Dr. Marty Makary resigned as FDA commissioner on Tuesday, ending a tenure that had drawn criticism from drugmakers, patient groups, members of his own agency, and the White House, according to a report by CNBC.
President Donald Trump announced the departure in a post on Truth Social, saying Kyle Diamantas, who previously served as the top food official at the FDA, would step in as acting commissioner. In remarks to reporters, Trump called Makary a "wonderful man" and said, "He's going to go on, and he's going to lead a good life."
Trump shared a second post showing what he described as a resignation text from Makary, in which the departing commissioner highlighted the FDA's priority review process that sped up some drug approvals, among other changes he said he had made to the agency.
A senior administration official confirmed the resignation, and said Health and Human Services Secretary Robert F. Kennedy Jr. made the call to replace Makary. The administration hopes to name a permanent nominee in the coming weeks, though the official said it was too early to identify potential replacements.
Makary, a surgical oncologist who became publicly known for criticizing the government's response to the Covid pandemic, had led the FDA for more than a year. His time at the agency was marked by internal turmoil and mounting backlash over regulatory decisions, including high-profile rejections of some rare disease treatments. At the same time, the White House had grown increasingly impatient with what it viewed as his slow movement on key policy priorities, including the legalization of flavored vapes.
The influential Susan B. Anthony Pro-Life America organization had also called for Makary's removal over the FDA's handling of the abortion pill mifepristone. Makary reportedly slowed a safety review of the drug, which can be mailed to states that have restricted abortion. Whoever succeeds him will inherit both that review and the political complications surrounding it.
Staff morale at the FDA had fallen sharply following layoffs and the departure of career scientists, including longtime cancer regulator Dr. Richard Pazdur, who cited Makary's leadership as his reason for leaving.
The senior administration official said no single issue drove the decision, describing it instead as a buildup of many problems, with abortion being one of them. Despite the turbulence surrounding recent drug rejections, the pharmaceutical industry is watching the transition carefully, in part because it is currently negotiating the reauthorization of the Prescription Drug User Fee Act, which governs the fees drugmakers pay to fund FDA reviews.
