Michael Burgess

Michael Burgess

TEXAS' 26th DISTRICT

Burgess Opening Statement "21st Century Cures: Examining the Regulation of Laboratory Developed Tests"

2014/09/08

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), vice chairman of the House Energy and Commerce Subcommittee on Health, today issued the following opening statement at a hearing titled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests”:

I have attended every Cures event in DC and several across the nation.

Repeatedly we hear of the potential of genomic medicine to understand illness, quickly diagnosis it and target treatment. This has been embraced in a bipartisan manner.

I strongly believe in this potential. Here’s an example:

A few months ago, CDC briefed my staff on an emerging global health threat in the form of a virus. They had sequenced the virus, provided information to researchers and even knew where in the particular country’s jungle the virus originated. It was impressive to say the least.

Here’s one more: Back in 2009, H1N1, a subtype of the Influenza A virus, spread rapidly.  

During the first week of the outbreak, 16 laboratories had LDTs that could identify H1N1 from other H1 viruses.  Most results were available within 24 hours. The speed helped inform public health reactions.  

The FDA had no approved commercial kit. If they had, under the proposed framework – even if it was 15 years old and inferior – these LDTs would have been blocked from doctors and public health officials. 

FDA regulation of tests like these will be burdensome and will slow the ability of clinical laboratories to develop tests that can allow us to respond to public health crises. It is also duplicative – Congress already established a regulatory framework applicable to labs and laboratory testing, known as CLIA. 

However, I have conceded additional review of certain tests may be warranted.  Previously, I introduced legislation to meet patient needs and ensure tests are accurate, reliable and clinically valid by making improvements to CLIA.

I authored section 1143 of the Food Drug Safety & Innovation Act so we would be able to discuss how patients, the practice of medicine, innovation and the economy would all be harmed if FDA tried to fit LDTs into the misaligned definition of medical device.
I fundamentally believe FDA has no statutory authority to regulate LDTs.

For FDA to have jurisdiction, it must be a traditional device and be commercially distributed among states. LDTs do not fall under either category.  

Professional medical services are not regulated by FDA. 

If they start to be, we are effectively opening the door to the federal regulation of the practice of medicine. I adamantly reject and will vehemently oppose that notion.

In addition to these significant jurisdictional issues, the process FDA is considering is of great concern. Even if the courts determined FDA authority over LDTs, the agency would need to amend its current regulations through rulemaking.  

The FDCA, the Administrative Procedures Act and the Supreme Court all require disseminating rules to modify current regulation or to create legally enforceable regulations. 

Instead, the FDA continues on its jurisdictional power grab by attacking innovation, threatening professional practice and risking countless jobs in order to claim authority over all they see. They are doing this even at the expense of allowing the core mission of the FDA to suffer as a consequence. 

I can’t think of a worse result: denying patients and doctors innovative tests while redirecting resources that could be used to approve the next miracle medical device or drug.

I thank you for the hearing and yield. 

For more information on this hearing, click here

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Burgess Statement on Gov. Rick Perry Indictment

2014/08/18

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) today issued the following statement in response to the indictment of Texas Governor Rick Perry for allegedly abusing his power by threatening to veto funding for a state anti-corruption unit after District Attorney Rosemary Lehmberg (D) refused to resign following her arrest for drunken driving:

“Governor Perry acted well within his rights by exercising veto power in direct response to criminal activities of a county district attorney. This indictment is intended to harm Perry’s career and reputation as he wraps up his tenure as our state’s longest serving Governor.  Perry has served Texas well – our economy is booming, more businesses move to Texas from other locations around the country every month, and his response to the immigration crisis at our border shows leadership and integrity.  It is time we focus on more important issues – like jobs and the economy – and commend Perry for the positive work he has done as Governor of Texas.”

For more on this issue, click here

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Burgess Introduces Legislation to Send Military Supplies to Ukraine

2014/08/01

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) on Thursday introduced legislation to supply the Ukrainian government with supplies and equipment to aid in their continued struggle against the Russian separatist army.

Burgess, who serves on the Helsinki Commission and recently traveled to Ukraine, said it has become increasingly clear the Ukrainian army is in dire need of supplies. 

“The Obama administration has done nothing to help the Ukrainians when they need it most,”
Burgess said. “We have yet to supply Ukraine with the requisite equipment, despite a request to do so by President Poroshenko. Ukraine is our ally; we need to start treating them as such. After all, a strong and free Ukraine is in the best interest of the United States.”

The bill, H.R. 5315, would create a lend-lease program in which the U.S. government would lease specific military equipment and supplies that is coming back from the wars in Iraq and Afghanistan to Ukraine. The legislation states unequivocally that no part of this should be construed as an Authorization for Use of Military Force. 

“As the wars in Iraq and Afghanistan draw to a close, the equipment that was used is coming back to the U.S. in droves,” Burgess continued. “There would be no better use of these weapons and supplies than to lease them to those who are in dire need: the Ukrainian government.”

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MEDIA ADVISORY: Burgess to Host Town Hall Meetings Next Week

2014/08/01

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) today announced he will host two town hall meetings in the 26th District next week. They will be held on August 4 in Little Elm and August 5 in Trophy Club.

WHAT: Town Hall Meetings
WHEN: Monday, August 4, 2014 and Tuesday, August 5, 2014 from 7-8:30 p.m.
WHERE: 
MONDAY: Little Elm High School Auditorium -- 1900 Walker Lane, Little Elm, TX 75068
TUESDAY: Byron Nelson High School Auditorium – 2775 Bobcat Blvd., Trophy Club, TX 76262

Dr. Burgess will discuss what he has been working on in Congress and answer questions from constituents. 

More information may be found on Dr. Burgess’ official website homepage at www.burgess.house.gov.
             
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Burgess Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs)

2014/07/31

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), vice chairman of the House Energy and Commerce Subcommittee on Health, today responded to the Food and Drug Administration’s (FDA) notification to Congress that it will release draft guidance to regulate laboratory developed tests (LDTs) with the following statement:

“Applying FDA’s regulatory approach to LDTs is redundant, will stifle innovation and will require additional taxpayer funding for the FDA. To the extent concerns about ‘higher-risk’ tests exist; these can be addressed at no cost to the government through a modernization of The Clinical Laboratory Improvement Amendments (CLIA). 

“Given the negative impact these policies – if pursued – could have on innovation, I am glad I was able to secure this notification requirement within the Food and Drug Administration Safety and Innovation Act of 2012. LDTs are not medical device products sold through interstate commerce. They are services provided only to the ordering healthcare provider and offered only by labs that validate and develop them. Professional medical services are not regulated by FDA. More importantly, the question of agency jurisdiction over LDTs has never been legally clarified.  LDTs neither constitute “medical devices” nor are commercially distributed among states – both requirements for FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA).

“FDA is the subject of much criticism from industry groups who are already under their jurisdiction. As such, they are overburdened and take too long to approve products, which increases uncertainty for companies and negatively impacts innovation, as well as patient access to new treatments and devices. If LDTs were regulated as medical devices by FDA, it would significantly tax an already overtaxed agency and stifle access to these important tests.

“The Energy & Commerce Committee is continuing to develop the 21st Century Cures initiative and explore how we can encourage innovation. We are also looking into ways to increase our ability to detect, treat and cure disease. I fear today’s move by the FDA moves in the opposite direction and I look forward to raising this issue often in the coming months.”


Burgess’ provision within the Food and Drug Administration Safety and Innovation Act of 2012 ensured that FDA would have to give Congress 60 days’ notice and a full description before enacting regulations such as this one. For more information, click here

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Burgess, Nadler Introduce Bipartisan Bill to Protect Organ Donors

2014/07/30

Washington, D.C. – Congressmen Michael C. Burgess, M.D. (R-TX) and Jerrold Nadler (D-NY) today introduced the Living Donor Protection Act, a bill to promote organ donation and protect the rights of living organ donors.

“Every year, thousands of living Americans donate kidneys, livers, and other organs to save the lives of family members, friends, and complete strangers struggling with chronic, life-threatening illnesses,” the Congressmen said. “Organ donation cuts health care costs as much as two-thirds by reducing the need for dialysis and other expensive medical interventions to treat chronic illnesses. Yet, after taking this heroic step to save a life, living organ donors may unfortunately face discrimination when they try to take medical leave or buy insurance. Our bill would address that injustice.”

The Family and Medical Leave Act (FMLA) does not specify that living organ donors can take unpaid leave to recover from their donation and does not guarantee that donors will have a job waiting for them after surgery. Further, according to a 2007 study in the American Journal of Transplantation, as many as 11% of living organ donors experience difficulty securing or paying for insurance after their procedures because of discriminatory practices.

The Living Donor Protection Act would promote organ donation and protect living organ donors in three ways:

1)      Prohibits life, disability, and long term care insurance companies from denying or limiting coverage and from charging higher premiums for living organ donors; 
2)      Clarifies that living organ donors may use FMLA time to recover from the surgeries and procedures involved in their donation; and 
3)      Directs HHS to update their materials on live organ donation to reflect these new protections and encourage more individuals to consider donating an organ

“Rather than putting roadblocks in the way of living organ donation, Congress should encourage more individuals to become living donors and protect the rights of those donors to receive the insurance and medical leave they need,” the Congressmen added.

The bill has support from numerous groups that advocate on behalf of organ transplantation.

“The National Kidney Foundation commends Congressmen Jerrold Nadler (D-NY) and Michael Burgess (R-TX) for their leadership in expanding opportunities for living organ donation that will ultimately help reduce the national shortage of organs,” Bruce Skyer, National Kidney Foundation (NKF) Chief Executive Officer, said. “NKF has long-advocated for additional protections for living donors, including prohibitions against denial of coverage or charging higher premiums for life insurance, disability insurance or long-term care insurance.  NKF has also maintained that people should be able to donate an organ without fear of losing their jobs. The additional protections under the Family and Medical Leave Act contained in this proposed legislation will enable more people to give the gift of life by donating their kidneys. The NKF is grateful for Congressman Nadler’s living donation efforts and for Congressman Burgess’s ongoing leadership on transplant initiatives.”

“Living donors should not have to worry about or suffer financial loss as a result of their benevolence,” Dr. David Reich, chairman of the American Society of Transplant Surgeons (ASTS) Legislative Committee, said. Dr. Alan Langnas, ASTS President,  noted, “The Living Donor Protection Act of 2014 represents another important step toward the full removal of financial disincentives for living organ donors. Representatives Nadler and Burgess are championing sensible legislation and we wholeheartedly support their efforts.”

“Living organ donation, the gift of a healthy organ given to a patient with kidney, lung or liver failure, is simply an amazing act of human kindness and part of the miracle of transplantation,” American Society of Transplantation(AST) President Dr. Daniel Salomon, M.D., from the Scripps Center for Organ Transplantation. said. “The Living Donor Protection Act of 2014 supports the future of this form of organ donation by considering the special needs of the living donors and protecting their best interests while they are making this wonderful gift to another human being in need. The American Society of Transplantation (AST) applauds the leadership of Congressmen Jerrold Nadler and Michael Burgess for introducing this important and necessary organ donor protection legislation.”

“NATCO is very pleased to have Congressmen Burgess’and Nadler’s continued understanding and support of organ donation and transplantation issues made even more apparent through the introduction of this legislation,” Organization for Transplant Professionals (NATCO) President Carrie Lindower said. “It will eliminate the punishment of denied coverage and increased premiums living donors too often receive for simply wishing to give the gift of life.  Additionally, it further supports living donors by making organ donation surgery a part of the Family Medical Leave Act as it should be.” 

“I strongly support Congressmen Jerrold Nadler’s and Michael Burgess’s Living Donor Protection Act of 2014,” David Cohen, chairman of the Public Policy Committee within the American Society of Transplantation (AST) said. “This is a common sense approach to protect and promote the gift of living organ donation here at Columbia University Medical Center and around the nation.” 

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Texas GOP to Obama: 'A Country That Has Lost Control of Its Borders Has Lost Control of Its Future'

2014/07/24

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) today signed on to a letter to President Obama asking him to address the current national security and humanitarian crisis on the Texas border.

In the letter, which was signed by the entire Texas Republican delegation, the members wrote that only the president has the authority to stop the surge of illegal immigration by minors by enforcing current immigration laws.

The members asked President Obama to take five actions: suspend his Deferred Action for Childhood Arrivals (DACA) executive order, end the policy that gives convicted criminal immigrants a free pass into the U.S., improve cooperation with local law enforcement agencies, crack down on immigration fraud and expedite the processing and removal illegal immigrants who are apprehended on the border.

“Your administration has used existing laws as an excuse for your failure to end the national security and humanitarian crisis on our southern border,” the members wrote. “However, the majority of immigrants apprehended at the border during this crisis can be legally repatriated immediately. Instead, you have permitted almost all to remain in the United States, further encouraging illegal immigration.”

Taking the five actions described in the letter will “save lives and discourage those you have enticed to enter illegally through your current policies,” the members concluded.

Burgess has been active on the issue of unaccompanied children on the Texas border. He traveled to Lackland Air Force Base in San Antonio to tour the facility holding the recent immigrants in June, and traveled to McAllen, Texas to tour the border and intake facility. As a physician, he has expressed concern about the health and cost of care for these minors and has repeatedly called on President Obama to strengthen his position on this issue and visit the border himself.

Last week, he introduced legislation that would direct the president to reduce foreign aid from Guatemala, Honduras, El Salvador and Mexico by $15,000 per child who originated from that particular country. 

A copy of the letter may be found here

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In Case You Missed It: Burgess Statement on Halbig v. Burwell

2014/07/22

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), vice-chairman of the House Energy and Commerce Subcommittee on Health, today took to the House floor to react to the Halbig v. Burwell decision, which upheld a challenge to Obamacare health insurance subsidies being granted in the federal exchange.



Click here to watch. Click here to read his remarks as prepared for delivery. 
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U.S. Helsinki Commission Calls for Investigation, Accountability for Terrorist Act in Ukraine Separatist Region

2014/07/21

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), a member of the Commission on Security and Cooperation in Europe (the U.S. Helsinki Commission) joined the Commission in calling for unfettered access to the crash site of the Malaysian Airlines MH17, which is territory controlled by separatists in Ukraine. The members said this access will allow for the establishment of responsibility for the killings and will bring justice when said parties are held accountable.

“The downing of Malaysian Air flight 17 is an unspeakable tragedy. It did not have to happen and those responsible must be held accountable,” Senator Ben Cardin (D-MD), Chairman of the U.S. Helsinki Commission, said. “As we mourn for those lost and share our heartfelt prayers with the victims' families, I encourage international efforts to establish what happened and who was responsible. In particular, I welcome the efforts and courage of the OSCE’s Special Monitoring Mission team which has made its way to the crash site. I am extremely disappointed to learn that they were forced to depart after a mere 75 minutes due to aggression by the Moscow-sponsored separatists.  
 
"This heinous crime is a direct consequence of Russia’s unjustified aggression in Ukraine which began with the annexation of Crimea nearly five months ago and has continued in two regions in eastern Ukraine, in violation of OSCE and other international norms. It is a direct result of Putin’s destabilization of Ukraine. The top three leaders of the so-called Donetsk People’s Republic are all Russian citizens, and two of them are Russian intelligence operatives," Cardin continued. “Russia has continued to sponsor these terrorists with heavy weapons, equipment and men continuing to flow across the Russian border into Ukraine. If Russian involvement is confirmed, serious consideration needs to be given to designating the Donetsk People’s Republic a Foreign Terrorist Organization and the Russian Federation a State Sponsor of Terrorism.” 
 
Representative Chris Smith (NJ-04), co-chairman of the Commission, said, “Our hearts go out to the family and friends of the 298 innocent victims, including 80 children, who perished, likely at the hands of Russian operatives. I urge the President to vigorously work for full access for identification and removal of victims’ remains, and international investigation. The entire area should be treated as a crime scene as the plane appears to have been shot down by a surface-to-air missile launched from a separatist-controlled area. This follows a pattern of actions where the rebels have shot down Ukrainian military planes and helicopters, most recently a Ukrainian military cargo plane earlier this week, for which they took credit.”
 
“I am profoundly saddened and outraged at the senseless loss of innocent civilians on Malaysian Airlines Flight 17,” Burgess said. “I am extremely disturbed by the lack of access for international observers and first responders and by reports of looting and of people contaminating the crash site.  Not only must we be able to conduct a proper investigation, but the remains of the victims must be treated properly and with the utmost respect. I am also troubled by reports that there may be other efforts by the separatists and Russian authorities to cover up what really happened.”

Burgess recently traveled to Ukraine to monitor their elections. More information may be found here and here

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The Commission on Security and Cooperation in Europe, also known as the U.S. Helsinki Commission, is an independent agency of the Federal Government charged with monitoring compliance with the Helsinki Accords and advancing comprehensive security through promotion of human rights, democracy, and economic, environmental and military cooperation in 57 countries. The Commission consists of nine members from the U.S. Senate, nine from the House of Representatives, and one member each from the Departments of State, Defense, and Commerce.
 
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Burgess Introduces Unaccompanied Children Assistance Control Act

2014/07/21

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) last week introduced a bill that would help the United States better handle the rising cost of the tens of thousands of unaccompanied minors who are crossing into the United States from Central America.

The Unaccompanied Alien Children Assistance Control Act, H.R. 5141, would direct the president to reduce foreign aid from Guatemala, Honduras, El Salvador and Mexico by $15,000 per child who originated from that particular country. The money saved by this bill could then be redirected to assist states with the rising costs of these children, as well as aid in border security efforts.

“President Obama’s open door policy on immigration has resulted in a huge strain on our system,” Burgess said. “With the number of unaccompanied immigrant children crossing into the U.S. expected to grow to six figures by next year, it is clear that something must be done to offset the tremendous cost that this crisis on our border is costing Texans and citizen of other states. The U.S. already gives generously in foreign aid to these countries, but we cannot continue to do so if our limited resources are dedicated to caring for these migrant children who have been sent to our country illegally. This bill is an important first step in dealing with the crisis that is before us in a common sense way.”

Burgess has been active on the issue of unaccompanied children on the Texas border. He traveled to Lackland Air Force Base in San Antonio to tour the facility holding the recent immigrants in June, and travelled to McAllen, Texas to tour the border and intake facility. As a physician, he has expressed concern about the health and cost of care for these minors and has repeatedly called on President Obama to strengthen his position on this issue and visit the border himself

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Contact Information

2336 Rayburn HOB
Washington, DC 20515
Phone 202-225-7772
Fax 202-225-2919
burgess.house.gov

Committee Assignments

Energy and Commerce

Rules

After spending nearly three decades practicing medicine in North Texas I have served the constituents of the 26th District since 2003 in the United States House of Representatives.

I currently serve on the prestigious House Energy and Commerce Committee and in the 113th Congress, 2013 and 2014, will serve as the Vice Chairman of both the Subcommittee on Health and the Oversight and Investigations Subcommittee, and as a member of the Energy and Power Subcommittee. In addition, I am a member of the Rules Committee and the Helsinki Commission. In 2009, I founded, and currently serve as Co-Chair of the Congressional Health Caucus.

Because of my medical background, I have been a strong advocate for health care legislation aimed at reducing health care costs, improving choices, reforming liability laws to put the needs of patients first, and ensuring there are enough doctors in the public and private sector to care for America’s patients and veterans. I have played an important role in bipartisan efforts to ensure the safety of food, drugs, and consumer products, and have introduced legislation to strengthen our ability to stop dangerous products from coming into the country.

As a Member of Congress representing one of the fastest growing areas of the country, transportation is also a top priority. In 2005, I successfully amended the Highway Bill to include development credits, design-build, and environmental streamlining. During my time on Capitol Hill, I have worked to build, maintain, and improve the safety of our roads, bridges, air service, and transit in the North Texas region.

A fiscal conservative, I believe Americans deserve a federal government that is more efficient, effective, less costly, and always transparent. I follow a strict adherence to the Constitution, and oppose unnecessary expansion of the federal government’s control over Americans’ personal freedoms. Instead, I believe in giving people more control over their lives and their money.

During my time on Capitol Hill, I have earned a reputation as a problem-solver who seeks sensible solutions to the challenges Americans face and have received several awards including: the Guardian of Small Business award by the National Federation of Independent Business (NFIB); the Spirit of Enterprise award by the U.S. Chamber of Commerce; and the Taxpayer Hero award from the Council for Citizens Against Government Waste; among others.

Today, I represent the majority of Denton County, and parts of Dallas County and Tarrant County. I was raised in Denton, and attended The Selwyn School, graduating in 1968 as valedictorian. In addition, I graduated with both an undergraduate and a master’s degree from North Texas State University, now the University of North Texas.

I received my M.D. from the University of Texas Medical School in Houston, and completed my residency programs at Parkland Hospital in Dallas. I also received a master’s degree in Medical Management from the University of Texas at   Dallas, and in May of 2009 was awarded an honorary Doctorate of Public Service from the University of North Texas Health Sciences Center.

My wife, Laura, and I have been married for 39 years. We have three children and two grandsons.


Serving With

Louie Gohmert

TEXAS' 1st DISTRICT

Ted Poe

TEXAS' 2nd DISTRICT

Sam Johnson

TEXAS' 3rd DISTRICT

Ralph Hall

TEXAS' 4th DISTRICT

Jeb Hensarling

TEXAS' 5th DISTRICT

Joe Barton

TEXAS' 6th DISTRICT

John Culberson

TEXAS' 7th DISTRICT

Kevin Brady

TEXAS' 8th DISTRICT

Michael McCaul

TEXAS' 10th DISTRICT

Michael Conaway

TEXAS' 11th DISTRICT

Kay Granger

TEXAS' 12th DISTRICT

Mac Thornberry

TEXAS' 13th DISTRICT

Randy Weber

TEXAS' 14th DISTRICT

Bill Flores

TEXAS' 17th DISTRICT

Randy Neugebauer

TEXAS' 19th DISTRICT

Lamar Smith

TEXAS' 21st DISTRICT

Pete Olson

TEXAS' 22nd DISTRICT

Kenny Marchant

TEXAS' 24th DISTRICT

Roger Williams

TEXAS' 25th DISTRICT

Blake Farenthold

TEXAS' 27th DISTRICT

John Carter

TEXAS' 31st DISTRICT

Pete Sessions

TEXAS' 32nd DISTRICT

Steve Stockman

TEXAS' 36th DISTRICT

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