FDA official who scrutinized COVID shots and antidepressants is out in latest shake-up

WASHINGTON (AP) — A Food and Drug Administration official involved in scrutinizing the safety of antidepressants, COVID-19 vaccines and other widely used therapies is stepping down 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’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.

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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