With President Trump’s nomination of Dr. Heidi Overton as FDA Commissioner and the pending confirmation hearing, it’s worth asking for clarification about what qualifications are required to meet the weighty responsibilities of the position. Are there any positions, policies, or approaches to the job that are disqualifying?
In the initial wave of reaction to Dr. Overton’s nomination, it became clear that many people have lots of questions and concerns. A likely flashpoint is her stance on vaccine policy, especially given the recent measles outbreaks.
I also expect hard questions about the use of mifepristone to end a pregnancy; about FDA’s interface with the MAHA food agenda; and about Dr. Overton’s lack of management experience. There will certainly be questions about the degree of agency independence from HHS and White House directives.
These are, of course, appropriate questions. However, I see a more encompassing concern that I hope the Senate Health, Education, Labor, and Pensions (HELP) Committee will address in its questions….and rely upon in its vote.
Specifically, the Committee should explore how Dr. Overton intends to lead the FDA’s decision-making process. Chairman Cassidy should ask: Do you agree that FDA should utilize science-based decision-making? How would you facilitate that? Do you agree that the FDA should be transparent about how and why it came to a particular decision?
Such questions have become necessary because her predecessor often made fiat-like decisions with little or no regard for evidence….and called it “gold standard science.” He also violated multiple process norms and public notice requirements, especially regarding unbiased reviews….and called it “radical transparency.” In fact, he was neither scientific nor transparent in his leadership of the agency.
As a result, FDA has become increasingly inconsistent and opaque to patients, consumers, and industry. An FDA that has been famously committed to “no surprises” has suddenly become a major source of uncertainty and chaos.
None of that should ever occur again.
FDA has never wavered in its core belief: the agency’s global credibility rests on its commitment to listening to all voices and its willingness to share guidance documents and make public statements that disclose its thinking and can be used to explain its decisions.
The current predicament at FDA is widely understood. As my friend and public health advocate, Paul Kim, has said: “All the norms have been thrown out the window, so we don’t know what underlies an agency decision….even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”
FDA affects every American every day, often multiple times. This reflects the agency’s vast responsibilities and extraordinary economic impact. Its fair, science-based decision-making process needs to be preserved and reinforced. The FDA has been seen as a global leader for decades. That standing is now at risk.
The confirmation hearing is the place where these questions should be asked and the answers judged. The Senate needs to take responsibility for a fair, effective, and science-based FDA.
