Makary Resigns as FDA Commissioner

FDA Commissioner Marty Makary, MD, MPH, resigned on Tuesday after just over a year at the agency and days of speculation about whether he’d be fired.

Kyle Diamantas, the agency’s deputy commissioner for food, was named as the acting FDA commissioner.

The news was first reported by Politico, though the Wall Street Journal reported last week that President Trump had signed off on a plan to fire the embattled commissioner.

While the White House did have to sign off on the plan, HHS Secretary Robert F. Kennedy Jr. made the call, Politico reported. “It was really Secretary Kennedy himself who made this decision,” an administration official told the outlet.

Makary’s 13 months at the agency have been marked by turmoil, including mass layoffs and significant churn among top agency officials, including the firing, then re-hiring, of Vinay Prasad, MD, MPH, as the director of FDA’s Center for Biologics Evaluation and Research. Prasad left the agency last month for a second time.

The agency’s top drug regulator position has been a revolving cast under Makary’s leadership, with brief tenures from George Tidmarsh, MD, PhD; Richard Pazdur, MD; and Jacqueline Corrigan-Curay, MD. Currently, Tracy Beth Hoeg, MD, PhD, holds the position of acting director.

Makary, a former editor-in-chief at MedPage Today, also faced a host of pressures from every direction — pharmaceutical companies, Kennedy, Republicans, and even Trump himself.

Companies grew frustrated with what they’ve described as inconsistent reviews of their products. Makary had to consider Kennedy’s interests in scrutinizing the safety of vaccines, drugs, and food additives. Republicans want the agency to restrict access to the abortion pill mifepristone (Mifeprex), a review of which some have alleged Makary is slow-walking. Trump wanted Makary to authorize flavored vapes and other nicotine products — which he finally did earlier this month.

Makary also oversaw a number of controversial initiatives at the agency, including the creation of the Commissioner’s National Priority Voucher; cutting the number of required studies for drug approval from two to one; and incorporating Bayesian statistical methods into clinical trials of drugs and biologics.

He and Prasad also developed a new approach to COVID vaccine approvals, allowing immunogenicity endpoints for high-risk groups, while calling for randomized controlled trials for those at lower risk. They also rolled back wider approval for COVID shots, adding limitations for certain groups.

And in perhaps their most controversial move, Prasad claimed — without evidence — in an internal memo that the agency had linked COVID shots to the deaths of 10 kids.

It’s not clear what will happen to all of these initiatives once Makary leaves. Many of the programs he introduced haven’t gone through the federal rulemaking process and easily could be overturned by his successor.

Diamantas appears to be the top internal candidate to run the agency, but others from the first Trump administration appear to be in the running, including former U.S. assistant secretary for health Brett Giroir, MD, and former FDA Commissioner Stephen Hahn, MD, according to Axios.

Makary is the second major health agency chief fired by the Trump administration, following CDC Director Susan Monarez, PhD, last August.

The Associated Press contributed to this story.