Drew Armstrong at Endpoints News brilliantly titled his summary of the Makary era: “An Impossible Job, Done Badly.” (here)
I could not agree more.
Unfortunately, nothing about the “impossible job” of FDA leadership has been made any easier or better by Dr. Makary’s departure. The hot, divisive, ongoing issues (e.g., vaccine policy, tobacco, drug approval standards, and mifepristone) have not suddenly disappeared. In addition, by compelling Dr. Makary to authorize flavored vaping, President Trump and Secretary Kennedy have reinforced the impression that they will put political and electoral advantage ahead of science and public health 1.
All we can reasonably hope for is that the impossible job will be done better by whoever serves as Acting Commissioner, and then by the next confirmed FDA Commissioner. We would all welcome stable leadership that values the expertise of staff and outside advisors. We can hope for more rational, transparent, and science-based decision-making.
Traditionally, the Commissioner has been a policy leader, a manager, and a consensus builder, whose primary responsibility is to create support (or at least acceptance) for the agency’s actions. The idea of “FDA Commissioner vs. the World” has become familiar but is both anathema to good government and doomed to failure.
Under the current circumstances, Mr. Diamantas is a solid stabilizing choice as “Acting Commissioner.” He has earned a lot of respect in a relatively short time at the agency. I expect that to carry over to his responsibilities as Acting Commissioner. I am not yet concerned that his relative lack of experience at the agency and lack of scientific or medical training are impediments.
As a lawyer, he may be more inclined to follow the agency’s traditional decision-making processes, which have served both the agency and its stakeholders well for many years. I would not expect him to be comfortable with the fiat decision-making that has predominated over the last 13 months.
As a non-scientist, he may be more inclined to listen to the many deeply knowledgeable and expert FDA staff and advisors who are the backbone of the agency’s global leadership. One of the endearing qualities of FDA’s persona is its commitment to explaining its decisions in procedural as well as medical and scientific terms. That starts with listening.
The most important reason to wish Mr. Diamantas’ success: he is likely to be acting for many months. The only exception I can imagine is if Sara Brenner returns as acting, given that she has scientific credentials and Mr. Diamantas does not. Regardless of who is acting, no one should expect a permanent Commissioner anytime soon.2
Here’s why:
Under the Federal Vacancies Reform Act (FVRA) (acus.gov), an acting official may generally serve for 210 days, absent a submitted nomination that would extend the clock while the nomination is pending. Using the May 12 vacancy date, the statutory window runs into mid-November 2026, meaning Diamantas can legally remain in place past the mid-term elections. Submitting a pro-forma nomination to the Senate for someone other than Mr. Diamantas could also be used to extend his acting tenure.
Even if the White House were inclined to move quickly with a nominee and had someone in mind, Senate dynamics make confirmation before November unlikely. The chamber is sharply divided on FDA-related issues—including abortion-related drug policy, vaccine oversight, vaping regulation, and food safety—and contested confirmations are hard to schedule now and will become harder the closer we get to the mid-terms.
It is possible that the Senate will not even be in session in October and the first half of November. Further, there is no guarantee that a lame-duck (post-election) session of Congress will occur. Even if it does, the agenda may be limited or may not address any partisan issues or nominations.
We may still have an Acting Commissioner in February/March of next year.
Recent experience across federal public-health agencies reinforces this outlook. The administration has struggled to secure permanent leadership for other high-profile health posts, including CDC Director and Surgeon General. This reflects how difficult it has become to identify candidates with credentials that are both scientifically and medically strong and politically acceptable to a closely divided Senate and an Executive Branch skeptical of the value of public health.
There is also precedent for prolonged acting leadership at FDA. Janet Woodcock served as Acting Commissioner from January 2021 until February 2022, and Ned Sharpless and Brett Giroir served as Acting Commissioners for most of 2019. There was a 15-month gap in 2005-2006. However regrettable, extended interim leadership is no longer unusual for the agency (here).
Generally, interim leadership is cautious, has a limited appetite for major initiatives, and pursues incremental decision-making. This reflects that an acting commissioner has the authority to act but only in a context in which it is inherently temporary. How this plays out under Trump/Kennedy leadership is not predictable.
Summary
No matter what you think of Dr. Makary or his time in office, his firing (or forced resignation) doesn’t change the fundamental difficulties of being FDA Commissioner under President Trump and HHS Secretary Kennedy. His departure gives the appearance of change, but leaves untouched the fundamental tension between FDA’s statutory, functional, and moral responsibilities and the goals, governing style, and legacy of this Administration.
Dr. Makary’s temporary successor, Kyle Diamantas, faces the same impossible situation. However, he will probably have the opportunity to implement more orderly management structures and decision-making processes, which would be welcome improvements.
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1 The vaping incident may not have been reported accurately. A reader pointed to Nicotine Insider, which dissects the FDA correspondence. Notably, the product involved has age-restrictive capacity and FDA staff support. The story is complicated and we may not know it all. Regardless, I am still not comfortable with the President determining an outcome rather than insisting that the commissioner investigate or order a review.
2 After this column was published, AgencyIQ reported that there were no front-runners to succeed Dr. Makary, but “that could change quickly as senior Trump administration officials aim to identify his successor within the next few weeks, according to CNN.”
I am sure the Administration wants to fill the vacancy quickly and will be working hard to do so. I hope they succeed. However, a prolonged vacancy is plausible, both politically and historically. Every stakeholder ought to be prepared for the possibility, notwithstanding an endless stream of earnest statements like the one reported by CNN.
Note: I sometimes use artificial intelligence in drafting this column. My primary tool is Microsoft Co-Pilot. I review and verify all findings, interpretations, and final wording.”
