SALT LAKE CITY – Rep. Chris Stewart will host his annual conference, “America’s Role in the World” on Friday, July 29, 2016 at the University of Utah.
Washington, D.C. – Today, Rep. Chris Stewart (R-Utah) lead a bi-partisan group of 61 Members of Congress urging the Federal Drug Administration (FDA) to allow smaller traditional compounding pharmacies to continue compounding prescription drugs for healthcare providers to use in their offices.
Drug compounding is used to prepare personalized prescriptions for patients or for physicians to use for procedures in their offices. Compounding pharmacists can combine certain ingredients or medications in the exact strength and dosage to customize a prescription to meet specific needs.
Ignoring a specific Congressional directive, the FDA issued Draft Guidance on April 15, 2016, that prohibits office-use compounding by smaller traditional compounding pharmacies, known as 503A compounding pharmacies.
“The Congress has been very clear with the FDA in its intent behind the Drug Quality and Security Act (DQSA),” the letter states. “Unfortunately, the FDA has to date ignored that congressional intent and substituted the agency’s own, incorrect interpretation of the law in implementing and enforcing the DQSA. We write to reiterate the directive contained in this year’s appropriations report for the FDA and now in the House committee-passed FY17 report to issue a final guidance document on how office-use compounding can be done in a manner consistent with 503A and which protects both patient safety and patient access to critical medications.”
The letter is signed by 61 Members of the House of Representatives including:
Representatives Chris Stewart, Judge Carter, Buddy Carter, Morgan Griffith, Henry Cuellar, David Young, Rob Bishop, Dave Brat, Joe Heck, Mia Love, John Culberson, Marsha Blackburn, Pete Olson, Reid Ribble, Pete Sessions, Collin Peterson,Michael Burgess, Billy Long, Cathy McMorris Rogers, David Roe, Gus Bilirakis, Barbara Comstock, Jason Chaffetz, Cresent Hardy, Lou Barletta, Randy Forbes, Kevin Cramer, French Hill, Tom Price, Lynn Jenkins, Don Young, Bruce Westerman, Doug Collins, Ryan Zinke, Jaime Herrera Beutler, Kurt Schrader, Robert Pittenger, Scott Garrett, James Sensenbrenner, Kenny Marchant, Frank LoBiondo, Leonard Lance, Matt Salmon, Martha McSally, Tom McClintock, Mac Thornberry, Richard Nugent, Mark Pocan, Charles Boustany, Steve Womack, Dave Trott, Paul Gosar, Bob Goodlatte, Rodney Frelinghuysen, Tom Reed, Rod Blum, Tom Marino, Rick Crawford, Barry Loudermilk, Austin Scott and Bill Flores
The Full text of the letter is below. For a PDF copy, click here.
Dear Commissioner Califf,
As the Congress considers appropriations for the Food and Drug Administration (FDA) for Fiscal Year 2017, we write to express our concern that the FDA has ignored a clear directive in the House Report accompanying the FY2016 FDA appropriations legislation (House Report 114-205). That report language directed the FDA, within 90 days of enactment, to issue a guidance document on how state-licensed compounding pharmacies can provide healthcare providers with compounded medications for administration to their patients in an office setting (commonly referred to as “office-use”) consistent with Section 503A of the Food, Drug and Cosmetic Act (FDCA). Instead of complying with this congressional directive, on April 15, 2016, the agency issued a Draft Guidance entitled “Prescription Requirement under Section 503A of the Food, Drug and Cosmetic Act” that expressly prohibits office-use compounding by 503A compounding pharmacies.
It is unacceptable that the FDA would ignore the Congress and continue to take the position that Section 503A specifically prohibits office-use compounding, despite clear congressional intent to the contrary and despite previous FDA actions that directly contradict that position, including the recent statement by Health and Human Services Secretary Burwell that also directly conflicts with FDA’s current position on “office-use”. For these reasons, the House Appropriations Committee on April 19, 2016, included report language in the FY17 FDA Appropriations legislation that passed out of the full committee acknowledging the Draft Guidance referenced above and directing that the Final Guidance document issued by the FDA allow for office-use compounding by 503A pharmacies.
Prior to the passage of the Drug Quality and Security Act (DQSA) of 2013, FDA circulated a draft Compliance Policy Guide (CPG) in 2012 to Congress that recognized office-use as legitimate and permissible and explained how compounding pharmacists can engage in office-use compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A of the FDCA. The DQSA did not change the statutory language in 503A that was the basis of that CPG. During the consideration of the DQSA, six Members of Congress, on a bipartisan, bicameral basis, made statements in the Congressional record to clarify that the intent of the legislation was to preserve patient access to medications compounded for office-use.
The Congress has been very clear with the FDA in its intent behind the DQSA as it relates to office-use compounding by 503A pharmacies. Unfortunately, the FDA has to date ignored that congressional intent and substituted the agency’s own, incorrect interpretation of the law in implementing and enforcing the DQSA. We write to reiterate the directive contained in this year’s appropriations report for the FDA and now in the House committee-passed FY17 report to issue a final guidance document on how office-use compounding can be done in a manner consistent with 503A and which protects both patient safety and patient access to critical medications. We look forward to your prompt response.
Washington, D.C. -- A Wyoming Federal Judge has struck down the Obama Administration’s final rule on hydraulic fracturing, arguing that the BLM and the Department of Interior lack the authority to regulate fracking. Rep. Chris Stewart (R-Utah), released the following statement regarding the ruling:
“This is a huge win for protecting the constitutionally mandated separation of powers and reining in executive overreach. For almost eight years, the Obama Administration has ignored the Constitution, going around Congress to implement heavy-handed regulations without any authority. In this ruling, Judge Skyadhl affirmed that Congress, not the President or Washington bureaucrats, must create the laws.”
“This technology boom has played a huge rule in furthering economic recovery, in spite of the administration’s efforts to stop it. I’m glad that with this ruling, fracking can continue to play a strong role in our push for domestic energy independence.”
Washington, D.C. –The Veterans TRICARE Choice Act, introduced by Rep. Chris Stewart (R-Utah) and Rep. Tulsi Gabbard (D-Hawaii) is one step closer to becoming law, receiving approval by the House Ways and Means Committee today during a committee Mark Up.
This bill, H.R. 5458, is a bipartisan, common sense piece of legislation that allows veterans to contribute to Health Savings Accounts if they so choose.
Health Savings Accounts have proven to be an effective way to pay for medical costs and proactively save for future medical expenses. These have become increasingly popular healthcare plans in the private sector. But under current federal law, it is illegal for a TRICARE-eligible veteran to participate in an HSA program. The Veterans TRICARE Choice Act simply gives veterans the choice to voluntarily pause their TRICARE benefits in order to participate in an HSA program.
“I would like to thank the House Ways and Means Committee for approving this legislation, making it one step closer to being law” Congressman Stewart said. “As a former Air Force Officer, I know first hand about the sacrifices made by veterans and their families. When they leave the military and enter the private workforce, they shouldn’t be denied opportunities given to non-veteran employees. It’s important that we honor our veterans by ensuring that they have access to the best healthcare options for themselves and their families.”
“As a Soldier and a veteran, I have seen firsthand the tremendous sacrifice our veterans and their families make in service to our country,” said Rep. Tulsi Gabbard (HI-02). That service should never have a limiting effect on a veteran’s healthcare options. Yet right now, veterans have to opt out of TRICARE permanently to access other health care options. This legislation rightly gives our veterans the ability to choose the best healthcare options for themselves and their families.”
Washington, D.C. – Today, Rep. Chris Stewart’s (R-Utah) amendment to block the creation of new national monuments in Utah and in other areas, passed during a U.S. House Interior Appropriations Committee Mark Up. This amendment will now be officially included in the Interior Appropriations Bill, which is expected to be voted on by House of Representatives this summer.
This is a critical amendment as speculation is rising that President Obama plans to designate a new Bears Ears National Monument, ignoring local opposition and Rep. Bishop’s Public Land Initiative.
“With the passage of this amendment, we are one step closer to preventing any President from creating new national monuments in Utah and in other areas where there is strong opposition,” Stewart said. “I am a strong supporter of preserving our national treasures, but when dealing with such huge areas of land – like has been proposed with Bears Ears – I believe we must have local and congressional input. Using the Antiquities Act as a political weapon is bad policy and furthers the distrust that exists between Americans and the Federal government.”
Watch Congressman Stewart defend his amendment in the following videos:
Rep. Stewart’s Opening Statement:
Rep. Stewart’s Closing Statement:
The specific amendment language can be found here.Read More
Washington, DC- Congressman Chris Stewart (R-Utah) released the following statement regarding the horrific attack in Orlando:
"Once again innocent Americans have suffered a horrendous attack. We can't allow this to become the new normal.
The FBI is investigating the Orlando mass shooting as a terrorist attack. As a member of the House Intelligence Committee I will do everything in my power to ensure that we successfully fight Islamic Terrorism- both at home and abroad.
This attack serves as a reminder that Islamic terrorism is a threat to every community in America. We know Islamic terrorists target Christians, the LGBT community, women and a variety of other groups. They are nothing but evil and they must be stopped. Which is why we as national leaders need to strengthen our national security to prevent future attacks.
I hope you will join me in not only sending our thoughts and prayers to everyone affected by today's terrible events, but also join me in seeking ways to bolster our security at home and abroad."Read More
Washington, D.C. – Today, at an Interior Appropriations subcommittee mark up, Rep. Chris Stewart (R-Utah), urged his colleagues to help him find a bipartisan solution to the overpopulation of wild horses in the West.
“If you care about these animals like I do, we can’t just continue with what’s happening,” Stewart said. “By the BLM’s own estimate it’s going to cost a billion dollars to care for these [Wild Horses] in the next few years. There are more than 67,000 of them now, and they expect that number to double in the next 4 years. We could throw our hands up in the air and say ‘this is too hard, we can’t fix it’, but that seems unacceptable. We are hoping we can find some bipartisan agreement and do something meaningful."
In 2015, Rep. Stewart also introduced the Wild Horse Oversight Act, which would allow states to take over the management of wild horses and burros.
Washington, D.C. – Today, the National Defense Authorization Act (NDAA) passed the House of Representatives with key provisions that are critical for Utah. The bill provides for state management of Sage-Grouse, includes Rep. Chris Stewart’s bill that strengthens Utah’s Test and Training Range, and includes land exchanges that will be a boon to Utah’s public education funding.
“This legislation is critical, both for our country and for Utah’s significant role in national security,” Stewart said. “Through this bill, we support our men and women in uniform and provide the weapons and training they need to protect us and our allies. It also includes several big victories for Utah by including my bill improving the Utah Test and Training Range. Those changes will allow the Air Force to better test the F-35, resolve ownership of roads surrounding the training range, execute land exchanges that will decrease the amount of federally-owned land in Utah and provide increased funding for Utah’s public education. Overall, it’s a big win for our national security and for Utah.”
Specifically, the NDAA does the following:
Washington, D.C. – In honor of National Police Week, Rep. Chris Stewart (R-Utah), gave a speech on the House Floor commemorating local law enforcement officers. He specifically honored a Salt Lake City Police Officer, Ben Hone, who saved two female college students from a violent home evasion last year. You can watch the speech here:
Congressman Stewart’s remarks:
Mr. Speaker, along with many of my colleagues I rise today to honor National Police Week.
One of the favorite things that I get to do as a member of Congress is to ride with police officers as they go about their duties. From St. George to Salt Lake City, I’ve had the opportunity to do this.
Sadly, many in our society and particularly among the press have been highly critical of law enforcement officers. Now I recognize that not all law enforcement officers are perfect. People make mistakes. We all do. But we can’t let the mistakes of a few, tarnish the name of such a noble and a brave profession.
Such criticism of police efforts doesn’t come without a cost. It forces the officers to pull back. To become overly cautious. To view every encounter that they may have through the prism of a lens of a media event.
And what is the result of this? We now know that crime rates have been rising across the country and interestingly and sadly, they are rising in some of the poorest communities. The communities that most need the help of an effective police force.
Now more than ever we need brave men and woman who are willing to serve and to protect.
And as I’ve said, I’ve had the chance to go on several ride-a-longs with local police departments. Again and again, I’ve been impressed with their hard work, their professionalism, their willingness to put themselves at risk to protect other people.
There’s a great example of this. I’m reminded of the heroic actions of Officer Hone, a police officer who last year saved two young girls in Salt Lake City.
A disturbed man, who had recently been released from prison and was on drugs, broke into the home of two sisters, both of them college students. He began to viciously attack them, and he took a knife and he attempted to take their lives.
Fortunately, Officer Hone was in the area, and he heard the screams of these young girls, and just seconds before the intruder expected to take the life of one of them, this heroic police officer quickly diffused the situation, literally saving her life.
Brea, the sister who was saved, said of the officer, “He was so professional and calm. Right when we made eye contact, I knew I was safe. It's a miracle that he had so much composure. He was our angel.”
This is just one example of the thousands of courageous police officers we have in America. I’m proud to live in a country where professionals are ready to put their lives at risk in order to serve and to protect members of their community.
Let us honor these police officers, their courage, their selflessness, their dedication. Let us honor them not just this week, but frankly all year round for the sacrifice that they give for us.
And with that, Mr. Speaker, I yield back.
Washington, DC – Rep. Chris Stewart (R-Utah), issued the following statement after the Obama Administration issued a directive requiring public schools to open access to bathrooms for transgender students:
“Just a day after a court struck down the President’s latest overreach, he’s at it again, threatening to withhold funding to public schools that don’t comply with his views on gender identity. We can all agree that every student should be treated with kindness and respect. Bullying of any kind is unacceptable. But this is the heavy hand of the federal government and yet another example of the President trying to circumvent Congress. A better way to solve this would be to use the blueprint from Utah’s anti-discrimination laws. That should be the model for the nation.”Read More
323 Cannon HOB
Washington, DC 20515
Chris Stewart is the Congressman from Utah’s Second Congressional District. He is a No. 1 New York Times best-selling and national award-winning author, world-record-setting Air Force pilot, and the former owner/CEO of a small business.
Chris is one of ten children and grew up on a dairy farm in Cache Valley. He graduated from Utah State University, where he earned his degree in economics. Upon graduation, Chris joined the United States Air Force where he was the Distinguished Graduate (top of his class) in both Officer Training School and Undergraduate Pilot Training. He served for fourteen years as a pilot in the Air Force, flying both rescue helicopters and the B-1B bomber. He holds three world speed records, including the world’s record for the fastest non-stop flight around the world.
Chris is a prolific author having written 17 books, several of which have become national best-sellers, and have been published in six different countries.
Before being elected to Congress, Chris served as president and CEO of the Shipley Group, a nationally recognized firm for consulting expertise in energy and the environment. He and his wife, Evie, are the parents of six children.
Chris now serves as a member of House Appropriations Committee.
Retweeted by RepChrisStewart
Retweeted by RepChrisStewart
My friends in Utah should go to this. Rep. Stewart is a very thoughtful and interesting man. https://t.co/F1OYD5Xf7b
Retweeted by RepChrisStewart
Thank you, Representative Chris Stewart! https://t.co/KtzF3EoATX