Recovery Allies Of West Michigan Recovery Communities of North Carolina Recovery Community Of Durham Recovery Consultants of Atlanta Recovery Idaho, Inc. Recovery is Happening RecoveryATX RecoveryNC (Governors Institute on Substance Abuse) reGROUP Research!America Retail Industry Leaders Association (RILA) Roswell Park Cancer Institute Rhode Island Communities for Addiction Recovery Efforts (RICAREs) Samsung Electronics America, Inc. Sandy Hook Promise Sarcoma Foundation of America Saturation Mailers Coalition Schizophrenia and Related Disorders Alliance of America School Social Work Association of America Seattle Cancer Care Alliance Select Medical Shatterproof Small Business and Entrepreneurship Council SMART Recovery Society for Immunotherapy of Cancer Society of Infectious Diseases Pharmacist Society of American Florists Society of Gynecologic Oncology Society of Hospital Medicine Solano Recovery Project Spina Bifida Association Springs Recovery Connection State and Criminal Justice Groups T.O.R.C.H Inc. TargetCancer Foundation The ALS Association The Bridge Foundation The Chicago Medicine and The Clinical Social Work Association The DOOR - DeKalb Open Opportunity for Recovery The Jewish Federations of North America The Kortney Rose Foundation The McShin Foundation The Mended Hearts, Inc The Michael J. Fox Foundation The Moyer Foundation The National Center on Addiction and Substance Abuse The National Register of Health Service Psychologists The Partnership for Drug-Free Kids The Police Foundation The Rare and Undiagnosed Network (RUN) The Trevor Project Thermo Fisher Scientific Tia Hart Recovery Community Program Tourette Association of America Treatment Alternatives for Safe Communities (TASC), Inc. Treatment Communities of America Trilogy Recovery Community Trinity Health, Livonia MI Trust for America's Health Tulane University United for Medical Research (UMR) University City Science Center University of Chicago Medicine University of Southern California (USC) University of Wisconsin-Madison Utah Support Advocates for Recovery Awareness (USARA) V Foundation for Cancer Research Vanderbilt University Vermont Recovery Network Virginia Association of Recovery Residences Voices of Hope for Cecil County Voices of Recovery San Mateo County Vizient, Inc. WAI-IAM, Inc. and RISE Recovery Community Washtenaw Recovery Advocacy Project (WRAP) WEX Health Weill Cornell Medicine WholeLife Recovery Community/ Arizona Recovery Coalition Wisconsin Recovery Community Organization (WIRCO) Wisconsin Voices for Recovery Young People in Recovery and Facing Addiction Zane Benefits Zero to Three For more information on 21st Century Cures, click HERE. ###  Read More

NEW YORK DAILY NEWS: #CuresNow Is “Timely Medicine”

2016/11/30

A monumental vote on the 21st Century Cures Act is just hours away, and the New York Daily News added its voice to get #CuresNow across the finish line. Praising the bipartisan hard work of committee leaders, the editorial board highlights a “promising legislative package,” saying that Congress “is on the verge of doing something big.” To learn more about 21st Century Cures, click here. [[{"fid":"1855","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"108","width":"1108","style":"width: 400px; height: 58px;","class":"media-element file-full"}}]] November 30, 2016 EDITORIAL: A better pill to swallow with Congress adding to health funding The do-nothing Congress is on the verge of doing something big: boosting by billions federal support for medical research, while prying drug and device testing free of needless constraints on innovation. That the 21st Century Cures Act now also includes crucial measures to speed psychological treatment to the most seriously sick, steadfastly advanced by Rep. Tim Murphy (R-Pa.), gives the House of Representatives all the more reason to pass this promising legislative package in a vote expected Wednesday. An important part of the bill — championed by Michigan’s Fred Upton in the House and Tennessee Sen. Lamar Alexander — would move the U.S. from the 20th century era of one-size-fits-all pharmaceutical testing, rigidly categorized by medical condition, to a more flexible model in which drug developers — a disproportionate share of whom are here in research-rich New York — can target treatments to subsets of patients biologically predisposed to respond to them. A $4.8 billion boost to the National Institutes of Health encompasses the cancer-research “moonshot” sought by Vice President Joe Biden in memory of his late son Beau, backing for research into brain afflictions such as Alzheimer’s and research into the genetic and environmental factors driving disease. Another $1 billion would help states combat the scourge of opioid abuse. The Food and Drug Administration, which tests and okays treatments, would get funding enabling it to hire the best talent to oversee the expected flourishing of sophisticated medical trials. The mental health provisions could prove a godsend to families struggling to care for severely mentally ill loved ones, by giving them greater access to their treatment plans and expanding use of court-ordered assisted outpatient treatment for those who pose a danger to themselves or others, known in New York as Kendra’s Law. For a Congress that’s frequently infected by a partisan aversion to government spending, even when that spending will alleviate suffering, this bill is timely medicine. Among the House members casting a vote will be Dr. Tom Price, nominee to be next secretary of Health and Human Services, overseeing both the NIH and FDA. Should the Cures Act become law, Price will have the heady responsibility of making more and more life-saving advances go from the research bench to medicine cabinet. Read the full editorial online HERE. Read More

#SubHealth Examines U.S. Preventive Services Task Force

2016/11/30

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joseph Pitts (R-PA), today held a hearing examining the United States Preventive Services Task Force (USPSTF). The USPSTF was created in 1984 as an independent, volunteer panel aimed at making clinical preventive services recommendations, which could work to improve the health of all Americans. The Affordable Care Act required the USPSTF to submit annual reports to Congress with recommendations to generate new knowledge, address health priorities, and improve preventive care. Unfortunately, these recommendations are not living up to their intended purpose. Full committee Vice Chairman Marsha Blackburn (R-TN) and committee member Rep. Bobby Rush (D-IL) have introduced a discussion draft aimed at alleviating the problems at USPSTF, entitled “USPSTF Transparency and Accountability Act of 2016,” which would: Require specialists and subspecialists to be involved in reviewing the preventive services examined by the Preventive Services Task Force, Allow a wide range of patient groups, providers and federal agencies to be involved in the important review process of preventive services, and; Provide greater transparency by requiring any evidence and recommendations be made available for public comment. [[{"fid":"1857","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"508","width":"783","style":"width: 650px; height: 422px;","class":"media-element file-full"}}]] “There continues to be growing concerns over a number of the USPSTF recommendations – and the attempt to control cost by limiting patient access to preventive care,” said Rep. Blackburn. “It is important that we reform this flawed system and ensure informed patient-centered choices for individual health needs. Congress has an oversight responsibility and today’s hearing helped us better understand the implications of these recommendations, and their impact on coverage.” [[{"fid":"1858","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"583","width":"767","style":"width: 650px; height: 494px;","class":"media-element file-full"}}]] John H. Lynch, Chairman and Professor at the Department of Urology at Georgetown University issued his support for the discussion draft, stating, “We hope that Congress will enact the ‘USPSTF Transparency and Accountability Act’ so that key improvements in transparency and accountability for the Task Force’s process determining coverage and access will assist patients in receiving preventive care.” Chairman Pitts concluded, “Experience has shown that a number of the Task Force recommendations have the effect of limiting access to preventative care. Such recommendations contradict clinical guidelines based on medical literature and experts in the field. The concerns are that these recommendations could undermine new models of care delivery. Today’s hearing provided us a good overview of the work conducted by the Task Force and how it might be improved with passage of this legislation.” For more information on today’s hearing including a background memo, witness testimony, and an archived webcast click HERE. Read More

Upton Kicks Off Debate on #CuresNow

2016/11/30

[[{"fid":"1856","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"260","width":"468","class":"media-element file-full"}}]] Watch the video HERE. (Remarks as prepared for delivery) There is not a single person in this chamber or watching at home today who has not been touched by disease in some way. We have all said too many early good-byes to people we hold dear. Families robbed of a parent that will never get to see their child’s milestones. A child born without the gift of a future. Every day, countless folks living vibrant lives are delivered unexpected diagnoses. It’s a cycle that repeats itself over and over in every community. Life changes in an instant – and hope seems just out of reach. Whether it be Alzheimer’s, Lupus, MS, cancer…you name it. No matter where you’re from – one thing that binds us all together is we all want more time with loved ones. That’s why we’re here today – because the clock is ticking for patients and their families. Which brings us to 21st Century Cures. This bipartisan legislation will ensure our health system can keep pace with incredible advances in science and technology. In “Cures” - we’ve got a medical innovation game-changer that will deliver hope to patients across America. We have been here before. In July 2015, after a series of roundtables, hearings, whitepapers, and public feedback, the House overwhelmingly voted in support of 21st Century Cures. Sure, we have encountered a number of detours and obstacles along this path to cures, but we have taken great inspiration in those patients who have partnered in this effort to persevere, stay positive, and continue forward to get the job done. Just like my two little Michigan angels – Brooke and Brielle – who are battling SMA, do every day. Each day they muster incredible strength and courage, conquering challenges that most folks will never encounter in a lifetime. So….three years ago we had an idea. That we could do better. We needed to do something and transform our health and research system to effectively fight disease in the 21st century. Finding cures and boosting research and innovation was absent from any policy to-do list. People did not seem to care that the gap between biomedical innovation and our regulatory process was widening. Or that of the 10,000 known diseases – 7,000 of which are rare – there are treatments for only 500. We needed to change the conversation and restore urgency. And working together, we have.  But first, we listened. To more than just Brooke and Brielle. But to the Barb’s and Becky’s and Lisa’s. Geno, the Don’s, the Betsy’s….Little Max. Virtually everyone. Science and biomedical innovation have made incredible strides over the last two decades. Mapping the human genome, new biomarkers, and personal health care apps have all offered new opportunities to find new treatments and cures. But the way the FDA and NIH apply these new innovations to our regulatory process has lagged behind. These agencies – and the rules and regulations they produce affecting the discovery, development, and delivery of life saving drugs and devices – also desperately need modernization and innovation. They need a game-changer. And we have it. This legislation breaks down regulatory barriers and expedites the approvals for drugs and devices coupled with billions for more research. The former head of The National Cancer Institute and FDA, Andy Von Eschenbach, has called this “the most transformational biomedical legislation in the past 40 years.” He’s right. But this package is not just about Cures. It also achieves several additional topline priorities for the Energy and Commerce Committee, including valuable resources to fight the opioid epidemic, and delivering landmark mental health reforms spearheaded by Dr.  Tim Murphy to help families in crisis and treat mental illness rather than incarceration. This is without a doubt the most important and impactful bill we will enact this Congress. Patients aren’t interested in debating the timelines, the failure rates, the size and the costs of conducting clinical trials are at all-time highs. They just know that despite the promise of scientific breakthroughs, they can’t get the therapy that might save their life. That is why we need 21st Century Cures. I want to give a special thanks for my many partners….Especially Diana DeGette. Not to mention Joe Pitts, Frank Pallone, Tim Murphy, Lamar Alexander….Leadership on both sides of the aisle in both chambers. My simply brilliant committee and personal office teams lead by Gary Andres and Joan Hillebrands, Health Counsel Paul Edattel. And of course my wife Amey. We are on the cusp of something special. A once-in-a-generation opportunity to transform how we treat disease. With today’s vote, we are taking a giant leap on the Path to Cures. Working together, we will deliver Cures Now. ###   Read More

E&C Leaders Comment on EPA’s Proposed Emissions Standards

2016/11/30

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI), Commerce, Manufacturing, and Trade Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Energy and Power Subcommittee Vice Chairman Pete Olson (R-TX) today issued the following statement after the Environmental Protection Agency released its proposed emissions targets for model years 2022-2025. “This action is completely unnecessary and will have grave consequences on jobs and manufacturing. Under EPA’s own regulations this determination is not required for another year and a half, but with the clock ticking on the administration, the regulatory frenzy is underway. Federal regulations should not stand in the way of the car-buying public having their choice of vehicles at prices they can afford,” said Upton, Burgess, and Olson. The leaders continued, “The mid-term review was previously established to allow government to move forward with the most up to date information available. Instead, these complicated and onerous standards were rushed through at the 11th hour without taking into consideration their complexity, impact on consumer’s pocketbooks, the impact on the auto industry and jobs, innovation, and changes occurring in the marketplace, including the cost of new safety technologies. Motor vehicles are becoming increasingly more efficient and will continue to do so. For the sake of car makers and buyers, and commonsense, we will continue our oversight of these proposed standards moving forward.” ###  Read More

Examining the United States Preventive Services Task Force

2016/11/30

[[{"fid":"1854","view_mode":"full","fields":{"format":"full"},"type":"media","attributes":{"alt":"Examining the United States Preventive Services Task Force","height":"380","width":"640","class":"media-element file-full"},"link_text":null}]] Read More

VIDEO: What Makes #CuresNow an Innovation Game-Changer

2016/11/30

From the mapping of the human genome to the rise of personalized medicines that are linked to advances in molecular medicine, we have seen constant breakthroughs that are changing the face of disease treatment, management, and cures. Health care innovation is happening all around us. But if our laws and agencies don’t keep up, patients lose. [[{"fid":"1850","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"313","width":"547","class":"media-element file-full"}}]] Watch the video HERE. 21st Century Cures will safely accelerate the critical cycle of discovering, developing, and delivering new cures and treatments. We can close the gaps between advances in scientific knowledge about cures and outdated regulatory policies. This legislation is an innovation game-changer. By accelerating that critical process, we can deliver hope to patients everywhere, while ensuring America remains the global leader in biomedical innovation. To put it simply, 21st Century Cures is a once-in-a-generation opportunity to help researchers change the way we fight disease. Want more information? Click HERE to read a quick breakdown, or click HERE to read the section by section. Read More

#CuresIn4Words: Back in the House

2016/11/30

Ahead of today’s vote on the 21st Century Cures Act, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) took to Morning Consult to highlight their bipartisan #Path2Cures. “This bill is for those battling disease yesterday, today, and tomorrow, delivering more hope and more time to patients and their loved ones,” wrote Upton and DeGette, original cosponsors of the multi-year effort. “…Together, we will change the way we fight disease and help deliver #CuresNow.” [[{"fid":"1851","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"52","width":"311","class":"media-element file-full"}}]] November 30, 2016 It’s Time to Deliver #CuresNow By Chairman Fred Upton and Rep. Diana DeGette Three years ago, we agreed that our country needed to transform its health and research system to fight disease effectively in the 21st century. Patients deserved better. We could do better. Every single American has been touched by disease in some fashion, whether directly or indirectly, and the toll is painfully all too familiar. But from the rarest diseases to the more common, there is a reason for all to have hope this year. While bipartisan collaboration has been less than abundant in Washington recently, it has been the driving force for us, a Republican from Michigan and a Democrat from Colorado. We came up with the 21st Century Cures Act, an innovation game-changer providing a way to safely speed the discovery, development and delivery of new treatments and cures. We are united on the #Path2Cures in the belief that the country needs and is ready for a renewed effort to support biomedical research and harness innovation to turn discoveries in the lab into outcomes that change patients’ lives. Our open and collaborative process led to groundbreaking ideas. It was a comprehensive effort that criss-crossed the country, engaging experts in every related field, from academia to government to private industry and everything in between. And most importantly, we listened to patients. Our efforts have culminated in legislation that will provide necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments: H.R. 34, the 21st Century Cures Act. This transformational bill will bring our health infrastructure lightyears ahead to best match the incredible breakthroughs that are happening by the day. The bill provides a once-in-a-generation opportunity to help researchers change the way we fight disease by catalyzing cutting-edge research, modernizing clinical trials, and improving the medical device review process. The 21st Century Cures Act invests $4.8 billion in new resources for a medical research innovation fund at the National Institutes of Health that will target diseases for which there is not yet a cure. It also supports the Food and Drug Administration with new resources to keep pace with medical innovation, including new drugs and devices that need expert review. This bill also brings the patient perspective to the heart of research and development, and seeks to foster better use of personalized medicine and more participation in clinical trials. This bill also funds Vice President Joe Biden’s cancer moonshot initiative — putting the universal goals of learning more about cancers, how to detect them, how to treat them, and beyond, well within our grasp. Labeled by Senate Majority Leader Mitch McConnell (R-Ky) as “the most significant piece of legislation we pass in the whole Congress,” we have a once-in-a-generation opportunity to dramatically change the way we treat disease. The American people expect Congress to come together on matters that can improve lives. The 21st Century Cures Act is a rare act of bipartisanship that can fulfill that promise. We have long said that together we can achieve this goal. We are on the cusp of something special. Today the House will vote on the bipartisan agreement recently reached by our colleagues. The Senate is expected to quickly follow suit. From there, we just need President Barack Obama’s signature. This bill is for those battling disease yesterday, today, and tomorrow, delivering more hope and more time to patients and their loved ones. Just as we were three years ago, we remain united in this unprecedented and critical effort. Together, we will change the way we fight disease and help deliver #CuresNow. Click HERE to read the column online. ### Read More

Upton & DeGette: “It’s Finally Time for #CuresNow”

2016/11/30

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), sponsors of the 21st Century Cures Act, issued the following statement ahead of tomorrow’s House vote: “We need a game-changer to fight disease, and we have it with 21st Century Cures. It’s the most transformational bill to innovate our health care system since the National Cancer Act became law 45 years ago,” said Upton and DeGette. “This is truly a watershed moment for patients, their loved ones, medical professionals, researchers and scientists. The momentum has never been stronger in this three-year effort to deliver safe treatments and more hope, and we look forward to a strong supporting vote. We are thrilled to have a resounding endorsement from the White House. It’s finally time for #CuresNow.” 

 See the Statement of Administration Policy issued this evening by the White House HERE. Learn about the 21st Century Cures Act HERE. ### Read More

Sigal & McClellan: “Together, we have the capacity to heal”

2016/11/29

WASHINGTON, DC – As the 21st Century Cures Act draws closer to Wednesday’s monumental vote, two distinguished voices are encouraging advocates on the #Path2Cures to sprint for the finish. The latest call from the medical community for #CuresNow is made by Dr. Ellen V. Sigal, Chair and Founder of Friends of Cancer Research, and Dr. Mark McClellan, Director of the Margolis Center for Health Policy at Duke University and former FDA Commissioner, who argue that the landmark legislation presents “a rare unifying force.” The pair highlight the bill’s patient-centered measures aimed at helping the FDA and NIH better address the urgent needs of millions of Americans and loved ones affected by disease. “The bill translates recent progress in scientific understanding of disease mechanisms, data integration and analysis, and patient engagement to streamline and speed the development of medical treatments while enabling a deeper understanding about their safety and effectiveness for particular patients. It gives the FDA and NIH needed funding, staff, and hiring flexibility to take advantage of these opportunities. These new tools to promote health also help create jobs and boost American competitiveness globally,” write Sigal and McClellan. They continue, “It’s no wonder that the Cures bill has attracted rare bipartisan support. Ultimately, we cannot afford to have two of the nation’s premier public health and safety organizations operating with anything less than the best possible methods, resources, and people.” [[{"fid":"1849","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"110","width":"395","class":"media-element file-full"}}]] November 25, 2016 After a Contentious Election, A Rare Unifying Force: Pass Cures Now By Ellen V. Sigal, Ph.D., and Mark McClellan, M.D., Ph.D. After a deeply contentious election, Congress has an opportunity to embrace common ground. The House and Senate should pass the 21st Century Cures Act to bolster the life-saving work of the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The “Cures bill” unites us — a former FDA Commissioner and the founder of a non-profit that advances innovation in cancer research and treatment — because it brings the latest scientific opportunities to the urgency of saving lives. Defeating life-threatening diseases is a priority that should transcend political divides — after all, disease knows no party or ideology. For two years, bipartisan leaders in Congress, with the help of expert doctors and scientists, have crafted a package of the most critical programs and regulatory changes needed to improve the nation’s health and unlock the potential of the FDA and NIH. Congress is expected to vote on the bill after Thanksgiving, perhaps the bill’s last clear chance. The Cures bill deserves urgent support not only because it is about accelerating cures, but also because it reflects extensive and comprehensive work on a bipartisan basis over two years to identify effective ways to do it. The bill translates recent progress in scientific understanding of disease mechanisms, data integration and analysis, and patient engagement to streamline and speed the development of medical treatments while enabling a deeper understanding about their safety and effectiveness for particular patients. It gives the FDA and NIH needed funding, staff, and hiring flexibility to take advantage of these opportunities. These new tools to promote health also help create jobs and boost American competitiveness globally. The Cures bill draws inspiration not from Washington insiders, but from scientists and medical professionals who confront disease every day. Resting on the bedrock premise that patients come first, the Cures bill includes a set of reforms that will yield better science, support, and structures — providing more tools for the FDA to use without compromising its gold standard of efficacy and safety. For example, the bill enables the power of collaboration and big data to bring 21st century tools and richer sources of patient information to bear in the development and use of new treatments. It also helps the FDA incorporate patient perspectives as never before, making patient preferences and self-reported information integral to drug development. Finally, the bill would advance the development of precision medicine, reflecting a scientifically-driven shift toward more targeted and effective treatment. Ultimately, the Cures bill will help speed new, improved treatments to those patients with the most urgent needs. … Congress should pass the Cures bill to leverage the latest science to save lives, and to show the nation that, together, we have the capacity to heal when it matters most. Click HERE to read the full column online. ###    Read More

Breaking Down 21st Century Cures: Part 2

2016/11/29

The 21st Century Cures Act will accomplish what it says, delivering safe new cures and treatments to patients across the nation. Earlier today we looked at five themes of the landmark, nonpartisan legislation – delivering hope, removing barriers to research collaboration, incorporating patient feedback into the drug development process, promote personalized medicine, and modernizing clinical trials. As Energy and Commerce Committee Chairman Fred Upton (R-MI) has said, “We’re closing in on what’s truly a once-in-a-generation, transformational opportunity to change the way we treat disease.” Here’s part two of our breakdown on why patients and families across the country need #CuresNow. [[{"fid":"1843","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"630","width":"1200","style":"width: 450px; height: 236px;","class":"media-element file-full"}}]] 21st Century Cures clarifies the regulatory path so we can speed up the creation and deployment of innovative health tools like medical apps. [[{"fid":"1844","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"630","width":"1200","style":"width: 450px; height: 236px;","class":"media-element file-full"}}]] 21st Century Cures will create new economic incentives for the development of therapies for serious and life-threatening conditions, including rare diseases. New incentives will help create more, faster cures. [[{"fid":"1845","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"630","width":"1200","style":"width: 450px; height: 236px;","class":"media-element file-full"}}]] 21st Century Cures will create a new coordinating mechanism to ensure the efficiency of connections between scientific discovery, drug and device development, and how these therapies are approved and made available to patients. [[{"fid":"1846","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"630","width":"1200","style":"width: 450px; height: 236px;","class":"media-element file-full"}}]] 21st Century Cures creates the Innovation Fund, a dedicated funding stream for the NIH and the FDA that will allow Congressional appropriators to invest additional resources without impacting current budget caps. It will also invest more resources for the next generation of scientists, working to develop the cures and treatments of tomorrow. [[{"fid":"1847","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"630","width":"1200","style":"width: 450px; height: 236px;","class":"media-element file-full"}}]] 21st Century Cures will ensure the U.S. has the tools, skills, and individuals to remain the medical innovation capital of the world. For more information on 21st Century Cures, click HERE. To read part one of this two-part series, click HERE. Read More

RESCHEDULED: #SubOversight to Examine EPA’s Role in VW Settlement Implementation NEXT WEEK

2016/11/29

WASHINGTON, DC – The Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), has rescheduled its previously postponed hearing entitled Volkswagen’s Emissions Cheating Settlement: Questions Concerning ZEV Implementation for Tuesday, December 6, 2016, at 10 am in room 2322 of the Rayburn House Office Building. Members will examine the investment commitments attached to the recently approved Partial Consent Decree in the Volkswagen “Clean Diesel” settlement. The hearing will examine the $2 billion investment Volkswagen is required to make in Zero Emission Vehicle (ZEV) infrastructure, as well as the $2.7 billion to be paid into the NOx Mitigation Trust. On November 1, 2016, full committee Chairman Fred Upton (R-MI) and subcommittee Chairman Murphy sent EPA letters regarding EPA’s role in overseeing the National Zero Vehicle Investment Commitment and requesting additional information about the NOx Mitigation Trust. To read the letters sent to EPA and their responses, click here. The Majority Memorandum, witness list, and witness testimony will be available HERE as they are posted. ###  Read More

#RecordOfSuccess: Lance Bill to Protect Consumers Clears Final Legislative Hurdle

2016/11/29

WASHINGTON, DC – On Monday evening, the Senate unanimously passed H.R. 5111, the Consumer Review Fairness Act, authored by Commerce, Manufacturing, and Trade Subcommittee Vice Chairman Leonard Lance (R-NJ). The bipartisan bill would prohibit gag clauses that prevent consumers from publishing truthful reviews and would authorize the FTC, and states, to enforce the Act with civil penalties. H.R. 5111 passed the House by voice vote in September. “This law is about protecting consumers who post honest feedback online. Online reviews and ratings are critical in the 21st century and consumers should be able to post, comment and tweet their honest and accurate feedback without fear of retribution. Too many companies are burying non-disparagement clauses in fine print and going after consumers when they post negative feedback online. This will now end,” said Vice Chairman Leonard Lance. Full committee Chairman Fred Upton (R-MI) added, “The Energy and Commerce Committee has a proud record of protecting and empowering consumers, and this bipartisan solution will help restore fairness for online reviews. Websites like Yelp and Angie’s List have become invaluable resources for folks in the 21st century, offering insight on everything from finding a restaurant, hotel room, to a handyman. The bottom line is that consumers shouldn’t fear retribution from a company when they post an honest review. I look forward to this bill by Rep. Lance being swiftly signed into law and becoming an important part our record of success.” The legislation was a result of the Disrupter Series, which aims to match innovation-friendly reforms to 21st century realities. Over the past year, the series has provided an opportunity for the committee to highlight how federal policies help and hinder growth of emerging technologies. The committee’s work to modernize government for the innovation era continues. Also passing the Senate, was H.R. 4665, the Outdoor REC Act of 2016, authored by Rep. Don Beyer (D-VA) which directs the Department of Commerce to conduct an assessment and analysis of the outdoor recreation economy to ensure that it is measured and accounted for by the federal government as part of the country’s GDP. Both of these bills now head to the president to be signed into law. “The outdoor recreation industry has become a significant driver of job and economic growth here in Southwest Michigan and across the country. This common-sense, bipartisan bill will help optimize investments in this growing industry,” said Chairman Upton. “It’s critical that we continue to work together to strengthen our natural resources like the Great Lakes and also improve our outdoor recreation system. Learn more about the Energy and Commerce Committee’s legislative accomplishments and its #RecordOfSuccess online HERE. Read More

Breaking Down 21st Century Cures: Part 1

2016/11/29

The 21st Century Cures Act will accomplish what it says, delivering safe new cures and treatments to patients across the nation. Patients are waiting desperately for a cure or raising awareness for a rare disease, and hoping that the nonpartisan 21st Century Cures Act will become law and change the landscape for how diseases are treated. It's an innovation game-changer. As Energy and Commerce Committee Chairman Fred Upton (R-MI) has said, “We’re closing in on what’s truly a once-in-a-generation, transformational opportunity to change the way we treat disease.” But there are many important aspects to 21st Century Cures. Here’s part one (of two) of our breakdown on why patients and families across the country need #CuresNow. [[{"fid":"1836","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"245","width":"468","class":"media-element file-full"}}]] The 21st Century Cures Act will accelerate the discovery, development, and delivery of life-saving and life-improving therapies. [[{"fid":"1837","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"245","width":"468","class":"media-element file-full"}}]] While protecting privacy, 21st Century Cures will break down existing barriers to sharing and analyzing the growing amount of health data generated in research and clinical settings. [[{"fid":"1838","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"245","width":"468","class":"media-element file-full"}}]] 21st Century Cures will strengthen the FDA’s ability to take the direct experience of patients with particular diseases and conditions, and the effect of their current therapies, and use that data to modify and improve potential treatments. [[{"fid":"1839","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"245","width":"468","class":"media-element file-full"}}]] 21st Century Cures will provide guidance for the broader, more collaborative development, understanding, and utilization of drug development tools, which can be used for earlier assessment of how a particular therapy is working and on whom. The bill will ensure patients can be treated based on their unique characteristics at the appropriate time. [[{"fid":"1840","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"245","width":"468","class":"media-element file-full"}}]] 21st Century Cures will allow greater use of patient generated registries that speed the recruitment of participants, allowing faster and cheaper results. It will also allow researchers to screen patients in advance to determine if their genetic predisposition makes them better candidates for targeted therapies. For more information on 21st Century Cures, click HERE. Stay tuned for part two this afternoon. ### Read More

Upton Statement on Rep. Price’s Nomination for HHS Secretary

2016/11/29

WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) today issued the following statement after President-elect Donald Trump announced the nomination of Rep. Tom Price, M.D. (R-GA) for the position of Health and Human Services (HHS) Secretary. “The Department of Health and Human Services will have a lot on its plate next year, and I’m glad that we'll have a doctor who knows health care inside and out leading the way. It’s a brilliant choice. With Dr. Price at the helm, I know we will see meaningful reforms that the American people want and need. I congratulate Dr. Price on this new endeavor, and look forward to continuing working together to improve the state of health care in America." ### Read More

VIDEO: What You Need to Know About 21st Century Cures in 109 Seconds

2016/11/28

WASHINGTON, DC – Three years ago 21st Century Cures started as an idea. The goal: to bring our health care innovation infrastructure into the 21st century, delivering hope for patients and their loved ones, and providing the necessary resources to researchers who are looking to discover the next generation of cures and treatments. [[{"fid":"1835","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"258","width":"468","class":"media-element file-full"}}]] Watch the video HERE. Health care innovation is happening at lightning speed today. From the mapping of the human genome to the rise of personalized medicines that are linked to advances in molecular medicine, we have seen constant breakthroughs that are changing the face of disease treatment, management, and cures. Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era. We have dedicated scientists and bold leaders at agencies like the NIH and the FDA, but when our laws don’t keep pace with innovation, we all lose. By accelerating the critical cycle of discovering, developing, and delivering new cures and treatments, we can close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives. Want more information? Click HERE to read a quick breakdown, or click HERE to read the section by section. ### Read More

21st Century Cures: Fostering Innovation

2016/11/28

[[{"fid":"1834","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"208","width":"398","class":"media-element file-full"}}]] 21st Century Cures is an innovation game-changer. This legislation brings our health care infrastructure into the 21st century, delivering much needed hope for patients and their loved ones. It accelerates the cycle of discovering, developing, and delivering new cures and treatments and ensures that America remains the global leader in biomedical innovation. The bill provides a once-in-a-generation opportunity to help researchers change the way we fight disease. CATALYZES CUTTING-EDGE RESEARCH and personalized drug development.  Authorizes innovation prize competitions to advance biomedical science for diseases that are serious and represent a significant burden. (Section 2002) Establishes the Precision Medicine Initiative to help researchers develop medicines tailored to individuals, rather than one-size-fits-all treatments. (Section 2011) Provides opportunities for new researchers and promotes earlier research independence. (Section 2021) Supports high-risk, high-reward research that has the potential to transform the scientific field. (Section 2036)   Expedites the development and review of drugs for subgroups of rare disease patients by authorizing FDA to rely on data submitted in previously approved applications involving similar gene targeting technology. (Section 3012) Reauthorizes the pediatric priority review voucher program incentivizing the development of drugs for rare pediatric diseases. (Section 3013)  MODERNIZES CLINICAL TRIALS and evidence development. Directs FDA to provide clarity to drug developers about incorporating novel clinical trial designs into drug development. (Section 3021) Supports the utilization of real-world evidence in regulatory decision-making. (Section 3022) Harmonizes various regulations protecting patients in clinical trials to avoid duplication and unnecessary delays that researchers face on a daily basis. (Section 3023) Authorizes FDA to rely upon qualified data summaries to support the approval of supplemental applications. (Section 3031) Establishes an alternative approval pathway for sorely needed antimicrobial drugs intended for limited patient populations. (Section 3042) BRINGS FDA into the 21st century. Removes the silos at FDA by transitioning the agency towards a disease-centric approach. (Section 3073) Codifies a structured framework at FDA for the submission, review, and qualification of biomarkers that can be used to evaluate the safety and effectiveness of a product earlier in the process. (Section 3011) Fosters development and utilization of incredibly promising approaches to regenerative medicine. (Sections 3033 - 3036) Reforms the flawed combination product review process to provide certainty to manufacturers developing these complex therapies and technologies. (Section 3038) Provides long-overdue clarification regarding how medical product manufacturers can discuss the value of therapies and technologies with insurers and formulary committees. (Section 3037) IMPROVES MEDICAL DEVICE REVIEW PROCESS and reduces unnecessary regulation. Empowers FDA to apply efficient and flexible approaches to expedite the development and review of new medical technologies like the breakthrough path for drugs that Congress made law four years ago. (Section 3051) Streamlines medical device and diagnostic regulations and ensures FDA uses the least burdensome approaches necessary. (Sections 3052-3059) Exempts certain software and personal health apps from FDA regulation. (Section 3060) EMPOWERS PATIENTS to participate in research and development activities. Ensures that patients can voluntarily provide hospitals and research institutions authorization to use their personal health data for future research purposes. (Section 2063) Puts patients at the center of the drug development and FDA review process, requiring the FDA to routinely incorporate patient input and experiences into their regulatory decision-making. (Sections 3001-3004) INCENTIVIZES THE DEVELOPMENT of medical countermeasures and vaccines. Establishes a priority review voucher program that encourages the development of drugs and vaccines to protect Americans against agents that present a national security threat, like a bioterror attack. (Section 3086) Provides current and potential vaccine manufacturers with more predictable CDC timeframes. (Section 3091-3093) FOSTERS INTEROPERABLE Health Records. Expedites the interoperability of electronic health record systems to help make good on the $30 billion taxpayer investment and benefit patients, providers, and researchers. (Sections 4003-4006)  Read More

21st Century Cures: It Started as an Idea

2016/11/27

WASHINGTON, DC – The #Path2Cures has been a three-year journey, that all started with a simple idea. The goal: to bring our health care innovation infrastructure into the 21st century, delivering hope for patients and their loved ones, and providing the necessary resources to researchers who are looking to discover the next generation of cures and treatments. [[{"fid":"1833","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"294","width":"516","class":"media-element file-full"}}]] Click HERE to watch the April 2014 video. By accelerating the critical cycle of discovering, developing, and delivering new cures and treatments, we can close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives. With support from every corner of the country, and from the top researchers, academics, medical and patient advocacy groups, the push to deliver #CuresNow has only intensified. In advance of next week’s floor vote, we encourage you to take a look back at how the 21st Century Cures Act all began. And if you missed this weekend’s news, here’s a new #CuresIn4Words – Back in the House. Need a refresher on Cures? Get up to speed with this quick breakdown, or read the section by section here. ###  Read More

Landmark Mental Health Reforms to Advance NEXT WEEK

2016/11/26

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) today issued a statement on progress to advance landmark mental health reforms. “The inclusion of long-sought reforms to our mental health system is the result of thoughtful, bipartisan legislating," said Upton and Murphy. "We thoroughly examined the realities of our current mental health care system and how it could and should be improved. This news is a win for families in mental health crisis all across the country. Families have reason to be hopeful. Help will soon be on the way. This effort, first launched in the wake of the Newtown tragedy, helped change the conversation on mental health in America. And these reforms are much too important to not get done this Congress.” The mental health reforms being combined with the 21st Century Cures Act for a medical innovation package, the product of recent bipartisan and bicameral negotiations, and are based off of Chairman Murphy’s H.R. 2646, the Helping Families in Mental Health Crisis Act. For more information on the 21st Century Cures Act, and the overall agreement, click HERE. For a section by section of the bill, click here. ###  Read More

21st Century Cures Bill Released

2016/11/26

WASHINGTON, DC – House and Senate health committee leaders have released the final "21st Century Cures” bill and announced that the House of Representatives will vote Wednesday on a $6.3 Billion landmark medical innovation package that will accelerate the discovery, development, and delivery of new cures and treatments and provide new funding for the National Institutes of Health and Food and Drug Administration. The leaders said the House would also vote Wednesday to include in the Cures bill legislation that updates major mental health programs for the first time in a decade. The new funding includes $1 billion in state grants to fight opioid abuse. "It is time to vote on 21st Century Cures, mental health legislation, and help fund the fight against opioid abuse. The House vote on Wednesday will be an extraordinary opportunity to help almost every American family. It will advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices. It will address the needs of the one in five adult Americans who suffer mental illness," said House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN). “What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017.” Upton and Alexander continued, “We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate. America’s patients are waiting on us and we will deliver #CuresNow.” Senate Majority leader McConnell has described the Cures bill as "the most important legislation Congress will consider this year” and said that, after the House acts, the Senate will act before the end of December.    The bill was first introduced by Chairman Upton and Rep. Diana DeGette (D-CO). The 21st Century Cures agreement will: Help bring drugs and devices to market more quickly and at less cost by making needed reforms to the FDA, including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software like fitbit or calorie counting apps. Provide $4.8 billion to National Institutes of Health, including: $1.4 billion for President Obama’s Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; $1.8 billion for Vice President Biden’s "Cancer Moonshot” to speed research; and $1.6 billion for the BRAIN initiative to improve our understanding of diseases like Alzheimer's and speed diagnosis and treatment. Provide $500 million to the Food and Drug Administration. Provide $1 billion in grants to states to address the opioid crisis. Address the country’s mental health crisis and help the one out of five adult  Americans suffering from mental illness and substance abuse disorders receive the care they need. For more information about the 21st Century Cures Act, click here. For a section by section of the bill, click here. ###  Read More

Committee Leaders Comment on 2017 Final RFS Standard

2016/11/23

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI), Energy and Power Subcommittee Vice Chairman Pete Olson (R-TX), and Environment and the Economy Subcommittee Chairman John Shimkus (R-IL), today issued the following statement in response to EPA’s final rule setting out the 2017 requirements for the Renewable Fuel Standard (RFS).  “We need to strike the right balance for everyone affected by the RFS – farmers, biofuel producers, refiners, carmakers, and most importantly consumers. We will continue to monitor the program and its impacts,” said Upton, Olson, and Shimkus. “We also appreciate that, unlike previous years, EPA finalized its 2017 rule by the deadline, which greatly facilitates compliance.” The RFS specifies increasing amounts of renewable fuels to be added to the nation’s gasoline and diesel fuel supply each year through 2022, but it provides EPA with some authority to lower the annual volumes as circumstances warrant. The volumes for 2017 are slightly higher than proposed by EPA, reflecting the agency’s belief that more of these fuels can be utilized without any problems. For corn ethanol, the final target is 15 billion gallons, which is the amount originally set by Congress in 2007. ###  Read More

Next Week’s #SubOversight Hearing Postponed

2016/11/23

WASHINGTON, DC – The Energy and Commerce Committee’s Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), today announced that the Thursday, December 1, 2016 hearing entitled, “Volkswagen’s Emissions Cheating Settlement: Questions Concerning ZEV Program Implementation,” has been postponed.  Information about rescheduling the hearing will be posted here as it’s available. ###  Read More

Look Ahead: Committee Announces Hearing Schedule for the Week of November 28

2016/11/23

[[{"fid":"1832","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"220","width":"339","class":"media-element file-full"}}]] WASHINGTON, DC – The House Committee on Energy and Commerce today announced its hearing schedule for the week of November 28. On Wednesday, the Subcommittee on Health will hold a hearing to examine a new discussion draft with updated bill text for H.R. 1151, the USPSTF Transparency and Accountability Act of 2015, available here. H.R. 1151 was introduced last year by full committee Vice Chairman Marsha Blackburn (R-TN) and Rep. Bobby Rush (D-IL) to improve the oversight and transparency of the United States Preventive Services Task Force (USPSTF). The revised bill will require specialists and sub-specialists to be involved in reviewing the preventive services that the task force examines. The updated discussion draft would also require the Government Accountability Office to submit a report comparing USPSTF’s recommendations with other federal government health guidelines. Additionally, the new discussion draft allows the Secretary of Health and Human Services to remove certain preventive services under the Medicare program, if such changes are needed. The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. Hearing and Meeting Details Wednesday, November 30, 2016 10:30 AM 2322 Rayburn HOB Subcommittee on Health Hearing on “Examining the United States Preventive Services Task Force” Thursday, December 1, 2016 The Subcommittee on Oversight and Investigations hearing on Volkswagen's Emissions Cheating Settlement has been POSTPONED. Read More

Upton & Thune Request Pause on Controversial Regulations

2016/11/22

WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate Committee on Commerce, Science, and Transportation Chairman John Thune (R-SD) today sent letters to both Federal Trade Commission (FTC) Chairman Edith Ramirez and Consumer Product Safety Commission (CPSC) Chairman Elliot Kaye requesting a pause on any controversial new regulations. “The American people decided to make a change on November 8th – seeking a return to pro-growth, business-and-consumer-friendly regulations that put jobs first,” commented Upton and Thune. “We urge the leaders of the FTC and CPSC to pay close attention to the wishes of the American people and refrain from pushing new regulations that could create uncertainty for consumers and business.” Upton and Thune write: We are writing to express our thoughts about the pending [Federal Trade Commission (FTC)] agenda in light of the recent election and upcoming transition. While the leadership of the [FTC] will soon change, congressional oversight of the Commission will continue.  Therefore, any action taken by [FTC] before a new chairman is designated will receive particular scrutiny.  While we expect and encourage the [FTC] to continue its routine merger reviews and consumer protection enforcement in support of competition and on behalf of American consumers, we strongly encourage the [FTC] to avoid directing its attention and resources in the coming months on complex, partisan, or otherwise controversial items that the new Congress and new Administration will have an interest in reviewing. To read the letter to the FTC, click here. To read the letter to the CPSC, click here. Read More

HEARING: #SubOversight to Examine EPA’s Role in VW Settlement Implementation NEXT WEEK

2016/11/22

WASHINGTON, DC – The Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), has scheduled a hearing for Thursday, December 1, 2016, at 10 a.m. in 2322 of the Rayburn House Office Building. The hearing is entitled, “Volkswagen’s Emissions Cheating Settlement: Questions Concerning ZEV Program Implementation.” The hearing will focus on the investment commitments attached to the recently approved Partial Consent Decree in the Volkswagen “Clean Diesel” settlement. Members will examine the $2 billion investment Volkswagen is required to make in Zero Emission Vehicle (ZEV) infrastructure, as well as the $2.7 billion to be paid into the NOx Mitigation Trust. On November 1, 2016, full committee Chairman Fred Upton (R-MI) and subcommittee Chairman Murphy sent letters to the Environmental Protection Agency (EPA) regarding EPA’s role in overseeing the National Zero Vehicle (ZEV) Investment Commitment and requesting additional information about the NOx Mitigation Trust. “For over a year now the committee has been examining the VW cheating scandal and remains committed to holding VW accountable for its actions, as they represent a fundamental violation of public trust,” said Chairman Murphy. “Recently, VW reached a $15 billion settlement with the federal government and other parties in which $4.7 billion of the funding will be directed to zero emissions vehicle infrastructure investments and to the emissions mitigation trust. These provisions aim to remedy the market and environmental impacts of VW’s deceitful actions; however, questions remain in regards to the implementation of these provisions. During this hearing, the committee will seek answers regarding the EPA’s role in managing and overseeing the ZEV Investment Commitment, the potential for VW to gain an unfair competitive edge in the EV market, and the impacts of these provisions on transportation and environmental policy goals.” To read both the letters sent to EPA and their responses, click HERE. The Majority Memorandum, witness list, and witness testimony will be available HERE as they are posted. ###  Read More

Letters to FTC Chairwoman Ramirez and CPSC Chairman Kaye Regarding Regulatory Freeze

2016/11/22

Excerpt: We are writing to express our thoughts about the pending [Federal Trade Commission (FTC)] agenda in light of the recent election and upcoming transition. While the leadership of the [FTC] will soon change, congressional oversight of the Commission will continue.  Therefore, any action taken by [FTC] before a new chairman is designated will receive particular scrutiny.  While we expect and encourage the [FTC] to continue its routine merger reviews and consumer protection enforcement in support of competition and on behalf of American consumers, we strongly encourage the [FTC] to avoid directing its attention and resources in the coming months on complex, partisan, or otherwise controversial items that the new Congress and new Administration will have an interest in reviewing. To read the letter to the FTC, click here. To read the letter to CPSC, click here.   Read More

Frist & von Eschenbach: Pass #CuresNow

2016/11/22

WASHINGTON, DC – Two medical doctors who are best known for their time in Washington are reiterating their calls for passing the 21st Century Cures Act. Former Senate Majority Leader Bill Frist (R-TN) and former FDA Commissioner Andy von Eschenbach have joined forces in The Hill, highlighting the medical innovation bill and explaining why Congress can’t wait until next year to advance legislation. “As medical doctors we have witnessed the potential of life-changing treatments, and as a former Senate Majority Leader and former Food and Drug Administration (FDA) Commissioner who have spent years in public service — we recognize this rare and exciting opportunity for Congress to pass legislation that will affect the health and well-being of millions of Americans suffering from diseases today with no cure,” write Frist and von Eschenbach. The medical leaders continue, “The Cures legislation is the product of two years of negotiation, resulting in nearly unanimous support among members of the House of Representatives and the Senate Health, Education, Labor, and Pensions (HELP) Committee at a time when many believed Washington was incapable of compromise. … If 21st Century Cures is not passed before the end of this term, the new Congress of 2017 will need to start all over again. This is a tragedy on many fronts; progress in biomedical research and creation of innovative therapies will be delayed, precious time and energy will be diverted from other pressing legislation, and the new administration will be deprived of having a foundation designed with today’s medical advances in mind.” [[{"fid":"1829","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"165","width":"163","class":"media-element file-full"}}]] November 22, 2016 The time to act is now: Bipartisan action will accelerate cures for Americans By William H. Frist, MD and Andrew von Eschenbach, MD With the election over, speculation is rampant on what this means for politics and policy in 2017.  We need to take a step back however, and realize there is critical work to be completed by Congress in 2016, to set the stage for a new generation of medical innovation, and demonstrate to the American people that Washington is not broken. Congress has four remaining work weeks in Washington to hash out the budget and hopefully finish work on the “21st Century Cures” legislation which will accelerate the discovery, development, and delivery of safe and effective medical therapies.  As medical doctors we have witnessed the potential of life-changing treatments, and as a former Senate Majority Leader and former Food and Drug Administration (FDA) Commissioner who have spent years in public service — we recognize this rare and exciting opportunity for Congress to pass legislation that will affect the health and well-being of millions of Americans suffering from diseases today with no cure. The Cures legislation is the product of two years of negotiation, resulting in nearly unanimous support among members of the House of Representatives and the Senate Health, Education, Labor, and Pensions (HELP) Committee at a time when many believed Washington was incapable of compromise.  Indeed, in late September, Senate and House leadership, and bipartisan leaders in the Senate HELP Committee and House Energy and Commerce Committee committed to getting a bill passed this fall. Some small roadblocks remain, namely agreement on funding sources and levels.  This is worth working through.  If 21st Century Cures is not passed before the end of this term, the new Congress of 2017 will need to start all over again. This is a tragedy on many fronts; progress in biomedical research and creation of innovative therapies will be delayed, precious time and energy will be diverted from other pressing legislation, and the new administration will be deprived of having a foundation designed with today’s medical advances in mind.  Key elements of the medical innovation legislation advanced by the House of Representatives and Senate HELP Committee ripe for action include: Enhancing FDA’s ability to hire and retain staff with scientific expertise, so that our best and brightest have added incentive to engage in public service; Advancing the President’s Precision Medicine Initiative to shift from one-size-fits-all medical care to individualized treatments, tailored to a patient’s genetic makeup, environment and lifestyle; Supporting the Vice President’s Cancer Moonshot, to make more therapies available to more patients, while improving ability to prevent and detect disease early; Involving patients as partners in the development of drugs and devices to ensure their experiences are reflected in assessments of treatment benefits and risks; Improving regulatory processes associated with new emerging therapies such as regenerative medicine and hybrid products that are not pure devices, drugs or biologics, such as drug-emitting skin patches for treatment of early Parkinson’s disease; Increasing use of real-world evidence – data that reflects the actual experience of patients outside of clinical trials – to inform the development, approval, and surveillance of medical products; Clarifying regulatory authority around health information technology to increase private sector investment in innovation in the U.S.; and Increasing electronic information sharing and interoperability to improve health, advance research, and support higher quality, more cost-effective, patient-centered care. Simply put, this legislation will reduce the cost and time to bring drugs or devices to market while maintaining product safety, increase funding for vital research that accelerates the discovery of new therapies for today’s incurable diseases, and give our federal agencies not only new resources, but also new policies and practices to optimize their role in advancing health care treatments for Americans. The health and wellness of our country is not a partisan issue.  After nearly two years of divisive language from a lengthy presidential campaign, we have an opportunity to demonstrate that Washington can still come together for the betterment of our country.  The Cures medical innovation package is a bipartisan solution to some of our greatest medical challenges today, and can be a message of hope for those skeptical that the federal government is still capable of governing.  We strongly urge Congress to pass comprehensive medical innovation legislation in 2016. Click HERE to read the column online. ### Read More

21st Century Cures 101

2016/11/22

[[{"fid":"1828","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"286","width":"546","class":"media-element file-full"}}]] WASHINGTON, DC – The 21st Century Cures Act, an unprecedented nonpartisan bill to deliver new cures and treatments to patients, continues to remain a top legislative priority. As lawmakers prepare for the lame duck session, here’s a quick refresher on the #Path2Cures. As House Energy and Commerce Committee Chairman Fred Upton (R-MI) has repeatedly described, 21st Century Cures as “a once-in-a-generation, transformational opportunity to change the way we treat disease.” IT STARTED AS AN IDEA Chairman Upton came up with the idea of 21st Century Cures in late 2013 believing that it was time for Congress to do something positive to boost research and innovation, and accelerate the discovery, development, and delivery of new cures and treatments. Upton teamed up with Rep. Diana DeGette (D-CO) and formally launched the effort via video in April 2014. Watch HERE. Meet the two little Michigan girls who helped inspire Cures HERE. OPEN, TRANSPARENT, COLLABORATIVE PROCESS The Energy and Commerce Committee released a half-dozen white papers and two discussion drafts, soliciting feedback every step of the way. The committee and its members held a number of hearings and dozens of roundtables in Washington and across the country. Since day one, the committee has been working with patients, patient advocates, researchers, academics, health professionals, and innovators, as well as the FDA, NIH, and White House.  INNOVATION GAME-CHANGER Cures brings our health care infrastructure into the 21st century by catalyzing cutting-edge research and personalized medicine, modernizing clinical trials, updating FDA for the innovation era, and empowering patients to participate in research activities. 21st Century Cures has has helped change the conversation on boosting medical research, which is now universally promoted by policymakers. GOOD FOR PATIENTS The 21st Century Cures Act will help deliver more cures and treatments to patients more quickly by embracing incredible advances in science and technology. There are 10,000 known diseases, 7,000 which are rare, there are treatments for only 500. The mapping of the human genome and rise of personalized medicine has the potential to unleash a new generation of health care. 21st Century Cures will allow scientists and regulators to fully embrace these advances and bridge the gap between the number of diseases and the number of treatments. GOOD FOR JOBS & THE ECONOMY 21st Century Cures is not only a patients bill; it is a jobs bill. The United States has long been the leader in medical innovation, but in 2010, more biotechnology companies were formed in China than the United States. The investment in, and dedication to, science and research sends a signal that the United States remains the health care innovation capital of the world, helping to keep and create good jobs here at home. The 21st Century Cures Act will also save money by developing cures rather than continuing to shoulder the heavy cost of chronic illness, so much of which is borne by taxpayers. PASSED THE HOUSE 344-77 On July 10, 2015, the House of Representatives approved H.R. 6 by a bipartisan vote of 344-77. The Senate HELP Committee has passed 19 bills as part of it’s Innovation package. House and Senate leaders have worked closely with the administration and White House as the effort seeks to advance the president’s Precision Medicine Initiative and the vice president’s Cancer Moonshot. OVER 700 GROUPS SUPPORT #CURESNOW 21st Century Cures has achieved strong support from the nation’s leading patient advocates, cancer groups, research universities, & research leaders. BONUS VIDEO Watch this video detailing our journey on the #Path2Cures HERE.   ### Read More

From Diagnosis to “On Top of the World” - Imagine Dragons Frontman on the #Path2Cures

2016/11/19

WASHINGTON, DC – Dan Reynolds of Imagine Dragons might be feeling “On Top Of The World,” but it hasn’t always been that way. Eight years ago, at the age of 21, Reynolds began experiencing back pain so terrible, he had to cancel performances. Reynolds tells People Magazine, “It was beyond the pain that you feel when it’s just a back ache. It felt like someone was drilling my nerves. It was right when the band was starting to have minor success — we were starting to sell out small clubs, and we were playing these very active shows and it started to make me have to cancel shows.” “I couldn’t get on stage. I couldn’t move, I couldn’t sleep at night, I couldn’t perform without standing perfectly still. I couldn’t sit down for more than a half an hour,” added Reynolds. Like many other patients, it took awhile for Reynolds’ doctors to diagnose what was happening. The diagnose came after Reynolds asked his doctors if he had ankylosing spondylitis (AS), a disease that two of his siblings already knew they had. [[{"fid":"1824","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"261","width":"468","class":"media-element file-full"}}]] Click HERE to watch Reynolds talk about an online show to help raise awareness for patients with AS. Talking with People, Reynolds admits he was unsure about telling his fans about his battle with AS, saying, “I was shy to reveal it because it made me feel like something was wrong with me, or — to say the word disease, it’s such a drastic sounding word. And I didn’t want to admit to myself, or to anybody, that I was struggling with a disease.” The Imagine Dragons frontman says now it was silly to be so worried about it, and is now working to help raise awareness for AS, as well as help others struggling with the disease, via This AS Life Live!, which is in partnership with the Spondylitis Association of America (SAA) and Novartis. Reynolds comments, “I have a chance to really raise awareness and help people that are just becoming diagnosed to see that there’s actually light at the end of the tunnel… For me, I really wish that there was a place that I could have gone to where I was seeing a direct community. People talking and saying, ‘These are the things I’m feeling. These are the ways that I’m combatting it, and it’s working for me.’” For patients like Dan Reynolds, “It’s Time.” We need #CuresNow. [[{"fid":"1825","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"83","width":"216","class":"media-element file-full"}}]] November 15, 2016 Imagine Dragons Frontman Dan Reynolds Opens Up About ‘Debilitating’ Chronic Disease: ‘I Couldn’t Perform’ Eight years ago, Dan Reynolds was on the cusp of stardom — but his health was in turmoil. Reynolds, the frontman of Grammy-award winning band Imagine Dragons, tells PEOPLE that at age 21 he began to experience “debilitating” pain that forced him to cancel shows. “It was beyond the pain that you feel when it’s just a back ache. It felt like someone was drilling my nerves,” he says. “It was right when the band was starting to have minor success — we were starting to sell out small clubs, and we were playing these very active shows and it started to make me have to cancel shows.” He adds, “I couldn’t get on stage. I couldn’t move, I couldn’t sleep at night, I couldn’t perform without standing perfectly still. I couldn’t sit down for more than a half an hour.” Yet, countless visits to doctors couldn’t diagnose the pain source. Some suggested that Reynolds had sciatica, but the appropriate treatment didn’t combat it. The experience, Reynolds says, was “frustrating.” Then, at the suggestion of his brother, the vocalist consulted a rheumatologist to see if he had ankylosing spondylitis, a condition that two of his siblings suffer from. Ankylosing spondylitis, often referenced as AS, is a chronic inflammatory condition of the joints that can lead to extreme pain and in the worst cases, spinal fusion. “I went, and then they did the test to see if it’s in your genes — which it was, because it’s an autoimmune disease,” he says. “And then they diagnosed me and put me on a treatment plan, which fixed me almost immediately. Which was another sign that that’s what it was.” Reynolds’ treatment involves staying active and eating healthy — he does a lot of yoga, he says. What works is different for everyone though, he specifies, but swears by his rheumatologist. Now 29, Reynolds admits that he felt hesitation about sharing his diagnosis with Imagine Dragons’ fans. “I was shy to reveal it because it made me feel like something was wrong with me, or — to say the word disease, it’s such a drastic sounding word,” he says. “And I didn’t want to admit to myself, or to anybody, that I was struggling with a disease.” Now, after opening up, the singer says he’s not sure what he was afraid of — and that he’s ready to help others feel the same way through This AS Life Live!, an online, interactive talk show for patients with AS, hosted by patients with AS. “I have a chance to really raise awareness and help people that are just becoming diagnosed to see that there’s actually light at the end of the tunnel,” he tells PEOPLE of This AS Life Live!, which is in partnership with the Spondylitis Association of America (SAA) and Novartis. “For me, I really wish that there was a place that I could have gone to where I was seeing a direct community. People talking and saying, ‘These are the things I’m feeling. These are the ways that I’m combatting it, and it’s working for me. ‘” … Click HERE to read the full story online. ### Read More

E&C and Natural Resources Committee Leaders Comment on Energy Conference

2016/11/18

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Natural Resources Committee Chairman Rob Bishop (R-UT), today issued the following statement after the House sent the Senate its bipartisan proposal to the House-Senate energy bill. “This offer reflects policies that represent the current bipartisan consensus in the House,” said Upton and Bishop. “We welcome any suggestions from the Senate and remain open to continuing to work with our Senate colleagues and concluding this conference in a productive manner.” ### Read More

Upton Comments on FDA Decision on Lab Developed Tests

2016/11/18

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) today responded to the FDA’s decision not to finalize guidance on laboratory developed tests (LDTs). LDTs have been an important area of concern for the committee. The committee has held multiple hearings on LDTs (September 2014, November 2015), and has done extensive work to find a bipartisan path forward. Chairman Upton commented, “We appreciate FDA’s decision to refrain from finalizing its guidance on LDTs. It was the right call. Our committee has consistently believed that applying medical device regulations to LDTs via non-binding guidance documents is not the best approach. Diagnostics, regardless of whether they are developed in a lab or by a manufacturer, are critical to advancing precision medicine and raise complex policy issues the committee has been grappling with on a bipartisan basis. Working together, we are forging significant consensus among a number of patient groups, labs, and manufacturers around a 21st century approach uniquely designed with all diagnostic tests in mind from the outset. We look forward to discussing our efforts to date with additional stakeholders and completing our work next year.” ### Read More

Momentum Building for #CuresNow

2016/11/18

Momentum is building in the effort to deliver #CuresNow. Hundreds of the nation’s leading medical, academic, research, and patient advocacy groups have called on Congress to pass the 21st Century Cures Act before the end of the 114th Congress. As Chairman Fred Upton (R-MI) calls it, the landmark innovative effort is a “once-in-a-generation, transformational opportunity to change the way we treat disease.” Support that has rolled in the last several weeks includes: “Millions of Americans are desperately waiting for effective treatments and cures for their chronic disease or disability. The organizations that represent these people with chronic conditions urge Congress to pass the 21st Century Cures Act in 2016 in order to speed the development of treatments and cures. Patients simply can’t afford to wait – time is running out.” – National Health Council letter, signed by more than 200 patient-focused organizations “The House and Senate’s bipartisan efforts on such legislation in the 114th Congress have been truly extraordinary and should not go unfulfilled. … [W]e strongly encourage you to seize this notable opportunity and move an NIH Cures/innovation bill over the finish line.” – Association of Public & Land-Grant Universities and the Association of American Universities, representing more than 200 research universities “The importance of Congress funding the Cancer Moonshot Initiative as soon as possible by enactment of the 21st Century Cures Act in 2016 is without question. Waiting until next year to act is not an option for cancer patients and their families.” – One Voice Against Cancer letter, signed by 50 leading cancer organizations “Through hard work and compromise over the course of several years, the House Energy and Commerce Committee and Senate HELP Committee have been able to forge broad-based bipartisan agreement on legislation focused squarely on conquering diseases that rob Americans and patients throughout the world of health, independence and time. By applying supplemental funding for NIH and FDA and pursuing efficiencies in the R&D pipeline, the Cures initiative will empower our nation to find safe and effective solutions to health threats more quickly, and deliver those solutions to patients more efficiently.” – Research!America, a 360-member organization spanning patients, universities, academic health centers, industry, independent research institutes, scientific societies, and philanthropies “We believe Congress understands this opportunity, and is eager to act. The bipartisan leadership over the last two years in both the House and the Senate has been truly remarkable, and this legislation would be a crowning achievement for the 114th Congress. Putting this bill off until the next Congress likely means putting it off for the foreseeable future – a terrible outcome for our country.” – United for Medical Research, a coalition of 25 of the nation’s leading scientific research institutions and patient advocates “The 21st Century Cures Act and the Senate’s medical innovation bills are important steps towards fostering the delivery of innovative, safe, and effective treatments and cures for CVD [Cardiovascular disease] patients. An infusion of federal investment in the National Institutes of Health (NIH) is needed to rebuild our nation’s biomedical research capacity, which has seen its ability to fund promising research falter due to inflation over the past decade. We urge this legislative initiative’s timely passage before the adjournment of the 114th Congress, so that we may improve the pace of progress.” – Mended Hearts, Inc., the largest peer-to-peer support group for cardiovascular patients with more than 300 chapters and 20,000 members   ###   Read More

“Patients simply can’t afford to wait – time is running out.”

2016/11/17

WASHINGTON, DC – Patients can’t wait. That’s the message from over 200 of the nation’s leading patient advocacy organizations. A letter spearheaded by the National Health Council is urging bipartisan Congressional leaders, as well as The White House, to move forward and pass the 21st Century Cures Act. The letter, signed by more than 200 patient and research associations, states,” This is a patient-focused bill that will advance the discovery and development of treatments, strengthen the patient voice in the research and regulatory environment, increase funding for the National Institutes of Health and Food and Drug Administration, and greatly improve our innovation ecosystem.” The letter continues, “Millions of Americans are desperately waiting for effective treatments and cures for their chronic disease or disability. The organizations that represent these people with chronic conditions urge Congress to pass the 21st Century Cures Act in 2016 in order to speed the development of treatments and cures. Patients simply can’t afford to wait – time is running out.” Support continues to build for 21st Century Cures. Today’s letter comes on the heels of strong support from from the Association of Public & Land-Grant Universities (APLU) and the Association of American Universities (AAU), One Voice Against Cancer, and Research!America and United for Medical Research. The National Health Council letter was signed by: A Kids’ Brain Tumor Cure (PLGA Foundation) Abby Grace Foundation Abigail Alliance for Better Access to Developmental Drugs Adrenal Insufficiency United Adult Polyglucosan Body Disease Research Foundation Aidan Jack Seeger Foundation AliveAndKickn Allergy and Asthma NetworkAlliance for Aging Research Alliance for Cryoglobulinemia Alport Syndrome Foundation Alström Syndrome International Alzheimer's Association American Association for Respiratory Care American Autoimmune Related Diseases Association American Behcet's Disease Association American Cancer Society Cancer Action Network American Foundation for Suicide Prevention American Heart Association American Kidney Fund Amyloidosis Research Consortium Angioma Alliance Arthritis Foundation Association for Creatine Deficiencies Association for Research in Vision and Ophthalmology Asthma and Allergy Foundation of America Ataxia Telangiectasia Children's Project Autism Speaks Autoinflammatory Alliance Barth Syndrome Foundation Bcureful Bear Necessities Pediatric Cancer Foundation Bert's Big Adventure Beyond Celiac Bridge the Gap- SYNGAP Education and Research Foundation Cardio-Facio-Cutaneous International Caregiver Action Network Caregiver Voices United Center for Independence of the Disabled, NY Central Florida Behavioral Health Network Central Pain Syndrome Foundation Charles E. Holman Morgellons Disease Foundation Chase After a Cure Chasing Life Project CheckOrphan Children's Cardiomyopathy Foundation Children's Craniofacial Association Children's PKU Network CLOVES Syndrome Community Coalition Duchenne Coalition for Clinical Trials Awareness Colon Cancer Alliance Congenital Adrenal Hyperplasia Research, Education and Support Foundation (CARES Foundation) Congenital Hyperinsulinism International Consortium of Multiple Sclerosis Centers Conquer Myasthenia Gravis COPD Foundation Crestwood School District Cure CMD Cure HHT Cure JM Foundation Cure Sanfilippo Foundation CureCADASIL CureDuchenne Cutaneous Lymphoma Foundation DADA2 Foundation Debra of America Dementia Alliance International Dravet Syndrome Foundation Drew's Hope Scientific Research Foundation Dysautonomia International Dyskeratosis Congenita Outreach, Inc. Epilepsy Foundation Erik Metzler Foundation, Inc. EURORDIS- Rare Diseases Europe EveryLife Foundation for Rare Diseases Fabry Support & Information Group Fanconi Anemia Research Fund FasterCures Fibromuscular Dysplasia Society of America Fibrous Dysplasia Foundation Fight Colorectal Cancer Florida Society of Clinical Oncology (FLASCO) FMD Chat FORCE: Facing Our Risk of Cancer Empowered Foundation for Prader-Willi Research Friends of Cancer Research Garrett The Grand Gene Giraffe Project Genetic Alliance Global Colon Cancer Association Global Genes Global Healthy Living Foundation G-PACT Guardian Hands Foundation H.E.A.L.S of the South (Hepatitis Education, Awareness and Liver Support) Hannah's Hope Fund for GAN Hereditary Neuropathy Foundation Inc. Hermansky-Pudlak Syndrome Network Inc. Hope4Bridget HSAN1E Society Hunter Syndrome Foundation Huntington's Disease Society of America Hydrocephalus Association International Cancer Advocacy Network (ICAN) International Essential Tremor Foundation International FOP Association International Foundation for Autoimmune Arthritis International Organization of Multiple Sclerosis Nurses International Pemphigus & Pemphigoid Foundation International WAGR Syndrome Association International Waldenstrom's Macroglobulinemia Foundation (IWMF) JDRF Jonah's Just Begun-Foundation to Cure Sanfilippo Kalel's MPS Superhero Foundation Klippel-Feil Syndrome Freedom K-T Support Group Leiomyosarcoma Direct Research Foundation (LMSdr) Little Miss Hannah Foundation LMSarcoma Direct Research Foundation LuMind Research Down Syndrome Foundation Lung Transplant Foundation LUNGevity Lupus Alliance of Long Island/Queens Lupus Alliance of Upstate New York Lupus and Allied Diseases Association Lupus Foundation of America Lupus Foundation of Florida Lupus Foundation New England Lupus Foundation of Northern California Lupus Foundation of Pennsylvania Lupus Friends and Family Foundation Lupus LA Lupus Research Alliance Lymphangiomatosis & Gorham's Disease Alliance M-CM Network Mended Hearts Miracle for Madison & Friends MLD Foundation Moebius Syndrome Foundation Narcolepsy Network National Alliance on Mental Illness National Alopecia Areata Foundation National Eczema Association National Fragile X Foundation National Health Council National Kidney Foundation National Lymphedema Network National MPS Society National Multiple Sclerosis Society National Organization for Rare Disorders (NORD) National Patient Advocate Foundation National Psoriasis Foundation National Tay-Sachs & Allied Diseases Association, Inc. (NTSAD) Neurofibromatosis Network New England Regional Genetics Group, Inc. (NERGG) Noah’s Hope North Carolina Rare Disease Coalition Norton & Elaine Sarnoff Center for Jewish Genetics NUBPL Foundation Organic Acidemia Association Osteogenesis Imperfecta Foundation Oxalosis & Hyperoxaluria Foundation Parent Project Muscular Dystrophy PBCers Organization PCa Blue Inc. PFO Research Foundation PKD Foundation PMG Awareness Organization Prevent Cancer Foundation PTEN Hamartoma Tumor Syndrome Foundation Pulmonary Fibrosis Advocates PXE International Rally Foundation for Childhood Cancer Research Rare and Undiagnosed Network (RUN) Rare Disease United Foundation Rare NY RASopathies Network Regenerative Medicine Foundation Research!America RetireSafe Rhode Island Ehlers Danlos Syndrome Awareness and Support Rush to Live Organization RYR-1 Foundation Sarcoidosis of Long Island Sarcoma Foundation of America Shwachman-Diamond Syndrome Foundation Sjögren's Syndrome Foundation Smashing Walnuts Foundation Solve ME/CFS Initiative Spina Bifida Association SSADH Association St. Baldrick's Foundation Taylor's Tale The AIDS Institute The ALS Association The Association for Frontotemporal Degeneration (AFTD) The Atypical HUS Foundation The Choroideremia Research Foundation, Inc. The Global Foundation for Peroxisomal Disorders The Kortney Rose Foundation The LAM Foundation The Mastocytosis Society The Michael J. Fox Foundation The Nicholas Conor Institute Tourette Association of America Tremor Action Network Trisomy 18 Foundation, Inc. United Leukodystrophy Foundation United Spinal Association US Pain Foundation Usher 1F Collaborative Usher 2020 Foundation Usher Syndrome Coalition Wake Up Narcolepsy Wellness Warrior Foundation ### Read More

Associations Representing Over 200 Research Universities Call for #CuresNow

2016/11/16

WASHINGTON, DC – The nonpartisan support for the 21st Century Cures Act continues to grow stronger by the day. In recent weeks, letters of support have come from Research!America and United for Medical Research, and One Voice Against Cancer. Most recently, the Association of Public & Land-Grant Universities (APLU) and the Association of American Universities (AAU) wrote expressing their continued support of the nonpartisan Cures bill. “On behalf of our associations’ more than 200 research universities, we respectfully urge Congress to pass and send to the president this year a 21st Century Cures/medical innovation bill which provides a surge of multi-year, guaranteed funding as well as robust authorization levels for the National Institutes of Health (NIH),” wrote Peter McPherson, President of APLU, and Mary Sue Coleman, President of AAU. “The House and Senate’s bipartisan efforts on such legislation in the 114th Congress have been truly extraordinary and should not go unfulfilled.” In the letter to bipartisan House and Senate leaders, the two groups urge advancing the bill before the end of the year, writing, “…we strongly encourage you to seize this notable opportunity and move an NIH Cures/innovation bill over the finish line.” Lists of APLU and AAU members are below. APLU members: Alabama A & M University Alcorn State University American Samoa Community College Arizona State University Arkansas State University (Jonesboro) Association of Canadian Faculties of Agriculture and Veterinary Medicine (ACFAVM) Auburn University Main Campus Augusta University (formerly Georgia Regents University) Ball State University Boise State University Bowling Green State University-Main Campus California Polytechnic State University-San Luis Obispo California State University System California State University, Fresno California State University, Fullerton California State University, Northridge California State University, Sacramento Central State University Clemson University Cleveland State University College of William and Mary Colorado School of Mines Colorado State University Colorado State University System Connecticut Ag. Experiment Station Cornell University CUNY City College CUNY System Dalhousie University Delaware State University East Carolina University Florida Agricultural and Mechanical University Florida Atlantic University Florida International University Florida State University Fort Valley State University George Mason University Georgia Institute of Technology-Main Campus Georgia Southern University Georgia State University Idaho State University Illinois State University Indiana University-Bloomington Indiana University-Purdue University-Indianapolis Instituto Politécnico Nacional Iowa State University Jackson State University Kansas State University Kent State University Kent Campus Kentucky State University Langston University Lincoln University Louisiana State University and A&M College Louisiana Tech University Massachusetts Institute of Technology Miami University-Oxford Michigan State University Michigan Technological University Middle Tennessee State University Mississippi State University Missouri University of Science and Technology (formerly U of Missouri Rolla) Montana State University Montclair State University Morgan State University National Autonomous University of Mexico (UNAM) National Organization of Research Development Professionals New Jersey Institute of Technology New Mexico State University-Main Campus North Carolina A & T State University North Carolina State University at Raleigh North Dakota State University-Main Campus Northern Arizona University Northern Illinois University Oakland University Ohio State University-Main Campus Ohio University-Main Campus Oklahoma State Regents for Higher Education Oklahoma State University-Main Campus Oregon State University Pennsylvania State University-Main Campus Portland State University Prairie View A & M University Purdue University-Main Campus Queen's University Rutgers University-New Brunswick San Diego State University San Francisco State University South Carolina State University South Dakota State University Southern Illinois University Carbondale Southern Illinois University System Southern University and A & M College Southern University System Stony Brook University SUNY at Albany SUNY at Binghamton SUNY State University of New York (System) Temple University Tennessee State University Texas A & M University Texas A&M University System Texas State University (formerly Texas State University-San Marcos, Southwest Texas State) Texas Tech University Texas Tech University System The Mississippi Board of Trustees of State Institutions of Higher Learning The University of Alabama The University of British Columbia The University of Montana The University of Tennessee The University of Tennessee (system) The University of Texas at Arlington The University of Texas at Austin The University of Texas at Dallas The University of Texas at El Paso The University of Texas at San Antonio Tuskegee University United States Naval Academy Universidad Autónoma de Nuevo León Universidad de Guadalajara Universidad Veracruzana University at Buffalo University of Akron Main Campus University of Alabama at Birmingham University of Alabama in Huntsville University of Alabama System University of Alaska Fairbanks University of Alaska Statewide System University of Alberta University of Arizona University of Arkansas at Pine Bluff University of Arkansas Main Campus University of Calgary University of California System University of California, Merced University of California-Berkeley University of California-Davis University of California-Irvine University of California-Los Angeles University of California-Riverside University of California-San Diego University of California-Santa Barbara University of California-Santa Cruz University of Central Florida University of Cincinnati-Main Campus University of Colorado at Boulder University of Colorado Denver University of Colorado System University of Connecticut University of Delaware University of Florida University of Georgia University of Guam University of Guelph University of Hawaii at Manoa University of Hawaii System University of Houston University of Idaho University of Illinois at Chicago University of Illinois at Urbana-Champaign University of Illinois System University of Iowa University of Kansas University of Kentucky University of Louisiana at Lafayette (formerly U of SW Louisana) University of Louisville University of Maine University of Maryland Eastern Shore University of Maryland-Baltimore County University of Maryland-College Park University of Maryland-University College University of Massachusetts Amherst University of Massachusetts System University of Massachusetts-Boston University of Massachusetts-Dartmouth University of Massachusetts-Lowell University of Memphis University of Michigan-Ann Arbor University of Minnesota-Duluth University of Minnesota-Twin Cities University of Mississippi Main Campus University of Missouri (System) University of Missouri-Columbia University of Missouri-Kansas City University of Missouri-St Louis University of Nebraska (System) University of Nebraska-Lincoln University of Nevada-Las Vegas University of Nevada-Reno University of New Hampshire-Main Campus University of New Mexico-Main Campus University of New Orleans University of North Carolina (System) University of North Carolina at Chapel Hill University of North Carolina at Charlotte University of North Carolina at Greensboro University of North Carolina-Wilmington University of North Dakota University of North Texas University of Oklahoma Norman Campus University of Oregon University of Pittsburgh-Pittsburgh Campus University of Puerto Rico-Mayaguez University of Rhode Island University of Saskatchewan University of South Alabama University of South Carolina-Columbia University of South Dakota University of South Florida University of Southern Mississippi University of Texas System University of the District of Columbia University of the Virgin Islands University of Toledo University of Utah University of Vermont University of Virginia-Main Campus University of Washington-Seattle Campus University of Western Ontario University of Wisconsin System University of Wisconsin-Extension/University of Wisconsin Colleges University of Wisconsin-Madison University of Wisconsin-Milwaukee University of Wyoming University System of Georgia University System of Maryland Utah State University Virginia Commonwealth University Virginia Polytechnic Institute and State University Virginia State University Washington State University Wayne State University West Virginia State University West Virginia University Western Michigan University Wichita State University Wright State University-Main Campus AAU members: Boston University Brandeis University Brown University California Institute of Technology Carnegie Mellon University Case Western Reserve University Columbia University  Cornell University  Duke University Emory University Georgia Institute of Technology Harvard University  Indiana University Iowa State University The Johns Hopkins University  Massachusetts Institute of Technology McGill University Michigan State University New York University  Northwestern University The Ohio State University The Pennsylvania State University Princeton University  Purdue University Rice University Rutgers University-New Brunswick Stanford University  Stony Brook University-The State University of New York Texas A&M University Tulane University The University of Arizona University at Buffalo, The State University of New York University of California, Berkeley  University of California, Davis University of California, Irvine University of California, Los Angeles University of California, San Diego University of California, Santa Barbara The University of Chicago  University of Colorado Boulder University of Florida University of Illinois at Urbana-Champaign The University of Iowa The University of Kansas University of Maryland, College Park University of Michigan  University of Minnesota, Twin Cities University of Missouri-Columbia The University of North Carolina at Chapel Hill University of Oregon University of Pennsylvania  University of Pittsburgh University of Rochester University of Southern California The University of Texas at Austin University of Toronto University of Virginia University of Washington  The University of Wisconsin-Madison  Vanderbilt University  Washington University in St. Louis Yale University ### Read More

#SubCommTech and #SubCMT Examine Recent Cyber Attacks

2016/11/16

[[{"fid":"1818","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","attributes":{"height":"204","width":"333","class":"media-element file-full"},"link_text":null}]] WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Greg Walden (R-OR), and the Commerce, Manufacturing, and Trade Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the recent series of Internet of Things (IoT) connected device-based distributed denial of service (DDoS) attacks. Last month hackers leveraged a DDoS attack against global Internet routing company Dyn that resulted in thousands of consumers being unable to connect with Netflix, Twitter, CNN, and other well-known websites. It’s estimated that 50 billion devices will be connected to the Internet by 2020 and as this number grows, so too do the risks. While technology presents a host of benefits for both consumers and businesses across a variety of sectors such as health care, energy, education, transportation, and agriculture, unsecured devices on the network present a number of entry points for hackers and malicious actors to disrupt vital communications. Members continued the committee’s long track record of examining emerging cybersecurity threats and their impact on consumers and the economy while looking at what can be done to mitigate future attacks and risks. In his testimony, Dale Drew, Senior Vice President and Chief Security Officer at Level 3 Communications, discussed the importance of a collaborative approach to address IoT security risks, stating, “Bad actors are increasingly attracted to IoT devices since they can use those devices without being detected for long periods of time, they know most devices will not be monitored or updated, and they know there are no endpoint protection capabilities on IoT devices to remove threats. … Network operators, device manufacturers and users will need to remain vigilant to the security risk these devices present. … It will be imperative for all relevant stakeholders to continue to work collaboratively to address and mitigate IoT security risks so that we can reap the benefits of this exciting and transformative technology.”  [[{"fid":"1820","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","attributes":{"height":"200","width":"261","class":"media-element file-full"},"link_text":null}]] In his questioning, Chairman Walden asked the witnesses for their opinion when it comes to drafting potential cybersecurity standards while not stifling innovation, asking, “How do we create a national framework where the stakeholders are really driving this in real time…and where we don’t lock certain requirements into statute?” Dr. Kevin Fu, CEO of Virta Labs and Associate Professor in the Department of Electrical Engineering and Computer Science at the University of Michigan, responded, “There are ways you can do this effectively without stifling innovation. In fact, I believe a well-designed cyber security framework will actually promote innovation… There is no perfect standard but it will be very difficult to build in security if we don’t have these principles set in place. It needs to have buy-in from industry. It needs to have government leadership as well but it’s all about setting those principles.” Chairman Burgess noted the importance of leadership from industry, stating, “The balance between functionality and security is not going to be resolved in the near term. The culture surrounding personal cybersecurity must change to ensure the Internet of Things is not vulnerable to a single device. Government is never going to have the man power or resources to address all of these challenges as they come up – which is why we need industry to take the lead.” “How do we make ourselves more secure without sacrificing the benefits of innovation and technological advances? The knee-jerk reaction might be to regulate the IoT, and while I am not taking that off the table, the question is whether we need a more holistic approach,” concluded Chairman Walden. “Any sustainable and effective solution will require input from all members of the ecosystem for the so-called “Internet of Things.” We’ll need a concerted effort to improve not only device security, but also coordinate network security and improve the relationships between industry, government, and security researchers. We’re all in this together and will need to take responsibility for securing the Internet of Things.” For more information on today’s hearing, including a background memo, and archived webcast, click HERE.  Read More

Research Leaders: Delivering #CuresNow “will make a real difference in the life of every American”

2016/11/16

WASHINGTON, DC – Leaders of the group, United for Medical Research took to The Hill to explain why passing the 21st Century Cures Act during the lame duck wouldn’t be so “lame.” The authors, Marc N. Casper, Mary Sue Coleman, and Chris Hansen, lead Thermo Fisher Scientific, the Association of American Universities, and the American Cancer Society Cancer Action Network, respectively. Together, Casper, Coleman, and Hansen, wrote, “Cures is about improving health, saving lives and, most importantly, offering hope to people affected by disease. Significant among its provisions is a one-time funding surge for the National Institutes of Health (NIH), which would help the nation’s premier health research agency catch up from more than a decade of flat funding and ensure that the United States remains the world’s engine for medical innovation.” [[{"fid":"1816","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"165","width":"163","class":"media-element file-full"}}]] November 14, 2016 There’s nothing ‘lame’ about passing Cures bill Members of Congress return to Washington this week with a rare opportunity to come together to put the divisiveness of the recent campaign behind them and pass legislation that will make a real difference in the life of every American. The 21st Century Cures Act is that opportunity. Cures is about improving health, saving lives and, most importantly, offering hope to people affected by disease. Significant among its provisions is a one-time funding surge for the National Institutes of Health (NIH), which would help the nation’s premier health research agency catch up from more than a decade of flat funding and ensure that the United States remains the world’s engine for medical innovation. This is important. While NIH funding has remained flat for nearly a decade and a half, the opportunities before us to prevent, treat and cure our most vexing diseases have grown exponentially. As NIH Director Dr. Francis Collins has said, “Our nation has never witnessed a time of greater promise in biomedicine.” The confluence of genomics, nanotechnology and breathtakingly powerful computational and analytical tools has opened doors to advances that, until recently, were unimaginable.  Our organizations are part of United for Medical Research (UMR), which recently highlighted examples of truly groundbreaking innovations that are on the cusp of saving lives and saving healthcare dollars. These include a bionic pancreas that provides fully automated, 24/7 blood sugar maintenance for people with type 1 diabetes; a low-cost, minimally invasive test that can identify cancer before it’s visible; a bio-artificial kidney that can alleviate the need for dialysis in people with renal failure; cancer-illuminating goggles that enable surgeons to see and remove all traces of cancer; and a new approach for developing a potential treatment for Duchenne muscular dystrophy. Not one of these amazing things would be where it is today without NIH research funding.  Unfortunately, demand for NIH funding far outstrips supply. For every single research proposal funded by the NIH, there are more than four others that go unfunded. While it may be impossible to measure the potential cures lost when worthy research proposals go unfunded, there is no doubt that funding additional research focused on preventing, treating and curing our most chronic and costly diseases would have a significant impact on the U.S. economy.  Each year the Centers for Medicare and Medicaid Services spends around $35 billion to care for people with end-stage renal failure — an amount greater than the entire NIH budget. Nearly 1 in every 5 Medicare dollars is spent on individuals with Alzheimer’s disease or other forms of dementia. Alzheimer’s is the sixth-leading cause of death in the United States and the only cause of death among the top 10 that cannot be prevented, cured or even slowed. And it is estimated that a 1 percent reduction in death from cancer or heart disease would be worth nearly $500 billion to the economy. The 21st Century Cures Act passed by an overwhelming and bipartisan majority of the House in 2015. Bipartisan leaders in the Senate spent much of this year fine-tuning their version of the legislation. Now is the time to act.  It might just be that passing legislation intended to offer hope is exactly what America needs right now. There could be no better legacy for the 114th Congress.   Click HERE to read the column online. ### Read More

Understanding the Role of Connected Devices in Recent Cyber Attacks

2016/11/16

[[{"fid":"1814","view_mode":"full","fields":{"format":"full"},"type":"media","link_text":null,"attributes":{"alt":"Understanding the Role of Connected Devices in Recent Cyber Attacks","height":"380","width":"640","class":"media-element file-full"}}]] Read More

DISRUPTER SERIES: #SubCMT Explores Potential of Self-Driving Vehicles

2016/11/15

[[{"fid":"1811","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"3648","width":"5472","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] WASHINGTON, DC – The Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing as part of the ongoing Disrupter Series to examine the potential of self-driving cars. The hearing provided an opportunity to better understand how this innovative technology is improving the quality of life, changing the public safety landscape, and improving mobility for underserved populations. Members also examined the regulatory process in place and how it could be clarified so that autonomous vehicle innovation is not comprised. A primary theme throughout the hearing was focused on the promise that autonomous vehicles hold in improving motor vehicle safety, preventing accidents, and reducing fatalities. Mitch Bainwol, President and CEO of the Alliance of Automobile Manufacturers, testified, “Because of the innovations that automakers are introducing, technologies are increasingly able to help address the 99 percent of roadway fatalities that are mostly a product of human behavioral issues – such as speeding, alcohol impairment, failure to use a seat belt, and distraction – as well as environmental factors and infrastructure limitations.” Echoing similar sentiments, Dr. Mark Rosekind, Administrator for the National Highway Traffic Safety Administration, stated, “[W]hile automated vehicles carry enormous potential to transform mobility, reshape our transportation system and transform our economy, it is their awesome potential to revolutionize roadway safety that has us so motivated.” During his testimony, Dr. Rosekind reiterated that 94 percent of crashes “can be tied back to human choice or error.” Another key benefit of autonomous vehicles discussed among members is the range in mobility provided to the elderly or underserved populations. Kirk T. Steudle, Director of Michigan Department Transportation, honed in on the specific benefits of self-driving cars in Michigan, commenting, “My state has one of the oldest populations in the country, with 14 percent of residents being 65 or older in the 2010 census. I am thrilled at the prospect of automakers in Michigan leading in developing technology that will give those people mobility options.” [[{"fid":"1812","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"3309","width":"4965","style":"width: 450px; height: 300px;","class":"media-element file-full"}}]] Chairman Burgess checks out Tesla’s Model X during the self-driving car demonstration held prior to today’s hearing. Another poignant component of today’s hearing was for members to discuss the Federal Automated Vehicles Policy guidance issued by the National Highway Safety Administration (NHTSA) in September. Chairman Burgess commented, “I think NHTSA’s recent guidance is well meaning. But I do worry greatly about its implementation. Waiting for the government to approve technology is never a good formula. That said we must remain vigilant in areas, like cybersecurity, where industry must be held accountable if they are not taking reasonable measures.” Witnesses also cited both concerns and encouraging aspects of NHTSA’s recent automated vehicle guidance. Gary Shapiro, President and CEO of Consumer Technology Association, stated, “Other encouraging aspects of the NHTSA guidance include several suggestions for states to expand testing and operating opportunities for manufacturers. The guidance encourages states to evaluate and update current laws so as not to impede testing or operation of self-driving vehicles – e.g. human driver references in current law should be updated.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. Read More

Upton & Walden Urge FCC Regulatory Freeze

2016/11/15

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI) and Communications and Technology Subcommittee Chairman Greg Walden (R-OR) today sent a letter to Federal Communications Commission (FCC) Chairman Tom Wheeler regarding possible FCC decisions during the presidential transition. Upton and Walden write: The most important challenge for the Commission over the next ten weeks is to ensure a successful broadcast incentive auction. The successful completion of the auction will provide needed spectrum to meet Americans wireless broadband needs and ensure that Americans continue to enjoy the local news and national programming broadcasters provide. As Rep. Henry Waxman and Senator Jay Rockefeller noted during the 2008 Presidential transition, it would be counterproductive for the FCC to consider complex and controversial items that the new Congress and new Administration will have an interest in reviewing. We strongly urge you to concentrate the Commission's attention and resources only on matters that require action under the law and efforts to foster the success of the broadcast incentive auction. To read the letter online, click here. ###  Read More

Letter to FCC Chairman Tom Wheeler Regarding Regulatory Freeze

2016/11/15

Excerpt: "We strongly urge you to concentrate the Commission's attention and resources only on matters that require action under the law and efforts to foster the success of the broadcast incentive auction." To read the letter, click here. Read More

Committee Leaders Comment on Administration’s Latest Emissions Regulations

2016/11/15

WASHINGTON, DC – Energy and Commerce Committee Chairman Fred Upton (R-MI), Energy and Power Subcommittee Vice Chairman Pete Olson (R-TX), and Environment and the Economy Subcommittee Chairman John Shimkus (R-IL) today issued the following statement after the Interior Department issued new rules regulating methane emissions from existing oil and gas wells. “The administration is now in overdrive, furiously working to cement Obama’s climate agenda as the clock ticks on his presidency,” said Upton, Olson, and Shimkus. “This unnecessary Interior rule is a perfect example – and it will raise the price of energy, discourage innovation, and cost more jobs. The good news is the days are numbered for such backward policies. Looking forward, House Republicans have a better way when it comes to protecting our natural resources and saying yes to affordable, reliable energy, and yes to jobs.” ###  Read More

#CuresIn4Words: Press Play For Cures

2016/11/15

The EveryLife Foundation for Rare Diseases is out with a new video featuring rare disease patients who shared their photos and personalized messages of why they need #CuresNow – the result of the organization’s multi-month campaign. Viewers might recognize the song playing in the background. It’s “Clouds,” by Zach Sobiech. Zach lost his battle with osteosarcoma, a rare form of cancer, at the age of 18. His song became an instant Internet sensation, debuting on Billboard’s Hot 100 at number 26, one week after Zach’s passing. [[{"fid":"1809","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"226","width":"405","class":"media-element file-full"}}]] Click HERE to watch EveryLife’s new video. The video shares some statistics about those battling rare diseases. Among them: one in 10 Americans have a rare disease, and 30 percent of children battling rare disease won’t live to see their fifth birthday. But for these patients and their families, there is hope. The 21st Century Cures Act will provide the necessary resources to researchers to continue their critical efforts to uncover the next generation of cures and treatments. “Cures could dramatically increase the number of treatments for rare disease patients,” the video explains. “A delay in legislation is a delay in life-saving treatments,” the video continues. “We need #CuresNOW.” Click HERE to watch the video. ### Read More

Rep. Steve LaTourette’s Widow Urges #CuresNow: “It’s time to stop waiting and start saving lives”

2016/11/15

[[{"fid":"1807","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"600","width":"900","style":"width: 500px; height: 333px;","class":"media-element file-full"}}]] WASHINGTON, DC – 21st Century Cures delivers more than hope to patients and families across the country. New discoveries in science and technology have the potential to provide researchers, doctors, and patients the tools they need to overcome even the deadliest diseases. The push for #CuresNow has only intensified as more and more families wait for cures that could save their loved-one’s life. Former Rep. Steve LaTourette (R-OH), a fierce believer in bipartisan cooperation during his time in office, lost his battle with pancreatic cancer in August of this year. His widow, Jennifer LaTourette, took to The Hill to express the importance of getting #CuresNow to the finish line, writing, “There are few challenges we face as a country that are as critical as the challenge of determining the best approach for investments in life-saving and life-extending medical research. … This bill wouldn't have saved Steve's life, but it most certainly can save the lives of others in the future.” November is Pancreatic Cancer Awareness Month, another opportunity to call for #CuresNow. “…Congress has a short window of opportunity to show voters that they have heard them loud and clear and move this vital legislation. Sitting on the sidelines is not an option, we need the White house and members on both sides of the aisle and in both chambers to act. It is time to stop waiting and to start saving lives,” concluded LaTourette. [[{"fid":"1806","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"136","width":"166","class":"media-element file-full"}}]] We can’t wait on medical cures By Jennifer LaTourette Waiting is a part of life. We wait in line at the DMV, we wait for a table at a restaurant. We wait for the elusive cable repair guy to show up at sometime between 8 a.m. and 3 p.m. Waiting often can't be avoided. During my husband's battle with pancreatic cancer, waiting, however, became more than just an inconvenience. Waiting became an agonizing but unavoidable part of the fight. Waiting for test results to reveal whether or not the cancer had spread. Waiting to find out whether the chemo was working. Waiting to determine whether or not he would be healthy enough for more treatment. Waiting - in the end - for the awful moment when the suffering would end. Waiting has certainly become part of today's legislative process - or what passes for a legislative process. We wait until the last minute to pass a continuing resolution to avoid a government shut down. We wait on even the most mundane and rudimentary jobs of Congress to be performed because the process has been paralyzed by partisanship. We wait on passing critical legislation - even when it has wide bipartisan support - because waiting is just what we do in Washington now. And while there are times we understand that waiting is simply a part of the process; there are other times when the stakes are too high to simply accept needless delay. Sometimes, and for some people, waiting is more than just an inconvenience; it can be the difference between life and death. Last year, spurred on - in part - by the tragic death of Vice President Biden's son, the issue of our government's role in finding cures for cancer and other life-threatening diseases took center stage on the Hill and in the media. House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), joined by his colleague, Rep. Diana DeGette (D-Colo.), shepherded the 21st Century Cures Act through the House. In a rare show of bipartisanship, the House voted by an overwhelming 344 to 77 to pass the bill intended to spur the discovery of medical cures and to speed their deliver to patients in need. After passage in the House, the bill's cosponsors released a statement saying, "today, we took a big leap on the path to cures, but we still have much work left to do." Fifteen months later and we are still waiting. Frankly, this is simply unacceptable. Upton and DeGette have been tireless in their efforts to get this critical piece of legislation across the finish line. Now it is time for others to pitch in and make sure that part of this Congress' legacy is a real commitment to saving lives. When my husband retired from Congress, after serving 18 years representing the people of northeastern Ohio, he cited the growing paralyzing partisanship as the primary motivating factor in his decision. In a 2013 op-ed, Steve wrote, "Running for office is not an obligation; one isn't forced to do it. And those lucky enough to be entrusted with the faith of the voters they were elected to represent have obligations that come with the office. Our nation faces serious challenges. We need men and women in Congress who are willing to get to work finding solutions. Sitting on the sidelines is not an option." There are few challenges we face as a country that are as critical as the challenge of determining the best approach for investments in life-saving and life-extending medical research. Steve was blessed to have had access to the absolute best doctors in the country and some of the most cutting edge medical technology that exists today. This bill wouldn't have saved Steve's life, but it most certainly can save the lives of others in the future. … When they return next week, Congress has a short window of opportunity to show voters that they have heard them loud and clear and move this vital legislation. Sitting on the sidelines is not an option, we need the White House and members on both sides of the aisle and in both chambers to act. It is time to stop waiting and to start saving lives. Click HERE to read the full op-ed online.   ###  Read More

Disrupter Series: Self-Driving Cars

2016/11/15

[[{"fid":"1808","view_mode":"full","fields":{"format":"full"},"type":"media","link_text":null,"attributes":{"alt":"Disrupter Series: Self-Driving Cars","height":"380","width":"640","class":"media-element file-full"}}]] Read More

#RECORDOFSUCCESS: 8 More Clear the Floor

2016/11/14

[[{"fid":"1801","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"300","width":"579","class":"media-element file-full"}}]] WASHINGTON, DC – Building on the Energy and Commerce Committee’s bipartisan #RecordOfSuccess, the House of Representatives today advanced eight committee bills. To date, over 130 bipartisan Energy and Commerce bills and provisions have cleared the House – and that number continues to grow with Congress back in session. “We are proud of our bipartisan Record of Success which has steadily grown over the course of the 114th Congress, and today we had eight more clear the House floor,” said full committee Chairman Fred Upton (R-MI). “Collectively, these bills advance ongoing efforts to protect consumers from bad actors, improve call quality for folks living in rural areas, boost investment into outdoor recreation, and improve the public health of Americans by better coordinating care. With the return of Congress, our work continues.” The bills passed by the House today include: #SubCommTech: H.R. 2669, the Anti-Spoofing Act of 2015, introduced by Rep. Grace Meng (D-NY) and co-authored by Rep. Leonard Lance (R-NJ) and Rep. Joe Barton (R-TX), would strengthen the Truth In Caller ID Act and protect consumers from fraudulent actors and deceptive text messages by going after lawbreakers who seek to harass and defraud consumers. H.R. 2669 passed 382 to 5. H.R. 2566, the Improving Rural Call Quality and Reliability Act of 2016, introduced by Rep. David Young (R-IA), would require intermediate providers to register with the Federal Communications Commission and comply with the service quality standards set by the agency in order to improve call quality from long distance or wireless calls in rural areas throughout the country. H.R. 2566 passed unanimously by voice vote. #SubCMT: HR. 985, the Concrete Masonry Products Research, Education, and Promotion Act of 2015, authored by Rep. Brett Guthrie (R-KY), would authorize the establishment of a federal “check-off” program for concrete masonry products. “Check-off” programs, which are financed by industry and overseen by the appropriate federal agency, are used to boost the overall sales and production of a particular commodity or good without reference to a specific brand or producer and also helps support jobs. H.R. 985 passed 355 to 38. H.R. 4665, the Outdoor REC Act of 2016, authored by Rep. Don Beyer (D-VA), would  direct the Department of Commerce to conduct an assessment and analysis of the outdoor recreation economy to ensure that it is measured and accounted for by the federal government as part of the country’s GDP.  This analysis will inform federal and state lawmakers on recreation policy and assist their efforts to optimize business investments into the outdoor recreation industry, which has become a significant driver of economic growth and job creation in the United States. H.R. 4665 passed unanimously by voice vote. #SubHealth: H.R. 1192, the National Clinical Care Commission Act, authored by Rep. Pete Olson (R-TX), would establish a National Clinical Care Commission to evaluate and recommend solutions regarding better coordination and use of federal programs relating to supporting care for people with metabolic syndromes and related autoimmune disorders. H.R. 1192 passed unanimously by voice vote. H.R. 1209, the Improving Access to Maternity Care Act, introduced by Rep. Michael C. Burgess, M.D. (R-TX), increases data collection by HHS to help place maternal health professionals in more appropriate geographic regions through their existing participating in the National Health Service Corps (NHSC). There is no new authorization of appropriations for this bill nor does it expand participation in the NHSC. H.R. 1209 passed unanimously by voice vote. H.R. 2713, the Title VIII Nursing Workforce Reauthorization Act of 2015, introduced by Rep. Lois Capps (D-CA), reauthorizes grants and scholarships for graduate and undergraduate nursing education in specified areas of nursing. The legislation also amends the PHSA to include clinical nurse leaders as advanced education nurses making clinical nurse leader education programs eligible for advanced education nursing grants. H.R. 2713 passed unanimously by voice vote. H.R. 4365, the Protecting Patient Access to Emergency Medications Act of 2016, introduced by Rep. Richard Hudson (R-NC), would improve the Drug Enforcement Administration registration process for emergency medical services (EMS) agencies and clarify that EMS professionals are permitted to administer controlled substances pursuant to standing or verbal orders when certain conditions are met. H.R. 4365 passed unanimously by voice vote. To learn more about the committee’s #RecordOfSuccess, click HERE.  Read More

Automated Vehicle Technology Demonstration

2016/11/14

WASHINGTON, DC – Ahead of Tuesday’s Commerce, Manufacturing, and Trade Subcommittee hearing on “Disrupter Series: Self-Driving Cars,” several automakers will be demonstrating automated vehicle technologies from 9 a.m. to 10:30 a.m. The hearing will commence at 10:30 a.m. in room 2322 of the Rayburn House Office Building. Note: This event is open to participating members, staff, and accredited members of the media.  WHO: Vehicles from Tesla Motors, BMW Group, and Audi of America, Inc. will be present for static demonstrations and/or test-drives. WHAT: Automated vehicle technology demonstration WHEN: 9 a.m. to 10:30 a.m. on Tuesday, November 15, 2016 WHERE: On the House Campus: South Capitol Street, SE, between C Street, SE and D Street, SE   Read More

Washington Post: Congress Can Save Lives with #CuresNow

2016/11/14

WASHINGTON, DC – As Congress reconvenes today, momentum for the 21st Century Cures Act continues. The nonpartisan effort seeks to accelerate the discovery, development, and delivery of new cures and treatments. Over the weekend, The Washington Post’s editors called on Congress to get the job done, saying, “it would be a valuable use of Congress’s time” to pass 21st Century Cures during the lame duck session. “The act, a version of which passed in the House last year, proposes a one-time, multibillion-dollar increase in funding for the National Institutes of Health. The money could provide a sharp boost to the Obama administration’s cancer initiative, or to research into precision medicine, which tailors treatments to people’s genomes. Rapid progress in both is possible and could save many lives…,” wrote The Washington Post. [[{"fid":"1800","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"77","width":"405","class":"media-element file-full"}}]] November 12, 2016 EDITORIAL: How should Congress use its lame-duck session? First, it can save lives. Republicans are signaling that they will pursue an ambitious conservative agenda when they take the reins of government next year. But before that happens, the current Congress will convene in its lame-duck session, valuable legislative time that Senate Majority Leader Mitch McConnell (R-Ky.) said this week he hopes to put to good use. The session may be consumed by arguments over federal budgeting. But if there is time for anything else, Mr. McConnell may push the 21st Century Cures Act, a bipartisan effort that has taken years to get close to passing. Congress should nudge it across the finish line — taking care to repair a few problems along the way. The act, a version of which passed in the House last year, proposes a one-time, multibillion-dollar increase in funding for the National Institutes of Health. The money could provide a sharp boost to the Obama administration’s cancer initiative, or to research into precision medicine, which tailors treatments to people’s genomes. Rapid progress in both is possible and could save many lives; new cancer drugs have emerged targeting specific mutations in tumor cells, and they have shown encouraging initial results in treating even some of the most complex cancers. The new funding could also go into competitive grants for scientists with particularly innovative projects that are nevertheless underfunded. Given that so many lifesaving pharmaceuticals have their origins in government-sponsored scientific research, the funding boost would be a good investment. The new money alone, however, would struggle to attract strong bipartisan backing. So lawmakers linked it to various reforms of the Food and Drug Administration’s approval process, arguing that the agency has been hamstrung in getting new drugs to market. One reform on the table would adjust hiring standards at the FDA, which is perpetually short-staffed. The agency has improved on the time it takes to approve new medications, but a more flexible hiring policy could help further. There are also worthwhile provisions that would give gravely sick patients with few options easier access to experimental medication. … Read the full editorial online HERE ### Read More

Cubbies Friendship Swings for the Fences

2016/11/12

WASHINGTON, DC – After 108 years, “it finally happened” for Cubs fans. And for one special young fan, he got to watch his friend and hero, Cubs slugger Kyle Schwarber deliver in the clutch. But what makes this story particularly special, is that the young fan is one of Schwarber’s own heroes. Meet 10-year-old Campbell Faulkner of Arizona. Faulkner has a rare form of mitochondrial disease that makes it difficult for him to walk or stand for long periods of time. The genetic disease also requires he be hooked up to tubes for feeding and waste removal. [[{"fid":"1797","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"221","width":"307","class":"media-element file-full"}}]] Meet Campbell Faulkner and Kyle Schwarber, each other’s heroes. After meeting Schwarber at spring training in March 2015, Campbell’s mom recalls their family waiting after the game to see if any players would sign autographs. She recounts to USA Today, “…Kyle stuck around and gave autographs to every single person.” It was then that Schwarber signed a baseball for Faulkner, and received a green wristband in return. [[{"fid":"1798","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"234","width":"350","class":"media-element file-full"}}]] Schwarber wearing the green wristband from Faulkner during the World Series. The two discussed baseball, and how Campbell was doing. The two decided to keep in touch via email. Schwarber planned a special day of surprises for Faulkner for his birthday. Schwarber gave some tips with his batting stance, something Faulkner was able to put into use in a special baseball league he plays in. And when the tables turned and Schwarber was injured, you better believe Faulkner was there for him – in the stands too! “My surgeon can put you back together and my physical therapist can help your muscles get strong again,” Campbell’s mother recalls him writing to his beloved slugger. Schwarber’s road ahead looked long, but he did the unthinkable – coming back from reconstructive knee surgery just months ago and playing in the World Series. “I know he likes to say I’m his inspiration,” Schwarber told USA Today. “Really, if you want to know the truth, he’s my inspiration.” “No one believed he could do it. But I kept praying for him. I kept sending letters each week, telling him he could do it,” Faulkner commented after World Series Game 2. “Now that he’s done it, I can do it, too, right? He gives me hope.” “Kyle told me that we’re in the World Series together. We made it,” said Faulkner. The rest is history. As the city of Chicago and fans across the country continue to #FlyTheW, we’re still cheering for Cures. Patients like Campbell Faulkner need #CuresNow. [[{"fid":"1799","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"70","width":"288","class":"media-element file-full"}}]] A hero’s hero: Kyle Schwarber moved by plight of 10-year-old The letters would arrive every week in his mailbox at Wrigley Field. Chicago Cubs slugger Kyle Schwarber would carefully open the envelope, slowly read the message and try not to cry. Sometimes, Schwarber would even wait to open it, saving them for the darkest times, when he needed him the most. “There were plenty of those times,” Schwarber said Thursday, “but he was always there for me. “Always.” Schwarber tries to envision the atmosphere Friday night during introductions before Game 3 of the World Series when Wrigley Field plays host to a World Series game for the first time in 71 years. He will look around the stands, perhaps seeing if he can locate his family, while the sellout crowd and national TV audience spots his bright green wristband, the one he has worn for two years in honor of his friend. “I know he likes to say I’m his inspiration,” Schwarber said. “Really, if you want to know the truth, he’s my inspiration.” The name is Campbell Faulkner, who lives with his parents in Queen Creek, Ariz. He is 10 years old. Faulkner is 4-11, weighs 64 pounds, always engaged with an oxygen tank, cough and suction machines and a team of 13 doctors trying to find a cure for a rare form of mitochondrial disease. This is the boy who’s Schwarber’s hero. And this is the young man who’s Faulkner’s inspiration. Click HERE to read the full story. ### Read More

Look Ahead: Committee Announces Hearing Schedule for the Week of November 14

2016/11/10

[[{"fid":"1796","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"219","width":"329","class":"media-element file-full"}}]] WASHINGTON, DC – The House Committee on Energy and Commerce today announced its hearing schedule for the week of November 14. On Tuesday, the Subcommittee on Commerce, Manufacturing and Trade will continue its Disrupter Series with a hearing to examine self-driving cars. The subcommittee will explore the potential impact of self-driving cars on driver and roadway safety and how this emerging technology could improve mobility, increase vehicle efficiency, and create new opportunities including economic growth and transportation access for the disabled and underserved communities. The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. On Wednesday, the Subcommittee on Communications and Technology and the Subcommittee on Commerce, Manufacturing, and Trade will hold a joint hearing to understand the role of connected devices in recent cyber attacks. The subcommittees will examine how Internet of Things (IoT) connected devices are used in cyber attacks to deny access to popular websites or otherwise disrupt online services. The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. Hearing and Meeting Details Tuesday, November 15, 2016 10:30 AM 2322 Rayburn HOB Subcommittee on Commerce, Manufacturing, and Trade Hearing on “Disrupter Series: Self-Driving Cars” Wednesday, November 16, 2016 10 AM 2322 Rayburn HOB Subcommittees on Communications and Technology, Commerce, Manufacturing, and Trade Hearing on “Understanding the Role of Connected Devices in Recent Cyber Attacks” Read More

MCCONNELL: Cures Remains Top Legislative Priority

2016/11/09

WASHINGTON, DC – Senate Majority Leader Mitch McConnell (R-KY) today redoubled his push to see the 21st Century Cures Act, legislation to accelerate the cycle of discovering, developing, and delivering new cures and treatments to patients, signed into law this year. [[{"fid":"1790","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"191","width":"342","class":"media-element file-full"}}]] Watch Senate Majority Leader McConnell’s remarks HERE. “There are two priorities for me for the lame duck. The issue you raised – how are you going to fund the government and second, the 21st Century Cures bill,” said Senate Majority Leader McConnell. “The president’s interested in the precision medicine part of that, the vice president is interested in the cancer moonshot part of it, I’m interested in the regenerative medicine part of it. Sen. Alexander and Chairman Upton have done terrific work on this. I’d like to see us finish that important new measure this year. And the president and I discussed those two matters this morning.” House and Senate leadership highlighted the nonpartisan Cures bill as a top priority before heading into the fall recess. “Our top priority for when Congress returns is getting 21st Century Cures across the finish line,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). “We’ve been working round the clock, and have made important progress on the #Path2Cures. Working together, we have a once in a generation opportunity to do something special for patients. Stay tuned. We will deliver #CuresNow.” ### Read More

HEARING: #SubCommTech & #SubCMT to Examine Recent Cyberattacks NEXT WEEK

2016/11/09

WASHINGTON, DC – The Subcommittee on Communications and Technology, chaired by Rep. Greg Walden (R-OR) and the Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Michael C. Burgess, M.D. (R-TX), have scheduled a joint hearing for Wednesday, November 16, at 10 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Understanding the Role of Connected Devices in Recent Cyber Attacks.” In light of the last month’s cyberattacks against global Internet routing company DYN and the committee’s ongoing work examining emerging cybersecurity issues, next week the subcommittees seek to examine how Internet of Things (IOT) connected devices are used in cyberattacks to deny access to popular websites or otherwise disrupt online services. The committee has a long track record of examining emerging cybersecurity threats and their impact on consumers and the economy. “Internet connectivity remains a vital part of our economic well-being and our national security. Americans should not have to worry that the convenience and connectivity of the Internet of Things comes at the expense of the resiliency and reliability of the larger Internet,” said Walden and Burgess. “Next week’s hearing provides our members with an opportunity to learn more about the recent cyberattacks, how cyberattacks are evolving, and what can be done to mitigate future attacks and risks.” The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted. ###  Read More

Burgess Highlights #SubCMT’s Approach to Put #InnovationFirst

2016/11/09

With 130 bills and provisions through the House, the Energy and Commerce Committee has built a proud bipartisan #RecordOfSuccess. The Commerce, Manufacturing, and Trade Subcommittee has been at the forefront, advancing thoughtful legislation to modernize government for the 21st century, promote innovation and economic growth, and protect consumers. Through the ongoing #DisrupterSeries, the subcommittee has explored emerging technologies and potential solutions to foster continued growth. As #SubCMT Chairman Michael C. Burgess, M.D. (R-TX) highlights in The Washington Times, “…it is critical that the government prioritize flexible solutions that allow for future innovation.” [[{"fid":"1789","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"136","width":"587","class":"media-element file-full"}}]] November 9, 2016 A think tank approach to innovation By #SubCMT Chairman Rep. Michael C. Burgess, M.D. (R-TX) It’s become common practice that federal oversight and regulation emerge following innovation and — more often than not — these regulations can’t keep pace with the technological advances being reached in the private sector. The House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade has spent this Congress exploring ways to foster innovation and growth, while preserving consumer protection and limited government. The Subcommittee has oversight jurisdiction of agencies such as the Federal Trade Commission and the Consumer Product Safety Commission that by nature want to create more regulations and borders for businesses. While it is important for the subcommittee to be aware of what is happening within industry, it is critical that the government prioritize flexible solutions that allow for future innovation. For example, companies employing the e-sharing business model — Uber, Lyft, ThumbTack and others — have thrived under this model of hands-off government. Throughout this Congress, the Commerce, Manufacturing and Trade Subcommittee has adopted a “think tank” approach, serving as a forum for experts to provide thoughtful insights and ideas on specific economic developments, such as the fast-evolving impacts of drone use on consumer business or how the technological advancement in 3D printing have already begun revitalizing the manufacturing industry. Over the last year, the subcommittee has been exploring new, emerging technologies, which have the potential to disrupt a whole host of industries, through a series of hearings, dubbed most appropriately as the “Disrupters Series.” Each technology has been examined under the lens of balancing oversight without bogging down industry with federal overregulation. It has historically been the first instinct of many lawmakers to begin slapping the red tape on new and unfamiliar technologies. Yet, our economy is already benefiting from the current crop of applications in a variety of industries. If we begin applying federal bureaucracy to the innovative work that the private sector is rapidly producing, we risk stifling our country’s growth. And it won’t take long before we are relying on other countries for their technological advancements and insight. In order for American entrepreneurs to thrive, the government must step out of the way. Burdensome regulations handed down by federal government agencies often slow hiring and hurt the bottom line of many small businesses. The phenomenon of 3D printing is enabling a small auto supply business back home in my district to get the job done more efficiently. Painless Performance, in Texas’ 26th Congressional District, now uses a 3D printing prototype service to produce custom wiring harnesses for classic cars. By putting the technology to practice, Painless Performance is speeding up the development process. In health care, these innovative technologies are permitting American patients to do things we could never have dreamed of when I was in medical school. Health apps are allowing patients to track their symptoms, send vital sign information to doctors, and set up medication adherence reminders — all from the palm of their hand. American consumers can benefit greatly from these new and emerging technologies, if we just let them. Thanks to the members of the committee and Vice Chairman Leonard Lance of New Jersey, we have been able to elevate the very important work that the Subcommittee on Commerce, Manufacturing and Trade has been doing this Congress. As technological advances get greater and more powerful, it will be critical to keep this momentum going as we look toward the 115th Congress. Read the full column online HERE. Read More

DISRUPTER SERIES: #SubCMT to Review Self-Driving Cars NEXT WEEK

2016/11/08

WASHINGTON, DC – The Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Michael C. Burgess, M.D. (R-TX), has scheduled a hearing for Tuesday, November 15, at 10:30 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Disrupter Series: Self-Driving Cars.” The Disrupter Series continues next week with an examination of self-driving cars. Members will explore the potential impact of self-driving cars on driver and roadway safety and how this emerging technology could improve mobility, increase vehicle efficiency, and create new opportunities including economic growth and transportation access for the disabled and underserved communities. Members will also examine the Federal Automated Vehicles Policy guidance issued by the National Highway Traffic Safety Administration (NHTSA) in September. “The 21st century has spurred a new wave of innovation that is disrupting the marketplace as we know it, and the automotive industry is no exception,” said Burgess. “Next week’s hearing provides us the opportunity to review the potential impact this innovative technology will have on safety and economic growth, while allowing us to examine any regulatory roadblocks hindering its development. Driverless cars are no longer a far off idea of the future – the technology is here. Given the safety and recent rise in traffic related fatalities, it’s important we get this life-saving technology right. I look forward to hearing from industry experts next week about how we bring self-driving vehicles to consumers and businesses alike and what protections should be considered as best practices and guidelines continue to be developed.” Throughout the last year, the subcommittee’s Disrupter Series has provided an opportunity to better understand how federal policies both help and hinder growth of emerging technologies. The series has helped shaped the drafting of thoughtful, targeted legislation to ensure our policies are modernized for the 21st century and put innovation first. Next week’s hearing builds upon previous discussions of mobile health care apps, the Internet of Things, sharing economy, drones, mobile payments, 3D printing, and digital currency. The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted. Read More

#CuresIn4Words: Unlocking New Scientific Talent

2016/11/07

Beating disease requires an all hands on deck effort, and it is critical that important government stakeholders like the FDA have the capacity to attract and retain the world’s best researchers. The 21st Century Cures Act breaks down silos and other roadblocks to sharing data and treatments, so cures and treatments can be identified earlier. The nonpartisan bill will also update and modernize our health care infrastructure, giving agencies and research facilities greater resources to attract top talent. “The FDA’s hiring powers must mirror the urgency of its task. Beyond higher salaries, the FDA needs more flexibility in its recruitment and retention. That’s why Congress should pass the 21st Century Cures Act, which would unlock the agency’s potential to compete for the most qualified scientific talent,” writes Ellen Sigal, founder and chairperson of Friends of Cancer Research, and member of the White House Moonshot Blue Ribbon Panel. “The act is also essential to staffing the Oncology Center of Excellence, a key pillar of the White House’s visionary Cancer Moonshot.” [[{"fid":"1788","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"73","width":"387","class":"media-element file-full"}}]] Strengthening the FDA is critical to the fight against cancer By Ellen Sigal   Regarding the Nov. 2 PowerPost article “FDA continues to grapple with hundreds of vacancies”: For cancer patients, every day matters, and the Food and Drug Administration is a vital player in speeding lifesaving treatments to those who need them. Patients expect the FDA to hire and retain world-class talent. But for nearly a decade, the FDA has been recruiting with one arm tied behind its back. Archaic requirements and inadequate salaries make hiring exceedingly difficult, ultimately posing a threat to public safety and innovation. The FDA’s hiring powers must mirror the urgency of its task. Beyond higher salaries, the FDA needs more flexibility in its recruitment and retention. That’s why Congress should pass the 21st Century Cures Act, which would unlock the agency’s potential to compete for the most qualified scientific talent. The act is also essential to staffing the Oncology Center of Excellence, a key pillar of the White House’s visionary Cancer Moonshot. A challenge of stunning scale and complexity, curing cancer as we know it requires marshaling every available resource. That effort starts with ensuring the FDA has the staff it needs. To read the full column online, click HERE. ###   Read More

"GAME-CHANGER"

2016/11/07

Everywhere you look, support continues to build for 21st Century Cures.  Louisville's Courier-Journal: “This bill could be a true game-changer for patients.”  Utica's Observer-Dispatch: “One priority should be to enact the 21st Century Cures Act.”  IPPF: "In short, this bill could be a game-changer for patients with both rare and common diseases."  Every community around us has a connection to disease. From the rarest diseases to those that are more common, there is a unifying thread that brings hope to families and their loved ones. 21st Century Cures will accelerate the critical cycle of discovering, developing, and delivering new cures and treatments. By boosting precious research dollars and streamlining approval of these treatments, the nonpartisan bill presents an opportunity for unprecedented medical developments. From leaders in the research community to the nation’s leading cancer advocates, momentum continues to build for 21st Century Cures. From Kentucky, New York, and across the country, patient’s can’t wait another year for #CuresNow. [[{"fid":"1785","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"102","width":"515","class":"media-element file-full"}}]] Innovative medicine must be priority By Mark Dant, Louisville, KY There’s been outcry over the cost of prescription drugs, but little public discussion about the need for innovation for patients who don’t yet have an effective therapy. One in 10 Americans suffer from a rare disease, but only 5 percent of rare diseases have a treatment approved by the FDA. My son Ryan was diagnosed with MPS I when he was three, and we were told that he would not live through the decade. Now a senior at the University of Louisville, Ryan would have died many years ago had it not been for innovative science and industry investment that spawned a new drug that saved his life. The 21st Century Cures Act would provide new funding for research at the National Institutes of Health as well as funding to enhance the review of new medicines by FDA.  The legislation includes crucial incentives such as the OPEN ACT, which would encourage companies to repurpose existing medicines for rare diseases, potentially bringing hundreds of new treatments to patients more quickly than traditional drug development. This bill could be a true game changer for patients. … Click HERE to read the letter to the editor online. [[{"fid":"1786","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"89","width":"523","class":"media-element file-full"}}]] EDITORIAL: Government must get priorities straight One priority should be to enact the 21st Century Cures Act. The bill, which was approved in the House of Representatives in July 2015, would provide more funding for medical research, provide incentives for the development of rare disease treatments and expedite the federal Food and Drug Administration approval process for certain treatments. The Senate has yet to vote on similar legislation. Linda and Kirk Hinman of Lee have, in very short time, become tireless advocates for the bill. Their grandson, Spencer, was diagnosed in August with Sanfilippo syndrome (also known as MPS III), a metabolic disorder that will, short of a medical breakthrough, kill him, most likely in his teens. Spencer is 2. More research into the rare disease could possibly save him. … Yet the Senate can't get its act together on appropriating funds that could save childrens' lives? Sen. Charles Schumer, D-N.Y., says he’s on board to approve the 21st Century Cures Act. Tell him and Sen. Kirsten Gillibrand to get this done. Now. … Click HERE to read the full column online. [[{"fid":"1787","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"108","width":"407","class":"media-element file-full"}}]] Rare Disease Patients Need 21st Century Cures Now By Mark Yale, Interim Executive Director at IPPF Although there has been a huge public outcry over the cost of prescription drugs, there has been little public discussion about the need for innovation for patients who don’t yet have an effective therapy. It is estimated that 1 in 10 Americans suffer from a rare disease, and only 5% of rare diseases have a treatment approved by the Food and Drug Administration (FDA). … I was diagnosed in 2007 with cicatricial pemphigoid, a rare autoimmune blistering skin disease. Like others with a rare disease, I experienced delays in diagnosis and difficulty finding knowledgeable physicians. Eventually, I lost vision in one eye from the disease. The pain associated with my disease was severe, and the list of complications extensive. Although my disease can be treated, there are still no FDA approved treatments and no cure. No disease should be too rare for a cure. The good news is that Congress can do something to help. The 21st Century Cures Act, which passed the House of Representatives with broad bipartisan support (a rarity in the current political environment), could provide billions in new funding for research at the National Institutes of Health, the nation’s premier biomedical research institution, along with needed funding to enhance the review of new medicines by FDA. …This could potentially bring hundreds of new treatments to patients more quickly than traditional drug development. In short, this bill could be a game-changer for patients with both rare and common diseases. … Click HERE to read the full column online.   Read More

Cures Roundtable Participant: “Patients need to be Congress’ top priority as they finish their work in 2016.”

2016/11/05

Two years ago, Martin Naley had just founded Cure Forward, an organization to help patients find personalized treatments for cancer. He was a participant in one of the Energy and Commerce Committee’s early roundtable discussions on the 21st Century Cures initiative. “Congress was listening,” reflects Naley in his Medium post. “It is estimated that almost 1.7 million Americans will be diagnosed with cancer this year. These patients are the key to the success of clinical trials, drug development activity, and curative breakthroughs, and the process by which treatments and cures are made available to them can be vastly improved. The 21st Century Cures Act aims to do just that,” writes Naley. The heart of the bill seeks to advance the discovery, development, and delivery of new cures and treatments – something everyone can support. When paired with cutting-edge technology and tools, and breaking down silos to share critical research, it’s easy to see why there’s such wide-ranging support for the nonpartisan bill. “A tremendous amount of effort has been put into this bill on both sides of the aisle and it is imperative that the bill makes its way to the President’s desk this year. Patients need to be Congress’ top priority as they finish their work in 2016,” writes Naley. As some special interest groups try to delay Cures until the next Congress, Naley argues the move would cause great harm to the movement. “While the cost of drugs is a very real concern for patients, so are many of the important barriers that the Cures Act removes,” writes Naley. “Both need to be addressed, but let’s not slow innovation and hinder medical research in the interim. Take a look at the 700+ groups that have endorsed the Cures Act. It’s a who’s-who of patient advocacy organizations and professional associations — household names that everyone can trust.” Now is the time for Cures. Patients have been waiting long enough. [[{"fid":"1784","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"85","width":"342","class":"media-element file-full"}}]] Congress Got This One Right. Now is the Time to Finish It. By Martin Naley, Cure Forward It was July 2014. I had just founded Cure Forward. I hadn’t even hired our first employee yet. And then, out of the blue, I received an invitation to participate in a roundtable held by the Energy & Commerce Committee of the US House of Representatives. The topic: “21st Century Cures — Leveraging Technology to Advance the Discovery, Development, and Delivery of Better Treatments and Cures”. It was such an honor to be included. The dozen or so panelists that day included nationally known scientists, the president of the Personalized Medicine Coalition, a top official from the FDA, leaders from top academic medical centers, and presidents of patient advocacy nonprofit organizations. Just being in their presence was a big deal, never mind the chance to have a voice on such an important topic. The roundtable was one of several held that summer. Congress was listening. A bipartisan coalition, led by representatives Fred Upton (R -Michigan) and Dianna DeGette (D- Colorado), came with sincere interest and thoughtful questions. One of the representatives asked about access, and I jumped in to answer. I was nervous, but I managed to convey three points of access that would need to be addressed for precision medicine to work: (1) access to molecular profiling testing, to determine opportunities for treatment including clinical trials; (2) access to one’s data and tools to use it, so a person could understand their disease and partner with their physician in identifying treatment options; and (3) access to molecularly targeted treatments, sometimes in cases where their indication didn’t match approved uses, through a learning network. I described how the federal government could affect all three of these things, and how legislation could help. I was excited to be heard. The 21st Century Cures roundtables continued for several months, in Washington and across the country in various Representatives’ districts. Through all that listening, themes were identified, and eventually legislation came together. The 21st Century Cures Act passed in the US House of Representatives in July 2015. I am proud to have had even a small role in it. It is estimated that almost 1.7 million Americans will be diagnosed with cancer this year. These patients are the key to the success of clinical trials, drug development activity, and curative breakthroughs, and the process by which treatments and cures are made available to them can be vastly improved. The 21st Century Cures Act aims to do just that. The Cures Act would further incorporate patient participation at all stages of discovery, development, and delivery. It would enhance the ability of patients to search for and find clinical trials, and use those patients’ experiences once enrolled in a trial to help regulators make decisions about a treatment or cure. Patient-reported outcomes will become tools that can help forge pathways to improve medical options for those living with an illness. Moreover, the bill would make it easier for certain patients to receive new therapies by requiring manufacturers to make their policies on responding to compassionate use requests publicly available. The bill doesn’t stop there. The Cures Act also aims to remove barriers to innovation so that treatments can more quickly get into the hands of patients. The bill would streamline and modernize clinical trials and improve our ability to focus on cutting-edge, novel research. It would give manufacturers and FDA better tools based on sound science for accessing the ability of a therapy to improve the lives of patients. The bill also emphasizes the importance of breaking down silos and sharing research data to ensure that all hands are on deck when tackling our greatest research challenges, and makes a point to require that FDA keeps pace with the newly emerging field of precision medicine. Every bit of research helps. However, cooperative efforts like the Cancer Moonshot Initiative are vital for providing a blueprint for how to accelerate and extend progress for the cancer patients. I hope that the final version of the bill provides the National Institutes of Health with the means to ensure the success of the Cancer Moonshot program. A tremendous amount of effort has been put into this bill on both sides of the aisle and it is imperative that the bill makes its way to the President’s desk this year. Patients need to be Congress’ top priority as they finish their work in 2016. But that’s not the end of the story. Once The Cures Act passed the US House, the Senate took up its own efforts to develop health care innovation legislation. Again, there was bipartisan support to get this important work done. And now, here we are, a few months from the end of the current session of Congress. The bill has taken some time, mainly because some of the measures require funding in a very tight budget. However, policymakers must also come to an agreement about what to include during a very contentious election year measures. However, if the Senate passes a bill, then the House and Senate versions can be reconciled through committee, and a final vote can ratify the legislation, making it law. We need this to happen. If not, the process does not just continue next year with new people in Congress. Instead, the House and Senate would need to begin anew. That would be a huge loss for patients and for the people who want to help them. Recently, several consumer organizations sent a letter to Congress opposing moving the Cures Act without also addressing the complicated issue of drug pricing. While the cost of drugs is a very real concern for patients, so are many of the important barriers that the Cures Act removes. Both need to be addressed, but let’s not slow innovation and hinder medical research in the interim. Take a look at the 700+ groups that have endorsed the Cures Act. It’s a who’s-who of patient advocacy organizations and professional associations — household names that everyone can trust. When you know what the Cures Act really is all about, it becomes clear that everyone should support this legislation, which is really about helping more patients have access to better treatments sooner. I felt fortunate to have a voice that day in 2014. It turns out we all have a voice, and it’s our obligation to speak up for what matters most. Last month, House Speaker Paul Ryan and Senate Majority Leader Mitch McConnell said the medical innovation package would be a top priority for the lame duck session, and the ranking Democrats on the House Energy and Commerce and Senate HELP Committees agreed their goal was to pass a bill this year. Let’s help to get this done. Use your voice on social media. The hashtags are: #CuresIn4Words, #CuresNow, #Path2Cures … This matters to us all. Let’s make sure we’re heard. To read the full column online, click HERE. ### Read More

Passionate Pint-Sized Cures Advocate Takes Over House GOP Blog

2016/11/04

[[{"fid":"1782","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"267","width":"401","class":"media-element file-full"}}]] Remember Max? He’s the all-star patient advocate who has be energizing folks on the #Path2Cures for the last couple of years. Today, 7-year-old Max was the latest guest blogger for the House Republican Conference. Max has a RASopathy called Noonan syndrome, which prevents normal development in various parts of the body. In Max’s blog post, he explains the disease and his strong support for the 21st Century Cures Act. “21st Century Cures is legislation to help all those that are sick, not just those with rare diseases,” explains Max. “For me it means less surgeries and maybe not having to get a shot every night and maybe being able to just take a pill instead. It will help everyone because we will all be sick someday.” It’s a straightforward concept that will impact every American family. We need #CuresNow. [[{"fid":"1783","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"107","width":"182","class":"media-element file-full"}}]] Please Help Me Pass #CuresNOW By Max Schill My name is Max and I am seven years old, soon to be eight. My fight for 21st Century Cures started when I was five. But I guess it started sooner than that, on the day I was born with a rare disease – a RASopathy called Noonan Syndrome. Noonan Syndrome is a genetic syndrome that affects cell growth and cell development. For me it means I have to visit a lot of doctors and have a lot of tests and procedures. Rare is not as rare as you think. There are over 7,000 rare diseases in the world. 95% of them don’t have treatments. Treatments can take over 15-20 years to develop and cost billions of dollars! I don’t have that kind of money in my big blue piggy bank. I only have about one hundred dollars. I don’t think that will get 21st Century Cures very far. That is why I am asking for the government’s help to pass 21st Century Cures. 21st Century Cures is legislation to help all those that are sick, not just those with rare diseases. For me it means less surgeries and maybe not having to get a shot every night and maybe being able to just take a pill instead. It will help everyone because we will all be sick someday. We need to smack down and take down the horrible diseases. Doctors will find a way to fix them with the government’s help.  We all deserve treatments and cures. This is why I have helped advocate for 21st Century Cures from the beginning. I have drawn pictures in support of 21st Century Cures. I have met with Members of the House of Representatives and attended the Committee vote (which passed unanimously – everyone said AYE!) and the House Vote (which passed 344-77). Those were really big wins! I have made over 100 support #CuresNOW pictures for each Senate office and hand delivered them to over 80 offices.  (My legs got too sleepy to hand deliver them all.) I have helped make videos to help encourage and motivate the Senate to help pass 21st Century Cures.  Even with all of this work and the work of many others, 21st Century Cures is still not a law. This is why I need your help. My birthday is December 12th. My birthday wish is that 21st Century Cures will pass and become a law.  Please help pass #CuresNOW by supporting the bill. Draw pictures yourself and talk to everyone you know about it. Vote YES for 21st Century Cures! The 21st Century Cures bill will help a lot of people and save a lot of kids in the hospital.  Please help develop new treatments and cures! Time is running out. Please, before it is too late. Love your friend, Max Note: One of 21st Century Cures’ most vocal advocates, Max heard that his mom was writing a blog post about the cause and told her that he wanted to write something, too. The above piece is his first person account, with the help of his proud mom. Read the column online HERE. ###   Read More

50 of Nation’s Leading Cancer Groups: Patients Can’t Wait Another Year for Vote On #CuresNow

2016/11/04

WASHINGTON, DC – The nonpartisan support for the 21st Century Cures Act continues to grow stronger by the day. Last week, leading research groups wrote to bipartisan Congressional leadership urging a swift vote on the Cures legislation when Congress returns. That support continues with a letter from One Voice Against Cancer (OVAC), signed by 50 of the nation’s leading cancer-related organizations. Together, they have been engaged on the effort to deliver #CuresNow, and finding an avenue to act on Vice President Biden’s cancer moonshot initiative. Just as the committee has articulated, OVAC believes the 21st Century Cures Act serves as a critical vehicle to deliver funding for the moonshot initiative. “OVAC members believe the Cancer Moonshot Initiative objective of making a decade’s worth of life saving scientific progress in the next five years can most likely be achieved by Congress promptly assuring essential funding of it by enactment of the 21st Century Cures Act in 2016,” wrote the groups within OVAC. “…The importance of Congress funding the Cancer Moonshot Initiative as soon as possible by enactment of the 21st Century Cures Act in 2016 is without question. Waiting until next year to act is not an option for cancer patients and their families.” Patients and families can’t wait. It’s time for #CuresNow. The 50 groups that signed the letter are: Action to Cure Kidney Cancer Alliance for Prostate Cancer Prevention (APCaP) American Academy of Dermatology Association American Association for Cancer Research American Cancer Society Cancer Action Network American College of Surgeons Commission on Cancer American Sexual Health Association American Society of Clinical Oncology American Society for Radiation Oncology (ASTRO) American Urological Association Asian & Pacific Islander American Health Forum Association of American Cancer Institutes Bladder Cancer Advocacy Network Cancer Support Community Charlene Miers Foundation for Cancer Research Debbie’s Dream Foundation: Curing Stomach Cancer Dermatology Nurses’ Association Esophageal Cancer Action Network Fight Colorectal Cancer Friends of Cancer Research Hematology/Oncology Pharmacy Association (HOPA) Intercultural Cancer Council Caucus International Myeloma Foundation LIVESTRONG Foundation Leukemia & Lymphoma Society (LLS) The Life Raft Group Lung Cancer Alliance Malecare Cancer Support Men’s Health Network Mesothelioma Applied Research Foundation MPN Research Foundation National Alliance of State Prostate Cancer Coalitions (NASPCC) National Association of Chronic Disease Directors National Brain Tumor Society National Cervical Cancer Coalition National Coalition for Cancer Research (NCCR) National LGBT Cancer Project National Patient Advocate Foundation Oncology Nursing Society Ovarian Cancer Research Fund Alliance Pancreatic Cancer Action Network Pennsylvania Prostate Cancer Coalition (PPCC) Prevent Cancer Foundation Prostate Conditions Education Council Sarcoma Foundation of America Society of Gynecologic Oncology St. Baldrick’s Foundation Susan G. Komen Us TOO International Prostate Cancer Education and Support Network ZERO – The End of Prostate Cancer ### Read More

2016 a Year Of Life-Changing Milestones

2016/11/03

[[{"fid":"1780","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"237","width":"338","class":"media-element file-full"}}]] It’s no secret that Energy and Commerce Committee Chairman Fred Upton (R-MI) is a proud, lifelong Chicago Cubs fanatic. He is an optimist through and through. And for the Cubs, “this was the year.” After 108 years, “it happened.” Chairman Upton is equally passionate, and optimistic, when it comes to 21st Century Cures. Flashing back to a Politico Pro report from July: Upton, a loyal Chicago Cubs fan, cited same optimism for Cures as he has for a baseball team that hasn’t won a World Series in over a century. “As they say at Wrigley, it’s going to happen,” he said. “This is the year.” 2016 is the year for the Cubs. And it is the year for 21st Century Cures. Today, homes across the country are proudly (and exuberantly) “flying the W.” Chairman Upton knows it won’t be the only opportunity to do so the rest of the year. [[{"fid":"1781","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"334","width":"351","class":"media-element file-full"}}]] “2016 is ‘the year’ in so many ways, and lives are changing for the better,” said Chairman Upton. “Patients and advocates have been going to bat for this nonpartisan effort for years, and there’s no stopping us now. This is truly a once-in-a-generation opportunity to change the way we view and treat disease. For every family touched by illness, we will get this done. It’s going to happen.” Folks are singing “Go, Cubs, Go,” but we’re also chanting “#CuresNow” louder than ever. As Chairman Upton has said, “Watch the magic” when Congress returns. This is the year for #CuresNow. We can't wait until next year. ### Read More

VIDEO: A Trip Down the #Path2Cures

2016/11/02

[[{"fid":"1779","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":"","field_file_image_title_text[und][0][value]":""},"type":"media","link_text":null,"attributes":{"height":"261","width":"468","class":"media-element file-full"}}]] Click HERE to watch Upton’s message. ### Read More

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