Following news that started brewing last week, Dr Marty Makary has officially resigned from his post as commissioner of the US Food and Drug Administration (FDA), with Kyle Diamantas, who has been at the helm of the Food division, set to take the role of acting FDA commissioner.
According to multiple reports, including the Wall Street Journal, President Donald Trump was considering firing Makary due to dissatisfaction over his work at the agency, including his handling of decisions involving the authorisation of fruit-flavoured e-cigarettes and the abortion pill mifepristone.
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Makary became the 27th commissioner of the FDA in April 2025, and was at the helm of the agency for just over a year.
Diamantas is set to take over in an acting role, according to Politico, which was among several news outlets that broke the news of Makary’s resignation.
FDA unrest continues
Makary’s resignation comes following a turbulent few months at the FDA. Dr Vinay Prasad former head of the Center for Biologics Regulation and Evaluation (CBER), left his role at the agency for the second time in April 2026. Prasad was responsible in part for the recent FDA moves on incorporating the plausible mechanism and single clinical trial pathways.
Previously, Prasad resigned from the FDA in July 2025 amid backlash on his approach to cell and gene therapy approvals, which many called conservative, particularly around his regulatory approach to Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, Elevidys (delandistrogene moxeparvovec). He was then reinstated as CBER head just two weeks later at the request of the FDA.
Other high-profile officials have either resigned or been ousted from their positions in recent months. This includes seasoned oncology regulator, Dr Richard Padzur, who left the FDA after less than a month as head of the Center for Drugs Regulation and Evaluation (CDER) in December 2025. Padzur was later replaced by Dr Tracy Beth Hoeg, who became the fifth person to lead CDER in 2025.
Before Padzur came George Tidmarsh, who resigned after being placed on administrative leave in November, after concerns were raised around his personal conduct.
At CBER, Prasad was appointed to run the division after the previous lead, Dr Peter Marks, resigned after he and the Health and Human Services (HHS) Secretary Robert F Kennedy Jr (RFK Jr) disagreed on vaccine policy. At the time, Marks said that RFK Jr did not desire “truth and transparency”, but rather “subservient confirmation of his misinformation and lies”.
Alongside high-profile leadership changes, the agency has also been grappling with drug review delays, which some are attributing to mass layoffs, while also contending with accusations of its politicisation from ex-FDA staffers.
