FDA official who scrutinized COVID shots and antidepressants is out in
latest shake-up
[May 16, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — A Food and Drug Administration official involved in
scrutinizing the safety of antidepressants, COVID-19 vaccines and other
widely used therapies has been removed from her role leading the
agency's drug program.
Dr. Tracy Beth Hoeg will be replaced as FDA's acting drug center
director by Dr. Mike Davis, who has been serving as deputy director,
according to an email sent to agency staff Friday that was obtained by
The Associated Press.
Hoeg said in a social media post late Friday that she was “fired,” from
the agency, adding: “I learned so much and leave with no regrets.”
Hoeg's departure is the latest in an ongoing shake-up at the powerful
regulatory agency. FDA Commissioner Marty Makary resigned earlier in the
week, and Dr. Vinay Prasad, the agency's vaccine and biotech chief,
stepped down last month following intense criticism from drugmakers,
patients and investors.
The agency also announced Friday that Karim Mikhail would take over as
acting director of the vaccines center. Mikhail, a longtime
pharmaceutical executive, was hired by Makary last spring.
Makary's ouster from his role atop the FDA followed weeks of complaints
from President Donald Trump's political allies, including anti-abortion
groups and vaping lobbyists, who are frustrated with the direction of
the agency.
Hoeg, who is closely aligned with Makary and Health Secretary Robert F.
Kennedy Jr., had been leading FDA's drug program since December, the
latest official to briefly hold that position amid a revolving door of
FDA leadership changes.
Hoeg's rapid rise through the agency was engineered by Makary, who
quickly promoted her from serving as his special assistant to overseeing
the agency's largest center, responsible for regulating most U.S.
prescription and over-the-counter drugs.
FDA center directors are typically career agency scientists with decades
of experience. Hoeg had no previous government or management experience.
Since arriving at the FDA last March, Hoeg led investigations into the
safety of injectable RSV drugs for children, antidepressants and
COVID-19 vaccinations.
Those inquiries reflected Hoeg’s longstanding interests and concerns
from before joining government.
A sports medicine physician and public health scientist, Hoeg first
gained attention during the pandemic as a critic of masking, school
closures, vaccine mandates and other government measures. She co-wrote
papers with other medical contrarians who would go on to join the Trump
administration, including Makary and Prasad.
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Dr. Tracy Beth Hoeg, with the FDA, listens during a meeting of the
Advisory Committee in Immunization Practices at the CDC, June 25,
2025, in Atlanta. (AP Photo/Mike Stewart, File)
 Like Makary and Prasad, Hoeg also
frequently expressed her opinions in blog posts and podcasts,
including one titled “Vaccine Curious.” The podcast discussed a
number of discredited ideas, including that mRNA vaccines may
contain harmful DNA contaminants.
A Danish American citizen, Hoeg was instrumental in the Trump
administration’s recent effort to drop a number of federally
recommended shots for children, including those for the flu and
hepatitis B at birth. Those changes have been temporarily blocked by
a federal judge in Boston, though the administration plans to appeal
the decision.
At the FDA, Hoeg led an “initial analysis” of vaccine injuries that
linked COVID-19 shots to 10 reported deaths in children — without
providing the supporting evidence. The findings were discussed in an
internal memo Prasad sent to staffers last November, though the FDA
has not formally announced the findings or explained how they were
developed.
Officials from the FDA and the Centers for Disease Control and
Prevention have previously concluded that serious side effects from
the vaccines are extremely rare.
More recently, Hoeg was involved in the agency’s review of a formal
petition to add bold new warnings to antidepressant drugs about
unproven pregnancy risks, including fetal abnormalities that could
lead to autism and other disorders.
In March, she attempted to hire the author of the petition to serve
as a senior adviser at the FDA, according to people familiar with
the situation. The matter raised concerns among some agency staff
because Hoeg had repeatedly referred to the person as a friend,
according to the people who spoke to the AP on the condition of
anonymity to discuss confidential FDA matters.
___
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