Leading FDA Is an Impossible Job Right Now. Heidi Overton Could Still Do It Well.

Before this administration, I never would have thought attitude and temperament mattered much when choosing an FDA commissioner. I now realize that it does.

From the 1970s through 2025, all the commissioners have been smart, honest, eager for success, and highly demanding. None were shrill in articulating FDA policy or indifferent to the importance of consistency and transparency in FDA’s decisions. Each supported FDA staff.

At last week’s confirmation hearing, the administration’s nominee for FDA commissioner, Heidi Overton, MD, PhD, displayed a cooperative tone, a respectful demeanor, and an understanding that FDA’s decisions must conform to law, science, and process. This aligns her with the agency’s past leadership and distinguishes her from her immediate predecessor, who lacked these qualities and understanding.

The commissioner has an impossible job, especially in this administration. With that in mind, I saw and heard enough to believe Overton can be a productive commissioner if confirmed.

Confirmation Hearings Are Theater

Years ago, as a Senate staffer, I learned that confirmation hearings are theater. Everyone has a role, and the nominee’s credentials are, at most, a minor part of the script.

Senators from both parties ask pointed questions about issues important to them or their constituents. The goal is to prompt the nominee to pre-commit to specific positions and actions that will limit their options once in office.

In turn, the nominee needs to give helpful answers to win votes without giving too much of the future away. Not surprisingly, nominees load up on ways to deflect questions they can’t or don’t want to answer.

As I describe in the following section, Overton did provide some valuable (and encouraging) information about her views at the hearing. Nonetheless, most of the hearing was taken up by non-answers and deflections. This is fairly standard in high-stakes confirmation hearings, not something to hold against Overton.

Inside the Hearing: A Commitment to Follow the Law

True to form, a bipartisan group of senators on the Health, Education, Labor & Pensions (HELP) Committee sought to create daylight between Overton and her bosses-to-be, President Trump and HHS Secretary Robert F. Kennedy Jr.

To many of the questions, Overton kept returning to a twin mantra: (1) anything deemed safe and effective by the FDA remains so until the FDA reviews and acts on contrary evidence; and (2) the agency needs to continue to follow the standards in the law with regard to safety and efficacy determinations.

With that understanding, she acknowledged the safety of all FDA-approved vaccines. She explicitly addressed the safety and importance of the measles, mumps, and rubella vaccine. That was the moment when she came closest to directly contradicting the president, who recently claimed the trivalent MMR vaccine was lethal.

The “twin mantra” approach didn’t work as well for mifepristone (Mifeprex). She deflected most questions by arguing that judgment is premature given the product’s ongoing safety evaluation. However, Sen. Josh Hawley (R-Mo.), the Senate’s leading critic of the abortifacient, noted that the FDA’s position — recently articulated in court — does not defend the agency’s prior judgments.

Overton’s twin mantras speak to core FDA values and the agency’s global reputation as the world’s leading food and drug regulator. They are on message for FDA employees and stakeholders. Not to quibble, but I hoped she would also endorse science-based decision-making, a compatible but not identical standard to her mantras.

No Set Qualifications for FDA Commissioner

At another time, Overton might have had an easier path to becoming the next FDA commissioner. She would arrive with a commendable urgency to accelerate medical product development through evidence-based standards; craft sensible food policies; rejuvenate FDA’s staff; and champion the advisory committee system and other processes that guide FDA decisions.

As demonstrated at her confirmation hearing, Overton brings the requisite qualities to fill the commissioner post: she is knowledgeable, articulate, eager to do a good job, and committed to the laws, science, and process that should always guide FDA decisions. She also spoke positively about working closely with FDA’s expert scientific staff.

Her credentials also have weaknesses: she has no experience managing a large, complex organization, and has a narrow range of prior work experience.

In my judgment, when all factors are considered, Overton is sufficiently qualified for the role — closer to the historical norm and distinct from her predecessor.

Overton’s Trump and Kennedy Problem

We must, of course, address the elephant in the room. What is most notable about Overton’s nomination is not her credentials or policy positions, but rather, the roles of Kennedy and President Trump.

Before 2025, no commissioner had to grapple with bosses who routinely commented on public health and medical issues about which they had neither been briefed nor possessed independent expertise.

To level-set: there are always disagreements between the FDA commissioner and HHS, the Office of Management and Budget (OMB), and the White House. Most of them are worked out quietly, behind the scenes, often by technical and policy staff.

However, every commissioner has confronted OMB and White House resistance on a specific issue and had to personally carry the agency’s case to their bosses. Sometimes they win, sometimes they must compromise, and occasionally they lose outright. However, this is rarely HHS, OMB, and the White House trying to impose broad policy on the FDA; rather, it is mostly HHS and OMB reviewing policies and documents and trying to steer FDA’s decisions.

The situation facing Overton is different from that. In our current environment, we see the president and the HHS secretary frequently opining on FDA issues. They clearly have an FDA agenda.

As a result, Overton (or any other FDA nominee that might succeed her) is not likely to be a bulwark against all their untoward initiatives. She may even agree with some or have to pick her battles. Like commissioners before her, she will win some, compromise some, and probably lose some. The difference is likely to be in the volume of the issues she has to address and the stridency her bosses may bring to them.

Critically, she seems to grasp — at least regarding vaccines — that Trump and Kennedy are entitled to their own opinions but not to their own scientific facts. Her mantras, if repeated and honored, are the right place for her defense of the agency’s science and integrity.

What Happens Next?

To become commissioner, Overton will need approval from the committee and the full Senate. That process cannot begin until November 9, when the Senate returns from its pre-election recess.

As noted, my support for Overton rests on her cooperative tone, respectful demeanor, and recognition that the FDA is bound by law, science, and process. She can oversee meaningful reforms while remaining a loyal advocate for the science, process, and staff that are the agency’s DNA. This aligns her with prior FDA commissioners but not with her immediate predecessor.