Alexander: Scott Gottlieb Has Impressive Qualifications and Is the Right Person to Lead FDA and Its “Vital Mission”

FDA affects nearly every single American and regulates about a quarter of all consumer spending in the United States—over $4 trillion annually

Posted on April 5, 2017

The Food and Drug Administration has always been important, but there’s never been a more important time to capitalize on the significant funding Congress has given to medical research—and to realize the promise of 21st Century Cures.”

WASHINGTON, D.C., April 5 – At today’s Senate health committee hearing, Chairman Lamar Alexander (R-Tenn.) said that Dr. Scott Gottlieb has “impressive qualifications from nearly every perspective” and is the right person to lead the Food and Drug Administration (FDA) and its “vital mission” for patients.

“The Food and Drug Administration has always been important,” Alexander said, “but there’s never been a more important time to capitalize on the significant funding Congress has given to medical research—and to realize the promise of 21st Century Cures. …The FDA affects nearly every single American and regulates about a quarter of all consumer spending in the United States—over $4 trillion annually. It is responsible for product areas as diverse as prescription drugs for humans and animals, medical devices, biologics, dietary supplements, cosmetics, over-the-counter medications, food, and tobacco products.”

Alexander continued, “If confirmed to lead the Food and Drug Administration as its Commissioner, you will be in charge of steering the agency responsible for assuring the safety and effectiveness of our nation’s medical products and protecting our country’s food supply. And my hope is that you will help move the agency forward – so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on.”

“Your first order of business will be to work with us on the reauthorization of the user fee agreements,” Alexander said. “We’ve had over 15 bipartisan briefings on the user fees going back to late 2015. Senator Murray and I have held two bipartisan hearings on the reauthorization—our second one yesterday. I support quickly moving the reauthorization recommendations sent to us in January and I am committed to working with the administration and all members of this committee to reauthorize the user fees before August 1.”

Alexander’s full prepared remarks are below:

Last year, the most important legislation that Congress passed was the 21st Century Cures Act. Those aren’t my words – they are Majority Leader McConnell’s.

The reason it was such an important bill is that it will drive forward medical research – extraordinary medical miracles that have the potential to affect every American family.

Dr. Francis Collins at NIH has talked about some of the discoveries that are possible in the next decade: non-addictive painkillers; hearts rebuilt from our own stem cells; a universal flu vaccine; an HIV/AIDS vaccine; an artificial pancreas for diabetes patients who have spent decades injecting themselves with insulin.

The key to making these miracles a reality is not just investment in research – but a regulatory process that is efficient and effective enough to bring safe discoveries to patients in a timely way.

The Food and Drug Administration has always been important, but there’s never been a more important time to capitalize on the significant funding Congress has given to medical research—and to realize the promise of 21st Century Cures.

Dr. Gottlieb, congratulations on your nomination. Welcome to you and to your family members who are here. I enjoyed having the opportunity to visit with you in my office.

If confirmed to lead the Food and Drug Administration (FDA) as its Commissioner, you will be in charge of steering the agency responsible for assuring the safety and effectiveness of our nation’s medical products and protecting our country’s food supply.

And my hope is that you will help move the agency forward – so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on.

The FDA affects nearly every single American and regulates about a quarter of all consumer spending in the United States—over $4 trillion annually.

It is responsible for product areas as diverse as prescription drugs for humans and animals, medical devices, biologics, dietary supplements, cosmetics, over-the-counter medications, food, and tobacco products.

That is a vital mission, and we all want to make sure that the right person is leading it.

The president has nominated you to do that job, and like every full-time nominee, you’ve been through an exhaustive process to make sure that you do not have any conflicts of interest or other problems in your background.

The president announced your nomination on March 10, after an extensive vetting process by the White House and the FBI.

Your official nomination was received on March 27.

On March 28, this committee received a letter from the Office of Government Ethics, which carefully reviewed your financial information and found that, with several recusals which you have committed to do, you are “in compliance with applicable laws and regulations governing conflicts of interest.” 

In accordance with our committee rules, you submitted your committee paperwork to senators on March 31, five days before this hearing.

You have offered to meet with every senator on this committee. You have met with every Democratic senator and all but two Republican senators.

And that brings us to today’s hearing. You come here today with impressive qualifications from nearly every perspective.

You were a practicing physician and hospitalist for many years. You received your medical degree at Mount Sinai School of Medicine and completing your residency in internal medicine at the Mount Sinai Hospital.

You have held three positions in the Department of Health and Human Services, including two positions at the FDA as Deputy Commissioner from 2005 to 2007 and before that in 2003 to 2004 as a senior advisor to Commissioner Mark McClellan, and as the FDA’s Director of Medical Policy Development.

Since your time in government, you have studied health policy as a Resident Fellow at the American Enterprise Institute.

You are also a prolific writer and speaker on medical innovation, and no stranger to testifying before Congress.

You have testified in front of Congress eighteen times on a variety of issues including the drug approval process, drug costs, drug shortages, importation, and health care reform.

You are also a cancer survivor. You know firsthand how medical treatments affect patients and their families.

I am eager to hear your views today on both the user fee reauthorizations and 21st Century Cures.

Your first order of business will be to work with us on the reauthorization of the user fee agreements.

We’ve had over 15 bipartisan briefings on the user fees going back to late 2015.

Senator Murray and I have held two bipartisan hearings on the reauthorization—our second one yesterday.

I support quickly moving the reauthorization recommendations sent to us in January, and I am committed to working with the administration and all members of this committee to reauthorize the user fees before August 1.

In addition to drugs and medical devices, FDA is responsible for protecting our nation’s food supply and working to reduce the number of people who get sick from foodborne illness.

Roughly 48 million Americans each year get sick from the food they eat, according to the Centers for Disease Control and Prevention.

But technology is improving and changing the way we improve food safety—it holds the potential to reduce foodborne illnesses and deaths. For example, we can use whole genome sequencing to identify a foodborne illness outbreak.

The Food Safety Modernization Act, which became law in 2011, is continuing to be implemented. It will be important for you to ensure regulations are risk-based and least burdensome, and enable the diverse and growing food industry to be partners in protecting individuals from foodborne illness.

FDA is a large and diverse organization that faces management challenges.

When I asked Dr. Califf his top priority, it was to give FDA the authority to hire and pay people to do what the agency needs to do.

We included that authority in 21st Century Cures.

I’m concerned about the administration’s hiring freeze and how you will deal with it, if confirmed.

Thank you for being here, and I look forward to hearing your testimony on these important issues.

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