WASHINGTON — U.S. FDA Commissioner Marty Makary resigned, President Donald Trump said Tuesday, after weeks of clashing with top White House and health advisers and drawing scrutiny for a series of controversial agency decisions, according to several people familiar with internal dynamics.
Food and Drug Administration Deputy Commissioner for Food Kyle Diamantas will lead the agency in an acting capacity, according to two sources familiar with the situation. Politico first reported the development.
"Marty is a terrific guy, but he's going to go on and he's going to lead a good life. He was having some difficulty," Trump told reporters. "The assistant, the deputy is taking over temporarily until we find someone."
Makary's departure follows weeks of intensifying pressure from powerful Republicans, anti-abortion groups and the Wall Street Journal editorial board, all while he clashed with top officials at the White House and Department of Health and Human Services, according to multiple sources.
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On Friday, Reuters and other outlets reported that Trump signed off on a plan to fire him. Trump rebuked Makary this month for not moving quickly to approve flavored vapes and nicotine products, two people familiar with the conversation said. The FDA approved them days later.
A source familiar with Makary's thinking said that was what drove him to resign.
"It really came down to the fruit-flavored vapes issue," the source said. "He is at peace with the decision. He is a principled guy, didn't want to sign off on something he doesn't believe in."
The White House has not yet found someone to replace Makary on a permanent basis, according to three of the sources. That, in large part, delayed White House plans to fire Makary on Friday, they said.
Makary's exit simultaneously leaves the United States without a permanent head of the FDA or Centers for Disease Control and Prevention, and leaders at other public health agencies.
Mounting pressure on Makary
Makary was criticized for actions including his handling of reintroducing flavored vapes into the U.S. market, a stalled abortion-pill review and public disagreements with drugmakers over reviews of potentially lifesaving medicines and vaccines.
The Journal's editorial page featured at least half a dozen op-eds blasting Makary for controversial drug rejections, including most recently of a cancer drug from Replimune, and calling for his ouster.
The U.S. Senate confirmed Makary, a Johns Hopkins University School of Medicine surgical oncologist who criticized vaccine mandates during the COVID-19 pandemic, as FDA commissioner in March 2025.
He oversaw a sharply smaller agency as thousands of employees were forced out. The FDA had five different vaccine chiefs in the span of a year, including one who was fired, hired back a month later, then left again less than a year after that.
A growing number of top Trump advisers grew frustrated with Makary's tumultuous tenure at the agency, the public criticism and negative news cycles about its decision-making under his leadership, and several advisers clashed with him personally, said the people familiar with internal dynamics.
Searching for a candidate
The White House exerted more control over the health agency in recent months and sought more conventional candidates for top health jobs that require Senate confirmation.
Among those under consideration are former FDA Commissioner Steve Hahn and former acting commissioner and Assistant Health Secretary Brett Giroir, according to three sources.
Finding such candidates often proved difficult, including in the search for an FDA chief. Many are wary of working under Health Secretary Robert F. Kennedy Jr., who espoused views, particularly on vaccines, that contradict scientific evidence. They also would be leading the agency after the staffing cuts and departures, the people said.
Trump allies, supporters of Kennedy's Make America Health Again movement, conservative media, pharmaceutical companies and anti-abortion groups all took public shots at Makary over the past few weeks.
One of the Wall Street Journal op-ed pieces asked whether any administration official created more headaches for Trump than Makary, pointing to the FDA's two rejections of Replimune's melanoma therapy.
Flavored vapes controversy
Makary's handling of flavored e-cigarettes drew Trump's ire as the president pledged to protect the product during his 2024 campaign.
U.S. regulators avoided granting licenses to vapes due to concern over their youth appeal with fruit and candy flavors, and demanded evidence that the products could help smokers quit.
A few days after authorizing the first fruit-flavored e-cigarettes in the United States, the FDA said it would ease its crackdown on some unauthorized vapes under review.
Tobacco companies lobbied Trump and administration officials for changes including a faster, clearer FDA authorization process for the products.
Abortion and drugmaker clashes
Makary repeatedly clashed with drugmakers, in several cases reversing course on product decisions only after companies such as Moderna and Sarepta pushed back publicly.
Some decisions under Makary "didn't really seem to be based on anything that was in line with standard scientific practices. And so it really was just unpredictable," said one pharmaceutical executive, who asked not to be identified as they were not authorized to speak.
"The process of making medicines takes such a long time, and it's so time and money intensive, that consistency and predictability is everything in our industry," the executive added.
Some Republicans and anti-abortion groups also accused Makary of slow-walking a promised abortion pill safety review.
