Marty Makary is out as Trump’s FDA chief; acting role goes to Kyle Diamantas

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Dr. Marty Makary, the head of the U.S. Food and Drug Administration, is resigning after a turbulent tenure that drew sustained complaints from multiple groups aligned with President Donald Trump, according to the Associated Press. Makary’s departure comes roughly 13 months after he was confirmed to lead the agency, AP reported.

Trump told reporters outside the White House that he likes Makary and said Makary “was having some difficulty” but “is going to go on and he’s going to do well.” In a separate post on social media, Trump also confirmed that Kyle Diamantas, the FDA’s chief for foods, is expected to take over as acting commissioner.

AP reported that the White House leadership change unfolded against a backdrop of repeated upheaval inside the agency. The report said virtually all of the FDA’s senior career officials resigned, retired or were forced out during the first year of Trump’s second term, fueling leaks and negative coverage describing low morale, dysfunction and frustration among staff.

Makary’s tenure, AP said, was shaped by tensions over how to balance Republican goals to reduce FDA “red tape” with the interests of Health Secretary Robert F. Kennedy Jr. in scrutiny involving vaccines, drugs and food additives. AP reported that the decision to remove Makary was made by Kennedy and then signed off by the White House, citing an administration official who spoke on condition of anonymity because they were not authorized to describe internal dynamics.

Makary’s exit also reflected pressure from interest groups outside the FDA. AP reported that anti-abortion groups accused Makary of slow-walking an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target for conservative activists seeking regulatory changes. AP quoted Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, as saying, “We look forward to a new FDA commissioner who will put an end to the mail-order abortion drug regime.”

In addition, AP reported that vaping industry executives told Trump that Makary was blocking approval of their products, including new flavored e-cigarettes described in the story as important to the industry’s survival. The FDA, AP said, had recently changed course—authorizing the first fruit-flavored e-cigarettes and issuing guidelines that loosened marketing for major manufacturers—but the changes were not enough to keep Makary in the job.

AP also described the leadership and policy disputes that surrounded Makary’s handpicked deputy, Dr. Vinay Prasad, who was pushed out of the agency twice in less than a year for running afoul of specialty drugmakers and groups representing patients with rare diseases. The report said Prasad stepped down from a second time in April from the FDA role overseeing vaccines and biotech, and that Makary appeared positioned to weather the controversy until later criticism intensified.

The AP account said disputes over vaccine decisions were among the most contentious issues associated with the Makary-Prasad era. It reported that Prasad repeatedly overruled vaccine staffers on eligibility for new coronavirus shots, including an episode in February when the FDA initially refused to even consider Moderna’s mRNA shot for flu, before later reversing course after Moderna pledged to challenge the decision and asked for White House intervention.

AP further reported that some proposals tied to Makary and Prasad never came to fruition, while still contributing to internal confusion at the agency. The report said that in an internal memo in November, Prasad claimed—without publishing evidence—that the FDA linked COVID-19 shots to the deaths of 10 children and used that, AP reported, to justify a planned overhaul of the agency’s approach to approving vaccines.

AP said a dozen former FDA commissioners issued a denunciation of that plan, warning it would “undermine the public interest” and decimate vaccine development, and noted that the FDA had not released an analysis of the deaths or its plan for the vaccine overhaul. In the drug-review center, AP reported that Makary oversaw a revolving door of leadership changes, including an initial pick for drug-center director, Dr. George Tidmarsh, who was forced to resign amid allegations of using the FDA position to pursue a personal vendetta, and later Dr. Rick Pazdur, who announced retirement after three weeks.

With Makary’s resignation, AP said uncertainty now surrounds the future of several initiatives he introduced. It reported that most of those programs have not completed federal rulemaking needed to enshrine them in U.S. law, and that Democrats in Congress questioned the legality of some efforts, including a program offering expedited reviews for “innovative medicines.” AP added that a permanent replacement would require nomination by Trump and confirmation by the Senate.