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 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.
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