04.05.17

Murray Questions President Trump’s Nominee to Lead FDA About Potential Conflicts of Interest, Commitment to Providing Independent Leadership

Murray, top Democrat on the Senate HELP Committee, today pressed Dr. Scott Gottlieb about his “unprecedented financial entanglements”

 

Murray at today’s hearing: I am concerned about “how you can provide the strong, independent, and science-based leadership that families in my state and across the country rightly expect”

 

Dr. Gottlieb also faced questions about his record on women’s health issues, protecting kids from tobacco products, and past troubling statements made on FDA’s core mission

 

(Washington, D.C.) – Senator Patty Murray (D-WA), top Democrat on the Senate Health, Education, Labor, and Pensions (HELP) Committee, today questioned Dr. Scott Gottlieb, nominee for Commissioner of the Food and Drug Administration (FDA), about his commitment to “ensure independent, science-based decision-making at the FDA” at a hearing to consider his nomination.

 

“In the limited time we have had to review your professional history and background, I have grown increasingly concerned about whether you can withstand political pressure pushing you to ignore science by upholding the gold standard, and if you can lead the FDA in an unbiased way, given your unprecedented industry ties,” said Senator Murray in her opening statement.

 

During the hearing, Senator Murray pressed Dr. Gottlieb for answers on his time at the FDA under the Bush Administration, when the Administration “ignored science” and made a decision on emergency contraception, known as “Plan B,” based on purely ideological grounds.

 

“Dr. Gottlieb, you defended the Administration’s ideological position on “behind the counter” options for Plan B, allowing politics to interfere directly with women’s access to health services they need.”

 

Senator Murray questioned Dr. Gottlieb’s work serving on the board of various medical companies, particularly two medical lab companies that could be directly impacted by potential decisions made by Dr. Gottlieb in regards to FDA’s jurisdiction.  

 

“It troubles me greatly you appear to be investing in and advising a company, and then using your public platform to promote policies that will benefit that company in the future.”

 

Senator Murray also asked Dr. Gottlieb to directly address other priorities under the FDA’s jurisdiction, such as keeping tobacco out of the hands of children, ensuring a safe and nutritious food supply, and other efforts to protect public health.

 

“These are all core responsibilities at the FDA, and I would be very concerned if you simply aligned with President Trump’s extreme vision and take orders from his Administration.”

 

Full text of Senator Murray’s opening statement:

 

Thank you, Chairman Alexander.

 

Dr. Gottlieb, I want to welcome you and your family. Thank you for being here and for your willingness to serve. I’ll start by expressing my disappointment about the limited time we have had to review Dr. Gottlieb’s committee paperwork.

 

We got Dr. Gottlieb’s full paperwork on Friday, meaning we have had just a handful of days to fully understand the extent of Dr. Gottlieb’s unprecedented financial entanglements with the industries he would regulate as FDA Commissioner, find and review the more than 800 publications Dr. Gottlieb has listed, and delve into the wealth of companies and products that raise concerns about potential conflicts of interest.

 

Chairman Alexander, as you know, I have repeatedly stressed, privately and publicly, the importance of a thorough and complete vetting process for each of President Trump’s nominees.

 

Fully vetting the Administration’s nominees shouldn’t be a priority for Democrats alone. Both parties deserve to make fully informed decisions about the potential leaders of the critical departments and agencies we oversee.

 

Unfortunately, the inexplicable rush to advance this nomination falls far short of that basic standard. So I will continue to push for a thorough review of Dr. Gottlieb’s nomination. And Dr. Gottlieb, I hope you will give clear and thorough responses to any follow-up questions to today’s discussion.

 

I appreciate that you responded to my letter requesting additional information on your clients. And I hope that you are committed to leading an agency that responds to and works with Congress. 

 

Because I have to say I’ve been disheartened by the unprecedented lack of responsiveness by this Administration. Throughout several nomination processes, Democrats have requested documents and additional information to assist in our vetting. 

 

Disappointingly, Secretary Price failed to respond to a single one of the questions this Committee asked him following his confirmation hearing.  And we have yet to receive a response to even one of the inquiries we have sent since his confirmation. Across the Administration, this is the new normal.

 

No responsiveness. No transparency. No accountability. It’s frightening and it’s frustrating—and it simply can’t go on.  I hope—given the importance of the work of this agency—that if confirmed, you will not follow this trend.  

 

Our constituents rely on the work of the FDA every single day. They trust that the food they buy from the grocery store is safe; that when they go to the emergency room, the drugs and medical devices used in their care have been held to the highest standards of approval; and that the FDA’s decisions are based on science, not politics or ideology—the gold standard.

 

As you know well, Dr. Gottlieb, I have a long history of holding very firm on this particular point. To me, it is critical that the FDA have strong, independent leadership—especially in light of President Trump’s apparent disregard for public health. 

 

Dr. Gottlieb, in the limited time we have had to review your professional history and background, I have grown increasingly concerned about whether you can withstand political pressure pushing you to ignore science by upholding the gold standard, and if you can lead the FDA in an unbiased way, given your unprecedented industry ties.

 

I will ask you to address these concerns here today. I am very interested in how you would ensure independent, science-based decision-making at the FDA if you are confirmed.

 

During your time at the FDA under the Bush Administration, then-Senator Clinton and I fought long and hard to ensure that emergency contraception, known as “Plan B,” would be sold over-the-counter to all age groups, consistent with expert recommendations.

 

The Administration ignored the science and made a decision based on purely ideological grounds—a choice that a GAO report later called “unprecedented.” Dr. Gottlieb, you defended the Administration’s ideological position on “behind the counter” options for Plan B, allowing politics to interfere directly with women’s access to health services they need.

 

Given the Trump Administration’s clear willingness to skirt ethics rules and pressure federal employees to jam their policy through, not to mention their commitment to undermining women’s access to birth control and other health services, I find this aspect of your professional history especially troubling.

 

And, as I mentioned, I am also very concerned about your unprecedented financial entanglements—especially given this Administration’s awful record on this issue from President Trump, on down.

 

One example of my concerns—in 2012, you were quoted in the Washington Post stating: “If consumers can track their blood-sugar levels using pen and paper, why should the government have to clear an app that does the same thing more reliably?”

 

Now—you’re an investor in Glytec, a medical technology company that developed software that allows patients and doctors to manage and adjust insulin therapy using smart phones and devices—and received an FDA approval for this software in in 2012. 

 

And not surprisingly, you have also served on Glytec’s board since 2013. Another example—FDA and Congress have both been engaged in an ongoing debate about the regulation of medical tests.

 

In a column related to embattled lab company Theranos, you argued that the regulation of these tests is best left outside of FDA’s jurisdiction—all while serving on the board of two medical lab companies that would be directly impacted by your preferred regulatory scheme. And I could go on.

 

Dr. Gottlieb, it troubles me greatly you appear to be investing in and advising a company, and then using your public platform to promote policies that will benefit that company in the future. 

 

And meanwhile, reports continue to surface about Secretary Price’s questionable actions on behalf of companies he in which he invested. Just last Friday, a ProPublica story indicated he had lobbied the Department of Health and Human Services on behalf of companies—on the very same day his broker invested in them on his behalf. 

 

And when the Trump Administration released its financial disclosures just a few days ago, we learned of more financial entanglements in the health sector. 

 

President Trump’s top economic advisor, Gary Cohn, has millions of dollars in financial investments in a number of medical technology, drug, and tobacco companies.  And President Trump’s pick to lead the Justice Department’s Anti-Trust Division—which decides whether to approve the proposed $54 billion Anthem-Cigna merger—received hundreds of thousands of dollars as a lobbyist on behalf of Anthem.

 

You can see there is a concerning pattern here, and we don’t need more of it. I know that, if confirmed, you have agreed to recuse yourself for one year from decisions involving some companies in which you’re invested. But I struggle to see how this will ensure your views and decisions will not be shaped by your investments.

 

Our HELP Committee research shows that companies that you invested in have more than 60 drugs that could come before the FDA for approval, and companies you worked for have interests in over 120 drugs that are currently being tested. That is unprecedented.

 

Finally, Dr. Gottlieb, the vast majority of your professional work is focused on drugs and medical devices—and I have some concerns with your published positions on a number of important issues.

 

On marketing and communications by drug companies for “off-label” or unapproved uses of their products, you were quoted in 2006 saying, “efforts to limit prescription and scientific exchange to indications only specified on a label could [slow] the most important advances in 21'st century medicine.”

 

I would argue that over the last 11 years we have seen incredible advances in medicine, while also ensuring that only truthful and non-misleading information is given to doctors and patients.

 

I am concerned about what you describe as regulatory overreach by FDA, including your opposition to the regulation of medical apps, and your rejection of risk evaluation and mitigation strategies, or REMS, meant to protect patients—FDA’s central mission.

 

I also am eager to hear how you will implement recent legislation passed by this Committee, including 21st Century Cures and the Drug Quality and Security Act, passed to regulate compounding pharmacies and build a modern supply chain.

 

And your plans to encourage a more robust market for generics and biosimilars to help reduce the astronomically high cost of prescription drugs. But the FDA does far more than drugs and devices.

 

So I hope in this hearing you will directly address priorities like keeping tobacco out of the hands of children, ensuring a safe and nutritious food supply, and other efforts to protect public health.

 

These are all core responsibilities at the FDA, and I would be very concerned if you simply aligned with President Trump’s extreme vision and take orders from his Administration.

 

I again appreciate you and your family joining us today. And I look forward to hearing from you about whether and how you can provide the strong, independent, and science-based leadership that families in my state and across the country rightly expect.

 

I’ll now turn it back over to Chairman Alexander.

 

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