Trump says US FDA Commissioner Makary is out

By Yasmeen Abutaleb and Ahmed Aboulenein

WASHINGTON, May 12 (Reuters) - U.S. FDA Commissioner Marty Makary resigned, President Donald Trump said on 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, Trump said. 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 resigned effective Tuesday via a text message to Trump, touting his moves to speed up some drug review times, support research into psychedelic drugs and broaden use of menopause hormone therapies.

"It's been the honor of a lifetime to serve as your FDA Commissioner. I am forever grateful," he wrote in the message, which Trump shared on Truth Social.

Makary's departure followed 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.

On Friday, Reuters and other outlets reported that Trump had signed off on a plan to fire him. ​Trump had rebuked Makary earlier 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.

Makary's exit simultaneously leaves the U.S. without permanent heads of the FDA and Centers for Disease Control and Prevention, as well as other top public health posts.

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 has featured at least half a dozen op-eds blasting Makary for controversial drug rejections, including most recently of a cancer drug from Replimune REPL.O, 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 the U.S. Senate 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.

A growing number of top Trump advisers had grown 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 has exerted more control over the health agency in recent months and has 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.

Many who might qualify as candidates are wary of working under Health Secretary Robert F. Kennedy Jr., who has espoused views, particularly on vaccines, that contradict scientific evidence.

Trump allies, supporters of Kennedy's Make America Healthy 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.

The search for a new commissioner has already started, Kennedy said in a post on X in which he thanked Makary and expressed "full confidence" in Diamantas as acting FDA chief.

Diamantas, who has been photographed hunting with the president's eldest son, Donald Trump Jr., is a lawyer with no medical or scientific degrees.

FLAVORED VAPES CONTROVERSY

Makary's handling of flavored e-cigarettes drew Trump's ire, as the president had pledged to protect the product during his 2024 campaign.

U.S. regulators had 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 ​have been lobbying 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 MRNA.O and Sarepta SRPT.O 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 named 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.

He also was accused by some Republicans and anti-abortion groups of slow-walking a promised abortion pill safety review.