FDA commissioner is set to resign after tumultuous tenure

"“Marty is a great guy. He's a friend of mine. He's a wonderful man, and he's going to be off and the assistant, the deputy, is taking over temporarily,” Trump said. “He was having some difficulty, you know, he's a great doctor, and he was having some difficulty. But he's going to go on and he's going to do well.”"

"“It came down to the fruit-flavored vape issue,” the person with knowledge of the situation said, referring to pressure on Makary from the White House to authorize the sales of flavored e-cigarettes earlier this month. “He is at peace with the decision [to leave]. And he's in good spirits, I would say.”"

"Makary's resignation would end a tumultuous 13-month tenure at the agency. At times he angered the Make America Healthy Again movement galvanized by Health Secretary Robert F. Kennedy Jr., for not advancing its agenda quickly enough. He also upset people looking for a more traditional approach to regulation by the FDA as they knew it before Trump was elected for a second term."

"Makary upset some in the MAHA movement when the agency approved updated mRNA vaccines against COVID-19, and has disappointed those who oppose abortion by approving a second generic version of mifepristone and not completing a promised safety review of the medicine."

Marty Makary is expected to resign as commissioner of the Food and Drug Administration, with the deputy commissioner taking over temporarily. President Trump said Makary would be off and the assistant would lead in the interim, adding that Makary had difficulty but would do well. A federal health official linked the resignation to pressure from the White House over authorization of flavored e-cigarettes earlier in the month. Makary’s 13-month tenure is described as tumultuous, with conflicts involving the Make America Healthy Again movement and expectations for a more traditional FDA regulatory approach. He faced criticism for approving updated mRNA COVID-19 vaccines, approving a second generic version of mifepristone, and not completing a promised safety review. Before joining the administration, he worked as a surgeon and health policy researcher at Johns Hopkins and was critical of vaccine policy during the COVID pandemic.

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