FDA Commissioner Makary Is Resigning, Sources Say

U.S. Food and Drug Commissioner Marty Makary plans to resign on Tuesday, according to two sources familiar with the situation, the latest leadership change at the federal health department which comes after weeks of public speculation and a mounting pressure campaign.

FDA Deputy Commissioner for Food Kyle Diamantas will lead the agency in an acting capacity, the sources said. Politico first reported the development.

The White House, the FDA and Makary did not immediately respond to requests for comments.

Makary’s planned departure follows weeks of intensifying pressure from powerful Republicans, anti-abortion groups, and the Wall Street Journal editorial board.

On Friday, Reuters and other outlets reported that President Donald Trump had signed off on a plan to fire him.

The White House has not yet found someone to replace Makary on a permanent basis, according to the two people and a third person familiar with internal discussions. That, in large part, had delayed the White House’s plans to fire Makary on Friday, the three people said.

Makary Criticized

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 has 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.

Makary, a Johns Hopkins University School of Medicine surgical oncologist who criticized vaccine mandates during the COVID-19 pandemic, was confirmed by U.S. Congress as FDA commissioner last March.

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.

High Profile Disputes

Trump allies, supporters of Health Secretary Robert F. Kennedy Jr.’s Make America Health Again movement, conservative media, pharmaceutical companies, and anti-abortion groups have all taken public shots at Makary over the past few weeks.

One of the Wall Street Journal op-ed pieces asked whether any administration official had created more headaches for Trump than Makary, pointing to the FDA’s twice-repeated rejection of Replimune’s melanoma therapy.

His tenure included a series of high-profile disputes ​over product reviews for vaccines, gene therapies and other rare-disease drugs. Replimune, after its drug’s second rejection, accused the FDA of contradicting positions the agency had expressed at a meeting in September.

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(Reporting by Yasmeen Abutaleb, Gram Slattery, Daphne Psaledakis and Bhargav Acharya; Editing by Caitlin Webber and Bill Berkrot)

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