Trump's FDA chief is out after angering pharma CEOs, vaping lobbyists
and anti-abortion activists
[May 13, 2026]
By MATTHEW PERRONE and SEUNG MIN KIM
WASHINGTON (AP) — The head of the Food and Drug Administration, Dr.
Marty Makary, is resigning after a rocky tenure that drew months of
complaints from health industry executives, anti-abortion activists,
vaping lobbyists and other allies of President Donald Trump.
News of Makary's departure Tuesday came just 13 months after he was
confirmed to lead the powerful regulatory agency.
A surgeon and health researcher, Makary came to prominence among
Republicans as an outspoken critic of public health measures during the
COVID-19 pandemic, when he frequently appeared on Fox News Channel. But
he struggled to manage the FDA’s bureaucracy and failed to win the
confidence of its staff after mass layoffs, leadership upheavals 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 was having some difficulty,” Trump told
reporters outside the White House. “But he’s going to go on and he’s
going to do well.”
Trump later confirmed in a social media post that Kyle Diamantas, the
agency’s chief for foods, is expected to take over as acting
commissioner. Diamantas is an attorney with personal ties to Donald
Trump Jr.
In that post, the president included what appeared to be a text message
from Makary submitting his resignation. In it, he noted: “I announced 50
major FDA reforms. Joe Biden's FDA had none.” He thanked Trump for the
chance to serve.
The FDA commissioner, as the leader of an agency that regulates billions
of dollars in consumer goods and medicines, is often required to juggle
competing priorities that straddle science and politics.
Makary faced a unique challenge in balancing calls by Trump and other
Republicans to cut red tape at the FDA, while also tending to Kennedy’s
interest in scrutinizing the safety of vaccines, drugs and food
additives. The decision to get rid of Makary was made by Kennedy, and
then the White House signed off on it, according to an administration
official who was granted anonymity because they were not authorized to
describe internal dynamics.
Virtually all of the FDA’s senior career officials resigned, retired or
were forced out in the first year of the second-term Trump
administration, leading to a steady stream of leaks and negative stories
in the media cataloging low morale, dysfunction and frustration among
staff.
Makary’s handpicked deputy, Dr. Vinay Prasad, was pushed out of the
agency twice in less than a year for running afoul of specialty
drugmakers and groups for patients with rare diseases. Makary appeared
poised to weather the controversy, despite an ongoing pressure campaign
calling on Trump to fire him.
Recent weeks brought fresh criticisms from other interest groups that
the White House considers key to Republican chances in November
elections.
Anti-abortion groups have accused Makary of slow-walking an internal
review of the abortion pill mifepristone, which has been on the market
for 25 years but remains a target for conservative activists. They are
seeking to roll back FDA rules that currently allow the pill to be sent
through the mail.
“We look forward to a new FDA commissioner who will put an end to the
mail-order abortion drug regime,” said Marjorie Dannenfelser, president
of Susan B. Anthony Pro-Life America.
Vaping executives told Trump that Makary was blocking approval of their
products, including new flavored e-cigarettes seen as crucial to the
industry's survival.
Last week, the agency abruptly changed course, authorizing the first
fruit-flavored e-cigarettes and issuing guidelines that loosened
marketing for major manufacturers. But it wasn't enough to keep Makary
in the job.
A permanent replacement for the FDA job will need to be nominated by
Trump and confirmed by the Senate.
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|
 Faster drug reviews are
overshadowed
As a former regular on Fox News, Makary was aggressive about
promoting his accomplishments on cable television and podcasts and
in online opinion pieces.
A string of initiatives from Makary aimed to speed up or streamline
FDA drug reviews, including dropping certain study requirements,
incorporating artificial intelligence into drug evaluations and
offering expedited reviews to medicines that support “national
interests.”
But pharmaceutical executives rely on the predictability and
consistency of FDA decisions, even more than speedy reviews.
Makary’s efforts on drug reviews were overshadowed by internal
conflicts and disputes that created headaches for drugmakers,
investors and patients.
More than a half-dozen drugmakers studying therapies for rare or
hard-to-treat diseases said they received rejection letters or
requests to run additional studies for drugs that had previously
been given the go-ahead by FDA staff. Those drugs were primarily
overseen by Prasad, who stepped down for a second time from his role
as the FDA’s vaccine and biotech chief in April.
Vaccine moves denounced
Prasad repeatedly overruled vaccine staffers to restrict eligibility
for new coronavirus shots. In February, Prasad initially refused to
even consider Moderna’s mRNA shot for flu. The FDA was forced to
reverse itself after Moderna pledged to formally challenge the
decision and called for intervention by the White House.
Some of Makary and Prasad’s most controversial vaccine proposals
never came to fruition, despite stoking confusion and anxiety within
the FDA and beyond.
In an internal memo in November, Prasad claimed — without publishing
evidence — that the FDA had linked COVID-19 shots to the deaths of
10 children. Prasad used that to justify a planned overhaul of the
agency’s approach to approving vaccines.
A dozen former FDA commissioners issued a scathing denunciation of
the plan, warning it would “undermine the public interest” and
decimate vaccine development. The FDA has not released its analysis
of the deaths or its plan for the vaccine overhaul.
FDA's drug center had a revolving door
In the FDA’s drug center, which is the agency's largest division,
Makary oversaw a revolving door of leadership changes. Six people
served as director over the course of one year.
Makary’s initial pick for the job, Dr. George Tidmarsh, was forced
to resign after allegations that he used his FDA position to pursue
a personal vendetta against a former business partner.
His replacement, longtime FDA cancer specialist Dr. Rick Pazdur,
announced he would retire after just three weeks on the job, after
clashing with Makary on multiple issues surrounding drug reviews.
With Makary's departure, the fate of many of his fledgling
initiatives is uncertain.
Most of the programs Makary introduced have not gone through federal
rulemaking required to enshrine them in U.S. law. Democrats in
Congress have questioned the legality of some of those efforts,
including a program that offers drugmakers expedited reviews for
innovative medicines.
___
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