LEILA FADEL, HOST:
The commissioner of the Food and Drug Administration has resigned. Dr. Marty Makary told President Trump he was leaving Tuesday after 13 tumultuous months on the job. In a few minutes, we'll hear from a head of the FDA in Trump's first term about Makary's tenure. First, the details.
MICHEL MARTIN, HOST:
NPR pharmaceuticals correspondent Sydney Lupkin is here to talk about the change. Good morning, Sydney.
SYDNEY LUPKIN, BYLINE: Good morning.
MARTIN: So why is this happening?
LUPKIN: Well, I'm told the final straw for Makary was White House pressure to OK flavored vapes, something he did not agree with. That's according to a federal health official familiar with management of the agency but who wasn't authorized to speak publicly. The pressure has been building for a while. He had survived a series of controversies. Makary was definitely disrupting the agency, which is really in line with what the rest of the Trump administration has been trying to do to the federal government, and he made a lot of people mad. At times, Makary angered the Make America Healthy Again movement for not pushing the MAHA agenda fast enough or hard enough, and he upset people wanting a more predictable approach to regulation at the FDA.
MARTIN: Can you give us some examples?
LUPKIN: Oh, sure. For example, people who support the MAHA movement were upset when the agency approved updated COVID-19 vaccines last year. He also disappointed people who oppose abortion by approving a second generic version of mifepristone. Drugmakers and patient groups who want a consistent and predictable FDA were unhappy with the agency's reversals on experimental drugs and vaccines. Makary made some policy changes without convening the typical FDA advisory committees of outside experts. These committees have a lot of rules around them to make sure they're not biased, and they're typically convened before big agency decisions. It's a way to build public trust. And Makary didn't do that before changing the safety warnings on hormone replacement therapies. At the time, he called the committees bureaucratic, conflicted and expensive. So even though medical groups had long wanted those safety labels changed, they didn't like the way Makary did it.
MARTIN: So what are people saying now that Makary is out?
LUPKIN: In a post on Truth Social, President Trump thanked Makary for doing a great job. But Dr. Ben Rome, a physician and health policy researcher at Brigham and Women's Hospital in Boston, says he's glad to see Makary go.
BEN ROME: I think the last year has been an unmitigated disaster for the FDA. So there has been a lot of changes to regulatory processes that have totally undermined the FDA's independent abilities and have introduced political interference into the process.
LUPKIN: There's also been a big exodus of career staff. That's in addition to the mass firings that took place just after Makary was confirmed last year. Rome says he hopes the next person will right the ship, but he's worried.
MARTIN: So speaking of that, who is the next person that we think will lead the FDA?
LUPKIN: That would be Kyle Diamantas. Trump announced that he'll be the acting commissioner. Diamantas had been the deputy commissioner for food, overseeing nutrition and human food safety. He's a lawyer, not a medical doctor. But the administration has struggled to get some of its health picks confirmed by the Senate, so it may be a while before there's a permanent commissioner.
MARTIN: That is NPR's pharmaceuticals correspondent Sydney Lupkin. Sydney, thank you.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.
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