Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing
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President Trump nominated Johns Hopkin Professor Martin Makary to be the next Commissioner of FDA. His confirmation hearing is Thursday, March 6 at 10 a.m. The livestream will be here.
As with confirmation hearings generally, the ostensible purpose is to determine Dr. Makary’s fitness to be FDA Commissioner. I expect the Senate HELP committee to conclude that he is qualified. The Senate will then confirm him in March or early April.
A confirmation hearing is a lot of work for Senators and staff, just to prove Dr. Makary is qualified…something everybody knew beforehand. He is qualified. Why bother with a hearing?
Historically, the real purpose of confirmation hearings is for Senators to extract commitments from nominees that narrow what they can do once in office[1]. Those can be:
relatively benign, such as Dr. Gottlieb agreeing in 2017 to review “a persistent issue with the FDA not properly clearing medical device shipments” or
incredibly divisive, such as FDA’s role in the accessibility of mifepristone, the key component of medical abortions.
All this week you will see articles like: “the five questions that I want Senators to ask Dr. Makary” and “the five toughest questions that Dr. Makary will face.”
Instead, this column goes back to look at Gottlieb’s confirmation hearings in April of 2017—suspecting there will be parallels to what Dr. Makary will face on Thursday.
Gottlieb Confirmation Hearing (2017). Scott Gottlieb Confirmation Hearing Transcript
Senate Outcome: Confirmed 57 to 42 on May 9, 2017. Republicans were in the majority and all voted yes. They were joined by Democratic Senators: Bennet, Carper, Coons, Heitkamp, King (Independent), and Nelson. The forty-two nay votes were all Democrats.
At the confirmation hearing, Gottlieb received a positive introduction by his home state Senator (Chris Murphy), who subsequently voted against him.
Parallels Between 2017 and 2025: Dr. Gottlieb was nominated at the beginning of President’s Trump’s first term. In both years, the Senate was closely divided with a slim Republican majority.
Many of the same issues that concerned Senators then, still concern Senators today: abortion, tobacco, women’s access to birth control, opioids, trial design and standards, biosimilars, off label marketing, pandemic preparedness and medical counter measures, and close ties between FDA and regulated industries…just to name a few. The most frequently discussed issues were 1/ opioids, pain, and addiction, and 2/ health care costs, generics, biosimilars. It will be interesting to see if these are still the top priorities.
The testiest exchange was probably Senator Bernie Sanders trying to extract a commitment from Dr. Gottlieb to support drug re-importation, to align himself with a Trump campaign promise to advance re-importation (pages 17-18 of the transcript).
Most Unexpected Finding: I had forgotten the chaos and norm-breaking that occurred in 2017. There is an eerie similarity to today. In her opening remarks at the hearing, Ranking Member Patty at Murray challenged Dr. Gottlieb to be more forthright “Given the Trump administration’s clear willingness to skirt ethics’ rules and pressure Federal employees to jam their policies through….” (page 4 of the transcript).
Implementation of New Laws Can Stretch into Decades. Senators were interested in how Dr. Gottlieb intended to implement the Drug Quality and Security Act of 2013 (DQSA), the Biologics Price Competition and Innovation Act of 2010 (BPCIA), and the Food Safety Modernization Act of 2010 (FSMA). While there has been much progress since 2017, all of these complex laws still have implementation issues that may well come up at Dr. Makary’s confirmation hearing.
The Most Important Exchange (from Ranking Member Patty Murray)(page 4 of the transcript):
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.
Dr. Gottlieb’s response (in his testimony) (Page 8 and 9 of the transcript)
If confirmed, I will lead the FDA as an impartial and passionate advocate for public health. I know what is at stake here. People’s lives are literally on the line when it comes to the decisions FDA makes, its oversight, and its enforcement of Congress’ laws.
The American people deserve to trust that the agency is led in an impartial manner—guided only by the science that informs its work—and an abiding faith to the public health.
That is the mandate by which I would lead this agency, if I were fortunate enough to win your approval. I will respect the intent of Congress. I will make sure the laws you passed are implemented in a timely fashion and in the way you intended.
Every decision I make will be guided by the advice of career experts. I will be guided by the scientific rigor that the public deserves, and the rigor that the hard challenges before this agency demand. It is to take on these challenges that I seek this role.
The FDA stakeholder community will respond with cheers and a deep sigh of relief if Dr. Makary makes the same assurances.
It is acknowledged that—at least so far--- this year’s batch of nominees seem to be less concerned about fulfilling commitments made to Senators during their confirmation hearings.