WASHINGTON, DC – The House Energy and Commerce Committee today announced its hearing and vote schedule for the week of July 14. The committee will investigate the anthrax lab incident and the CDC’s adherence to safety protocol measures. The committee will also vote on a series of bipartisan public health and job creating bills and examine innovative technology for 21st Century Cures.
On Monday, July 14, the Energy and Commerce Committee will convene for opening statements in preparation for a vote on the following bills:
The committee will reconvene on Tuesday, July 15, to vote on the legislation. Electronic copies of the bills and a background memo can be found on the Energy and Commerce Committee’s website here. Amendments and votes will be available at the same link as they are posted.
On Wednesday, July 16, the Subcommittee on Oversight and Investigations will examine the anthrax lab incident at the Centers for Disease Control and Prevention (CDC). As part of the ongoing investigation into the potential live anthrax exposure of more than 80 workers at a CDC lab in Atlanta, committee leaders earlier this week sent letters to the CDC and HHS Inspector General seeking documents and information. Dr. Tom Frieden, Director of the CDC, will be among the witnesses testifying. The Majority Memorandum, witness list, and witness testimony will be available here.
Also on Wednesday, the Subcommittee on Health will review the reports HHS OIG recently released regarding the “inconsistencies” in Obamacare applications within the federally facilitated marketplace. The reports found that through February 2014, there were 2.9 million inconsistencies, 2.6 million of which had yet to be addressed. The Majority Memorandum, witness list, and witness testimony will be available here.
On Thursday, the Subcommittees on Communications and Technology and Health will hold a joint hearing to explore how advances in communications and technology can transform 21st Century Cures. “Learning how we can update our laws to foster new technologies and harness the power of these innovations to accelerate and strengthen the discovery, development, and delivery cycle of new cures and treatments is exactly what our #CommActUpdate and 21st Century Cures initiatives are all about,” said Chairman Upton. Members will hear from experts in both the health and technology fields regarding areas where the health care industry can take advantage of advances in technology to accelerate the #Path2Cures. The Majority Memorandum, witness list, and witness testimony will be available here.
Hearing and Vote Details:
Monday, July 14, 2014
4 PM2123 Rayburn HOBFull Committee Markup of H.R. 4771, H.R. 4250, H.R. 594, H.R. 669, H.R. 4290, H.R. 4450, H.R. 5057 (opening statements only)
Tuesday, July 15, 2014
10 AM2123 Rayburn HOBReconvene Full Committee Markup of H.R. 4771, H.R. 4250, H.R. 594, H.R. 669, H.R. 4290, H.R. 4450, H.R. 5057
Wednesday, July 16, 2014
10 AM2123 Rayburn HOBSubcommittee on Oversight and InvestigationsHearing on “Review of CDC Anthrax Lab Incident”
10:15 AM2322 Rayburn HOBSubcommittee on HealthHearing on “Failure to Verify: Concerns Regarding PPACA’s Eligibility System”
Thursday, July 17, 2014
9:30 AM2123 Rayburn HOBSubcommittees on Communications and Technology and HealthHearing on “21st Century Technology for 21st Century Cures”
WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) will address the U.S. Energy Information Administration 2014 Energy Conference on Tuesday afternoon to share his vision for America’s energy policy – the Architecture of Abundance. Chairman Upton will outline the policies needed to construct this new architecture that will allow us to harness the benefits of America’s growing energy resources.
Who: House Energy and Commerce Committee Chairman Fred Upton
What: 2014 EIA Energy Conference
When: Tuesday, July 15, 2014, 12:15 p.m.
Where: JW Marriott, 1331 Pennsylvania Ave NW, Washington, DC 20004
For more information about the event and to register, visit: http://www.fbcinc.com/e/EIA
WASHINGTON, DC – The Energy and Commerce Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing in the 21st Century Cures initiative to incorporate the patient perspective in the #Path2Cures process. Witnesses shared their suggestions and recommendations to bring more cures and treatments to patients more quickly. As Chairman Pitts explained, “Keeping our work centered on the patient and understanding the patient perspective will bring much needed focus on results for patients who may lack adequate treatment options.”
Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, explained, “In recent years, there have been important advances to help ensure that therapies for serious conditions are approved and available to patients as soon as there are sufficient data to show that the therapies’ benefits outweigh their risks. Despite this progress, there is much more work to be done. Many scientific discoveries still need to be translated into treatments for patients in need of new lifesaving therapies. FDA is committed to doing our part to help bridge this gap.”
Dr. Leonard Lichtenfeld with American Cancer Society testified, “Every disease is unique in terms of the unmet need for therapies and the risks that patients are willing to accept in the quest for new treatments. If researchers, pharmaceutical companies and the FDA engage widely and meaningfully with patients, the result will be better treatments delivered to patients faster.”
“I would encourage greater flexibility in clinical trials, particularly for fatal rare diseases like Duchenne that have smaller populations. Business-as-usual trial design simply will not hit the mark when working with such populations,” testified Founding President and CEO of the Parent Project Muscular Dystrophy, Pat Furlong. “We need treatments and therapies, right now, so we can end Duchenne and address the thousands of other rare diseases in need of treatments and cures.”
Dr. Robert Beall with the Cystic Fibrosis Foundation said, “As policy options are considered, it is important to find a balance between accelerating drug discovery and innovation, while also ensuring that patients have safe, effective treatments. … (T)here must be clear communication about the benefits of current therapies so that patients can make informed decisions… as new therapies are developed.”
Members and stakeholders are committed to working together and continuing efforts on the Cures initiative. Dr. Marshall Summar with the National Organization for Rare Disorders emphasized the importance of these efforts, stating, “We view the 21st Century Cures Initiative as a great opportunity to move the process of therapeutic development and approval forward. This is particularly important for Rare Diseases where need is often acute and classic approval models can delay life-saving treatment.”
Alkermes CEO Richard Pops summed up the importance of patient perspectives, testifying, “The simple and powerful concept of incorporating insights of patients, individually and collectively, throughout the continuum that begins with the discovery of new drugs and extends all the way to ensuring patients have access to them – is centrally important to the future of the life sciences industry – and one of the great opportunities for us to have a transformative impact on our nation’s healthcare system.”
WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) responded to the latest announcement by the Centers for Disease Control and Prevention (CDC) on additional safety breaches. As part of the ongoing investigation into the potential exposure of more than 80 workers at a CDC lab in Atlanta to live anthrax, committee leaders earlier this week sent letters to the CDC and HHS Inspector General seeking documents and information. CDC Director Dr. Tom Frieden is scheduled to testify before the Oversight and Investigations Subcommittee next Wednesday, July 16, at 10 a.m.
Chairman Upton commented, “The repeated breakdown in protocols and safety failures involving the world’s deadliest germs and pathogens is wholly unacceptable. The consequences of such carelessness could not be more dire. This latest revelation underscores the need for our investigation and the importance of next week's hearing to review the safety measures and practices at the CDC. Past fixes by CDC several years ago apparently were not followed and not adequately implemented. We will seek to find out why CDC thinks its latest actions will prove more effective than past efforts, and whether congressional intervention may be necessary. We look forward to hearing directly from Dr. Frieden next Wednesday and will seek his firm commitment that such safety lapses are over.”
Subcommittee Chairman Murphy added, “With the release of today’s report, we’ve learned the dangerous transfer of possible live anthrax bacteria by the CDC’s Atlanta lab was not an isolated incident by a rogue scientist, but rather one of multiple mishaps over the last several years that were violations, or apparent violations, of federal regulations for handling deadly biological material. These repeated safety failures raise grave concerns about the CDC’s ability to ensure strict procedures, protocols, and training are followed and an area we will examine further at Wednesday’s Oversight and Investigations Subcommittee hearing.”
WASHINGTON, DC – House Communications and Technology Subcommittee Chairman Greg Walden (R-OR) and Vice Chairman Bob Latta (R-OH) expressed dismay with the latest evidence of opaque decision-making at the Federal Communications Commission, including reports that final items were not distributed to FCC Commissioners for today’s open meeting until just before the vote.
“The chairman did not need to do it this way. Deliberations at the FCC need to include all commissioners. Period.” said Walden. “When commissioners don’t receive drafts of proposals until shortly before the vote, there has been a colossal breakdown of process, collegiality, and trust that should characterize the work of the commission. If Chairman Wheeler’s intent is to keep his fellow commissioners in the dark and uninformed – then job well done. But for the sake of sound policymaking, public confidence and good process, commissioners should have ample time and ability to thoughtfully consider items before voting on them.”
“Today’s item on improving the Universal Service Fund schools and libraries program could have been a bipartisan success story – bringing 21st century educational tools to the students that need them to thrive,” said Latta. “Unfortunately, Chairman Wheeler’s ‘my way or the highway’ approach to working with his fellow commissioners has resulted in a partisan outcome that will ultimately place new costs on American consumers. The American people deserve better.”
WASHINGTON, DC – The Subcommittee on Environment and the Economy, chaired by Rep. John Shimkus (R-IL), today held a hearing on “Constitutional Considerations: States vs. Federal Environmental Policy Implementation.” The hearing focused on the authority the Constitution grants Congress to set uniform, national standards in certain aspects of environmental policy and the role of the states in taking the lead in crafting state-specific environment solutions.
Environmental federalism is a longstanding topic of interest to the subcommittee. The subcommittee’s first hearing this Congress featured representatives from state offices and their views on the role states play in protecting the environment. At today’s hearing, members heard from a panel of Constitutional law experts about the scope of Congress’ authority under the Commerce Clause, limitations on Congress’ power set by the Tenth Amendment, and other factors Congress should consider when evaluating policy implementation.
“Today’s hearing gives us an opportunity to discuss some important questions we face as lawmakers. When we create policies to protect human health and the environment, when should we defer to states? When should policy be set at the national level but implemented at the state level? When should it be implemented at the national level? At first, different provisions of the U.S. Constitution seems to offer different answers. But our job is to reconcile those provisions,” said Chairman Shimkus.
Jonathan Adler, Professor of Law at Case Western University, explained the importance of constitutional limitations on federal environmental polices, stating, “It is a fundamental principle of our constitutional order that the federal government is one of limited and enumerated powers, and that those powers not delegated to the federal government are reserved to the states and the people. All federal laws, no matter their value or purpose, must be enacted pursuant to the federal government’s enumerated powers and may not transgress other constitutional constraints. This is as true for environmental protection as it is for national security or health care.”
Adler went on to assert that the federal government should only intervene when necessary and beneficial, such as a need to eliminate burdens on interstate commerce. Adler stated, “Despite the environmental successes of the past three decades, the overlapping and contradictory state and federal rules do not lead to efficient or effective environmental protection. It is in some senses an historical accident that state leadership in environmental policy was supplanted by federal regulation, and environmental policy could be improved if states regained more of their historic role. The federal government did not come to dominate environmental policy because a more decentralized system was leading to environmental ruin, and much of the what the federal government does in environmental policy could be left to the states.”
Richard Revesz, Professor of Law and Dean Emeritus at New York University School of Law, described situations when, if ever, the federal government should preempt state standards. He explained, “In general, the federal government should act when a pathology, such as the presence of interstate externalities, would lead some states to set suboptimally lax standards if left to their own devices. But those standards should be viewed as minimum standards, allowing states to set more stringent limits if they wish to do so.” However, Revesz clarified exceptions should exist in cases such as “goods exhibiting significant economies of scale in production,” explaining, “In such cases, disparate state regulation would break up the national market for the product and be costly in terms of foregone economies of scale.”
Chairman Shimkus pledged to continue to examine this important topic and said, “At our next hearing on July 23 we invite EPA, the states, and others to discuss steps to modernize state and federal cooperation.”
The Subcommittees on Communications and Technology and Health, chaired by Rep. Greg Walden (R-OR) and Rep Joe Pitts (R-PA), respectively, have scheduled a joint hearing for Thursday, July 17, 2014, at 9:30 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled “21st Century Technology for 21st Century Cures.” Witnesses to be announced.
“Remarkable advancements in technology are transforming health care as we know it. Companies embracing telemedicine and mHealth solutions can bring patients, researchers, and doctors together in ways we never could have imagined just a decade ago. Learning how we can update our laws to foster new technologies and harness the power of these innovations to accelerate and strengthen the discovery, development, and delivery cycle of new cures and treatments is exactly what our #CommActUpdate and 21st Century Cures initiatives are all about,” said full committee Chairman Fred Upton (R-MI). “The collaboration of the Health and Communications and Technology Subcommittees allows for an exciting conversation about what’s next and how we can best leverage our nation’s technological leadership to improve our health care system.”
As Chairman Upton wrote in U.S. News and World Report in March, “Patients, doctors and scientists are now linked like never before. Today, these three disciplines – medicine, computers and social networks – have an unprecedented opportunity to collaborate as friends in a new way to help all of us to live longer, healthier lives.” Members will hear from experts in both the health and technology fields regarding areas where the health care industry can take advantage of advances in technology to accelerate the #Path2Cures.
Committee members recently held a 21st Century Cures roundtable to discuss how digital health care can improve the cycle of cures. The Health Subcommittee has also recently explored how telehealth and digital medicine can improve the quality and accessibility of care for patients.
The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted.
The Energy and Commerce Committee has scheduled a markup next week to consider seven bills to improve the public health, provide regulatory relief, and boost the economy. The committee will convene for opening statements only on Monday, July 14, 2014, at 4:00 p.m. in room 2123 of the Rayburn House Office Building. The committee will reconvene in the same room on Tuesday, July 15, at 10:00 a.m. to consider the legislation. Full Committee Chairman Fred Upton (R-MI) recently released a midyear report chronicling the committee’s accomplishments in the first half of 2014. The committee looks to build on that success as it considers the following legislation:
H.R. 594, the Paul D. Wellstone Muscular Dystrophy Community Assistance, Research, and Education Amendments, authored by Rep. Michael C. Burgess, M.D. (R-TX) and Rep. Eliot Engel (D-NY). H.R. 594 would update surveillance, research, and education activities to reflect scientific developments and continue the support of research and patient support initiatives across all forms of Muscular Dystrophy.
H.R. 669, the Sudden Unexpected Death Data Enhancement and Awareness Act, introduced by Rep. Frank Pallone (D-NJ) and Rep. Peter King (R-NY). This bill provides for activities to help improve the understanding of stillbirth, sudden unexpected infant death, and sudden unexplained death in children.
H.R. 4290, the Wakefield Act, introduced by Rep. Jim Matheson (D-UT) and Rep. Peter King (R-NY). The Wakefield Act would reauthorize grant programs that support the expansion, improvement, and evaluation of emergency medical services for children.
H.R. 4771, the Designer Anabolic Steroid Control Act, introduced by Rep. Joe Pitts (R-PA) and Rep. Frank Pallone (D-NJ). This bill would classify certain anabolic steroids, substances often found in bodybuilding products and marketed as dietary supplements, as controlled substances. Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced a version of this bill in the Senate in February 2014.
H.R. 4250, the Sunscreen Innovation Act, introduced by Rep. Ed Whitfield (R-KY) and Rep. John Dingell (D-MI). This bill would streamline the FDA’s approval process for new sunscreen ingredients while maintaining strict safety standards. The FDA has not approved a new sunscreen ingredient in nearly two decades. This legislation would require that pending and new applications be completed in a more predictable and transparent manner. Senators Johnny Isakson (R-GA) and Jack Reed (D-RI) have introduced similar legislation in the Senate, S. 2141.
H.R. 4450, the Travel Promotion, Enhancement, and Modernization Act of 2014, authored by Rep. Gus Bilirakis (R-FL) and Rep. Peter Welch (D-VT). This bill would reauthorize funding for Brand USA and increase accountability and transparency of the program. The bill would allow Brand USA to continue to promote U.S. tourism and economic growth without any cost to U.S. taxpayers.
H.R. 5057, the EPS Service Parts Act of 2014, introduced by Rep. Cory Gardner (R-CO) and Rep. Paul Tonko (D-NY). This legislation exempts certain external power supply (EPS) service and spare parts from DOE efficiency standards. DOE maintains the authority to include limited reporting requirements and modifications to prevent potential misuse of the exemption.
Electronic copies of the bills can be found on the Energy and Commerce Committee’s website here. A background memo, amendments, and votes will be available at the same link as they are posted.
WASHINGTON, DC – The Subcommittee on Commerce, Manufacturing, and Trade, chaired by Rep. Lee Terry (R-NE), today approved a series of bills to protect small businesses and boost economic growth.
The subcommittee approved a draft of the Targeting Rogue and Opaque Letters Act, or TROL Act, by a bipartisan vote of 13 to 6. The draft bill offers a balanced solution to address abusive patent demand letters and is the product of months of bipartisan negotiations amongst members and stakeholders. The legislation aims to protect businesses from abusive patent “trolls” while preserving the ability of patent holders to legitimately protect their intellectual property. The bill increases transparency and accountability in patent demand letters and provides the Federal Trade Commission (FTC) with the authority to levy fines on fraudulent practices. Ahead of the vote, a broad group of stakeholders urged support for the commonsense legislation. To view a list of supporters, click HERE.
Chairman Terry said, “With so many stakeholders with differing perspectives, the process has been difficult—but our product reflects the input of the most divergent interests on this subject. Our bill strikes the appropriate balance.”
The subcommittee approved H.R. 4013, the Low-Volume Motor Vehicle Manufacturers Act, by a bipartisan vote of 15 to 6. The legislation reduces regulatory burdens on small businesses that manufacture a small number of specialty cars, including replica cars used in exhibitions and parades. The bill exempts manufacturers of these specialty vehicles from certain standards. With an amendment by full Committee Chairman Fred Upton (R-MI), the legislation would provide this regulatory relief to manufacturers for the production of no more than 500 such vehicles per year.
The Subcommittee unanimously approved H.R. 4450, the Travel Promotion, Enhancement, and Modernization Act of 2014, by a vote of 22 to 0. The legislation, authored by Reps. Gus Bilirakis (R-FL) and Peter Welch (D-VT), would reauthorize funding for Brand USA while increasing accountability and transparency of the program. The bill would allow Brand USA to continue to promote U.S. tourism and economic growth without any cost to U.S. taxpayers. The bill has strong support from a wide range of stakeholders. To view a list of supporters, click HERE.
Bilirakis said, “The United States is a global hub for commerce and travel, and an exceptional attraction for international tourists. Tourism is the lifeblood of our economy. Increased tourism means more American jobs. I am proud that my colleagues have joined me in a bipartisan effort to pass H.R. 4450 through the Subcommittee. The Travel Promotion, Enhancement, and Modernization Act will increase Brand USA’s efficiency, effectiveness, and transparency. My legislation means promoting economic growth while not utilizing a dime of taxpayer dollars. It is time to get Americans across the country back to work.”
WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Communications and Technology Subcommittee Chairman Greg Walden (R-OR) today wrote to Federal Communications Commission Chairman Tom Wheeler ahead of the commission’s Friday vote on reforms to the Universal Service Fund’s Schools and Libraries Program. The leaders expressed concern at reports that Chairman Wheeler has amended his June proposal to now grow the size of the USF above its current $9 billion funding level on the back of rate-payers.
“As we wrote you earlier this year, the explosive and unconstrained growth of the Universal Service Fund is extremely troubling to us, and it is more important than ever that USF programs be structured to maximize value without growing the size of the fund. Last month, you announced a proposal to reform the E-Rate through streamlining administration of the fund and improving utilization of existing funds; this is an approach we support,” wrote Upton and Walden. “Unfortunately, recent reports raise concerns about your commitment to work within existing funds.”
The leaders continued, “We are also troubled by press reports that you have promised to increase the E-Rate budget in the ‘near term’ and recent allegations by Commissioner Pai that you are planning to grow the size of the existing $9 billion Universal Service Fund through commission action in a subsequent item. This would be an unacceptable course of action. We urge you to modernize the fund to bring our nation’s students the twenty-first century tools they need to succeed without increasing the ever-growing burden of USF on rate-payers.”
Highlighting this item as yet another example of bad process, the leaders concluded, “In addition to the financial considerations, recent reports have also raised red flags as to the procedural approach to this item. As you know, good FCC process has long been a priority for the committee. Engaging in bipartisan deliberation of all items should be the goal for every chairman, particularly when all parties should share the same goals: creating a fund that will appropriately serve schools and the students that rely on modern technology, and that is fiscally prudent and does not over-burden ratepayers.”
To read the complete letter online, click here.
2125 Rayburn HOB
Washington, DC 20515