Marty Makary is leaving the FDA amid growing complaints, including from Trump allies
The head of the US Food and Drug Administration (FDA), Dr. Marty Makary, resigned after a struggle that drew months of complaints from health industry executives, anti-abortion activists, the vaping lobby and other allies of US President Donald Trump.
News of Makary's departure on Tuesday came 13 months after he was confirmed to lead the powerful regulatory agency.
A surgeon and health researcher, Makary stood out among Republicans as an outspoken critic of COVID-19 health measures during the pandemic, appearing frequently on the Fox News Channel.
But he struggled to manage the FDA and failed to win the trust of its staff after mass layoffs, leadership turmoil and a series of controversies in which the agency's scientific principles appeared to be overridden by political interests, including those of Health Secretary Robert F. Kennedy Jr.
“He's a great doctor, and he's had some difficulties,” Trump told reporters outside the White House. “But he's going to keep going and he's going to do well.”
Trump later confirmed on social media that Kyle Diamantas, the agency's chief food officer, is expected to take over as acting commissioner. Diamantas is a lawyer with a personal relationship with Donald Trump Jr.
In that document, the president included what appeared to be a message from Makary submitting a letter of resignation. In it, he noted that “I announced 50 major changes to the FDA. Joe Biden's FDA did not have it,” and thanked Trump for the opportunity to serve.
A work that combines science and politics
The FDA commissioner, as the leader of an agency that regulates billions of dollars in consumer goods and drugs, is often required to juggle competing scientific and political priorities.
Makary faced the unique challenge of balancing calls from Trump and other Republicans to cut red tape at the FDA, while also facing Kennedy's interest in scrutinizing the safety of vaccines, drugs and dietary supplements. The decision to fire Makary was made by Kennedy, and then the White House signed off on it, according to an administration official who was not named because they were not authorized to disclose internal powers.
Almost all of the FDA's top officials resigned, retired or were fired in the first year of Trump's second term, leading to continued leaks and negative media reports documenting low morale, inefficiency and frustration among employees.
Makary's hand-picked deputy, Dr. Vinay Prasad, was fired twice from the agency in less than a year due to competition from specialty drugmakers and rare disease patient groups. Makary appeared ready to face the controversy, despite an ongoing pressure campaign calling for Trump to fire him.
Recent weeks have brought fresh criticism from some interest groups that the White House considers critical to Republican chances in the November election.
Anti-abortion groups accused Makary of moving too slowly in an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target of conservative activists. They want to roll back FDA regulations that allow the pill to be mailed.
“We look forward to the new FDA commissioner ending the mail order abortion drug program,” said Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America.
Vaping executives told Trump that Makary was blocking the approval of their products, including a new flavored e-cigarette seen as vital to the industry's survival.
Last week, the agency abruptly reversed course, approving the first flavored electronic cigarettes and issuing guidelines that freed up marketing from major manufacturers. But it wasn't enough to keep Makary on the job.
A permanent replacement for the FDA job would need to be nominated by Trump and confirmed by the Senate.
It wants to simplify the review of drugs
As a former Fox News regular, Makary was aggressive about promoting his accomplishments on cable television and podcasts and in online opinion pieces.
Earlier this month, US Health and Human Services Secretary Robert F. Kennedy Jr. announced thousands of job cuts at the CDC, FDA and National Institutes of Health. Yukon doctors now say these cuts leave the area vulnerable.
A series of measures from Makary aimed at speeding up or simplifying the FDA's drug reviews, including lowering certain research requirements, integrating AI into drug testing and providing faster reviews for drugs that support “national interests.”
But drug regulators rely on the predictability and consistency of FDA decisions, even more than a quick review. Makary's efforts at drug reform were overshadowed by internal disputes and conflicts that caused headaches for drug makers, investors and patients.
More than a dozen drugmakers studying treatments for rare or difficult-to-treat diseases said they received rejection letters or requests to conduct additional studies on drugs previously approved by FDA officials. Those drugs were largely overseen by Prasad, who resigned for a second time as the FDA's vaccine and biotech chief in April.
The vaccine movement has been criticized
Prasad also dismissed vaccine workers to limit the suitability of the new coronavirus vaccine. In February, Prasad initially refused to even consider Moderna's mRNA flu shot. The FDA was forced to backtrack after Moderna promised to formally challenge the decision and asked the White House to intervene.
Some of Makary and Prasad's more controversial vaccine proposals never materialized, despite creating confusion and concern within the FDA and beyond.
In an internal memo in November, Prasad said — without publishing evidence — that the FDA had linked the vaccine to COVID-19 and the deaths of 10 children. Prasad used that to explain a planned overhaul of the agency's policy approval process.
A dozen former FDA commissioners have blasted the plan, warning it would “undermine the public interest” and derail vaccine development. The FDA has not yet released its mortality analysis or its vaccine reformulation plan.
