Marty Makary Resigns as FDA Commissioner
FDA commissioner Marty Makary has resigned, CNBC reported Tuesday, ending a turbulent stint leading the agency responsible for regulating the country’s food, drugs and medical devices.
President Donald Trump confirmed the departure in a Truth Social post. He named Kyle Diamantas, previously the FDA’s top food official, as acting commissioner while a permanent replacement is sought. Trump described Makary warmly to reporters, saying he would “go on and lead a good life.”
A Resignation Built From Many Pressures
A senior administration official confirmed Makary submitted his resignation on Tuesday. Health and Human Services Secretary Robert F. Kennedy Jr. made the call to replace him, according to the official. No single issue drove the departure, the official said. Instead, a series of compounding problems eroded confidence in Makary’s leadership.
The White House had reportedly grown frustrated with what it viewed as insufficient urgency on key policy priorities. Chief among them was the legalization of flavored vaping products. Anti-abortion groups also publicly demanded his removal over the FDA’s handling of mifepristone, the abortion pill that can be mailed to patients in states with restricted access. Makary had reportedly slowed a safety review of the drug. His successor inherits that review.
Industry Backlash and Internal Dysfunction
Drug companies and physicians pushed back hard on several of Makary’s regulatory decisions. High-profile rejections of rare disease therapies drew particular criticism. Staff morale deteriorated sharply following a wave of layoffs and the departure of experienced agency scientists. Longtime cancer regulator Dr. Richard Pazdur cited Makary’s leadership directly when he left.
One of Makary’s most contested appointments was Vinay Prasad, who oversaw vaccines and biotech reviews before stepping down in late April. Prasad drew fire from biotech firms and former health officials alike. His decision to initially block a Moderna flu shot review was later reversed by the agency. He also rejected a gene therapy for Huntington’s disease from uniQure, a move the company disputed publicly.
What Comes Next for the FDA
The pharmaceutical industry is watching the transition closely. Drugmakers are currently in negotiations over the reauthorization of the Prescription Drug User Fee Act, which governs the fees companies pay to fund FDA reviews. Any prolonged leadership vacuum could complicate those talks.
The administration expects to name a permanent nominee within weeks, though the senior official cautioned that no names are ready to surface yet. The acting commissioner, Diamantas, will hold the agency steady in the interim.
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