Marty Makary, M.D., is resigning as FDA commissioner Tuesday, ending a brief but tumultuous tenure marked by mounting criticism from all sides.
Makary’s resignation, as reported by Politico based on an anonymous administration official, follows reports at the end of last week that President Trump had signed off on a plan to fire the FDA leader that he installed in April 2025.
Kyle Diamantas, the FDA deputy commissioner for food, will lead the agency in an acting capacity, Politico reports.
President Donald Trump seemed to confirm Makary’s departure when speaking to reporters Tuesday, although he stopped short of clarifying whether he had fired the commissioner directly.
“Well, I don’t want to say, but Marty’s a great guy, he’s a friend of mine, he’s a wonderful man and he’s going to be off,” Trump said, as quoted by The Hill.
The President also added that “the assistant, the deputy, is taking over temporarily” as the hunt for a permanent replacement for Makary commences.
Trump also admitted that Makary was “having some difficulty,” according to The Hill.
In recent months, Makary has reportedly drawn the ire of the White house for resisting the President’s push to clear fruit-flavored e-cigarettes.
In a series of articles, The Wall Street Journal editorial board mounted a campaign for his ouster over some recent FDA decisions on drug approvals.
Pro-life groups have also blasted Makary, arguing he was not tough enough to restrict the abortion pill mifepristone.
Lawmakers questioned his Commissioner’s National Priority Review Voucher (CNPV) pilot as a potential conduit for introducing political intervention and favoritism into the evaluation of medicines.
Even the biopharma industry, which is typically hesitant to critique the very agency that can easily put their business in a chokehold, has voiced frustration. Under Makary’s watch, the sector has grown weary of rapid leadership turnover and massive brain drain at the FDA, as well as seemingly inconsistent regulatory standards and a habit of overruling career scientists.
But eventually, the decision to push Makary out was made by HHS Secretary Robert F. Kennedy Jr., Politico reports, citing an unnamed administration official. Kennedy has long been dissatisfied with Makary, having reportedly considered checking the FDA commissioner’s authority and reducing him to a figurehead role.
Within the HHS, Makary reportedly clashed with Chris Klomp, HHS chief counselor and the director of Medicare, over some personnel decisions, Politico recently reported, citing a senior HHS official.
The resignation comes as Makary was slated to testify before the Senate Appropriations Committee Wednesday on the FDA’s fiscal year 2027 budget request.
Makary has made several legislative proposals in his budget report, including creating an expedited pathway for drugmakers to begin first-in-human clinical trials. This policy, along with others such as CNPV and the plausible mechanism framework, has drawn support from the Trump administration and will therefore likely survive the leadership transition.