Lizzy Lawrence, STAT News, May 12,2026
WASHINGTON — Food and Drug Administration Commissioner Marty Makary is resigning from his role, and Kyle Diamantas, the top food regulator at the agency, will step in as acting commissioner.
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Makary served in the role for a little over a year. Spokespeople for Makary and Health and Human Services Secretary Robert F. Kennedy Jr. didn’t respond to messages seeking comment.
A group within HHS was unhappy with Makary’s leadership and had been looking into ways to remove him for months, FDA sources told STAT.
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Makary’s exit means that the Trump administration needs to fill yet another slot in Kennedy’s health department, which also lacks a permanent Centers for Disease Control and Prevention director and a surgeon general. As with those roles, the appointment of a permanent FDA commissioner requires Senate confirmation.
It also adds to a slew of vacancies atop the FDA. Neither the agency’s drug center nor the biologics center is led by a permanent official.
Makary’s tenure was filled with the announcement of dozens of new and ambitious initiatives, including efforts to shorten drug review timelines, crack down on misleading ads, and pressure the food industry to remove chemical dyes.
But it was also tumultuous, marked by personnel drama, departures of long-time staff, and controversy over political pressure impeding the FDA’s scientific process. His departure comes after months of reports suggesting he was on “thin ice” with his administration bosses. Rumors of his potential firing have spread among industry leaders, lobbyists, and legislative staffers since at least late 2025.
In addition to several high-profile management fumbles, Makary repeatedly found himself facing political conundrums.
Most recently, according to the Wall Street Journal, he tried to block agency scientists from approving flavored vapes and then faced the ire of President Trump, who wanted him to approve them to appease young voters in the Make America Great Again movement. Makary has also angered the anti-abortion community and some Republican lawmakers by slow-walking a safety study on the abortion pill mifepristone.
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The Trump administration last shook up HHS leadership just three months ago, pushing out two top officials in a bid to mitigate dysfunction in Kennedy’s department and focus it on politically popular initiatives such as healthier food.
Before joining the FDA in February 2025 as director of the food center, Diamantas was an attorney in Florida who worked with food and beverage industry clients. He is also a friend and hunting buddy of Donald Trump Jr., the president’s son.
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It’s not clear how long Diamantas will be leading the FDA, but his background makes him an unusual fit for the role. FDA commissioners typically have medical training and experience.
“Kyle Diamantas now has a nearly impossible charge—leading, as a non-scientist, a science-based agency under an unqualified Secretary who puts his own medical and nutritional pet peeves over evidence-based public health,” said Peter Lurie, director of the Center for Science in the Public Interest.
Makary’s tenure
Public health experts and industry leaders were cautiously optimistic when Trump tapped Makary, a Johns Hopkins pancreatic surgeon, for FDA commissioner. He had sterling medical credentials, and presented himself as an independent thinker with a deep respect for science and evidence.
Some were wary of his closeness with health secretary Robert F. Kennedy Jr., a longtime vaccine skeptic known to spread unfounded theories. He entered Kennedy’s orbit after criticizing mainstream prevention measures during the Covid-19 pandemic, including compulsory masking and vaccine requirements for young, healthy people.
Nevertheless, Makary sailed through his Senate confirmation hearing, earning bipartisan support.
But it quickly became apparent that Makary was not able to, or did not prioritize, insulating agency scientists from ideological pressure, a sharp departure from FDA norms.
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Staff noticed a trend of political influence starting to shape scientific decisions, for example when scientists were pressed to approve a drug for autism treatment based on thin evidence. Employees pushed back and narrowed the approval to a rare neurological disorder, but the incident spooked them.
Makary launched a new Commissioner’s National Priority Voucher program rewarding companies that “aligned with national priorities” a one-to-two month drug review. The program gave the White House and top political officials at the agency a way to exert control over which medicines make their way to patients most quickly. Most recently, Sanofi asked to pull out of the program after Høeg, a political appointee, began interfering with the review.
The agency saw massive turnover during his tenure. He entered the agency on an unfortunate day, April 1, 2025, as Kennedy laid off 3,500 FDA employees. Hundreds more have been pushed out or left voluntarily, leaving a gap in institutional knowledge at the agency.
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Reactions from industry, safety advocates
Industry leaders and patient safety experts expressed relief to STAT upon hearing about the possibility of Makary’s departure. Some praised his initiatives and ideas to optimize drug development. But many felt he was ill-suited to the job.
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John Maraganore, former Alnylam Pharma CEO, called the news “an enormous relief.”
“FDA chaos was kryptonite for our industry’s efforts to bring innovation to patients,” he said.
Diana Zuckerman, president of the National Center for Health Research, said the involvement of political officials in the FDA’s decisions have severely damaged trust.
“I think he is the worst FDA Commissioner in the 40 years I’ve been involved in FDA issues,” she said. “He has made it impossible to trust agency decisions.”
Zuckerman said even though she agreed with some of Makary’s comments and initiatives, he often presented issues in an extreme or biased way, convening panels on topics like the potential risks of talc or antidepressants with experts that heavily skewed one way.
“The truth got so mixed in with exaggeration and misinformation that even when he said some things that had validity, it got lost in the extreme comments,” Zuckerman said. “It got lost in the biased way it was presented.”
Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania’s Perelman School of Medicine, said she was excited about the plausible mechanism framework and the release of drug rejection letters. But she said his tenure at the agency was ultimately tarnished by political interference and a failure to manage staff.
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