Marty Makary Resigns as FDA Commissioner

CNBC reported Tuesday that FDA Commissioner Dr. Marty Makary has resigned from his post. President Donald Trump confirmed the departure via Truth Social. He described Makary as a “wonderful man” and said he would go on to lead a good life.

A Deputy Steps Into an Unstable Agency

Trump named Kyle Diamantas, the agency’s former top food official, as acting commissioner. The administration expects to put forward a formal nominee within the coming weeks. A senior White House official cautioned, however, that it was too early to name specific candidates.

Health and Human Services Secretary Robert F. Kennedy Jr. made the call to replace Makary, the same official confirmed. The official said no single incident drove the departure. It was instead a buildup of unresolved problems across multiple fronts.

Also Read: What RFK Jr.’s HHS Role Means for Drug and Vaccine Policy

A Tenure Marked by Dysfunction and Backlash

Makary, a surgical oncologist, took charge of the agency responsible for regulating food, drugs, and medical devices roughly fourteen months ago. His time in the role was defined by internal turmoil. Senior career scientists departed in numbers, among them longtime cancer regulator Dr. Richard Pazdur, who publicly cited Makary’s leadership as the reason for his exit. Staff morale fell sharply following layoffs and an erosion of trust in management.

The White House grew frustrated with what it viewed as sluggish movement on policy priorities, including the push to legalize flavored vapes. The anti-abortion group Susan B. Anthony Pro-Life America separately called for Makary’s removal over his handling of the abortion pill mifepristone. Makary had reportedly delayed a safety review of the drug, which can be mailed to states that restrict abortion. His successor inherits that unfinished review.

Pharma Industry Watches With Unease

Despite ongoing tensions over drug rejections, pharmaceutical companies appear nervous rather than relieved by the leadership change. The industry is in active negotiations over the reauthorization of the Prescription Drug User Fee Act, the mechanism through which drugmakers fund FDA drug reviews. Disruption at the top of the agency adds uncertainty to those talks.

One of Makary’s most divisive hires, Vinay Prasad, had already departed at the end of April. Prasad oversaw vaccines and biotech treatments and drew sustained criticism. His rejection of a Huntington’s disease gene therapy from uniQure and his initial refusal to review a Moderna flu vaccine both drew industry fire. The FDA later reversed the Moderna decision.

Makary’s resignation leaves the agency without confirmed leadership at a particularly sensitive regulatory moment.

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