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

The U.S. Food and Drug Administration (FDA) announced Friday that Dr. Tracy Beth Hoeg will leave her role as acting director of the drug center, effective immediately. Hoeg, who led investigations into COVID-19 vaccines, antidepressants, and RSV drugs for children, will be replaced by Dr. Mike Davis, the current deputy director. Hoeg’s departure marks the latest in a series of leadership changes at the FDA, following Commissioner Marty Makary’s resignation earlier this week and the stepdown of vaccine and biotech chief Dr. Vinay Prasad last month. Both Makary and Prasad faced intense criticism from drugmakers, patients, and political allies of former President Donald Trump, including anti-abortion groups and vaping lobbyists. Hoeg’s tenure as drug center director began in December 2023, after Makary rapidly promoted her from special assistant to oversee the agency’s largest center, responsible for regulating most U.S. prescription and over-the-counter drugs. Unlike typical FDA center directors—who are often career scientists with decades of experience—Hoeg had no prior government or management experience before joining the agency in March 2023. Before her government role, Hoeg was a sports medicine physician and public health scientist who publicly criticized pandemic measures like masking, school closures, and vaccine mandates. She co-authored papers with other medical contrarians, including Makary and Prasad, and frequently shared opinions through blog posts and podcasts. The FDA also announced Friday that Karim Mikhail, a longtime pharmaceutical executive hired by Makary last spring, will take over as acting director of the vaccines center. Hoeg responded to her removal on social media, stating she was ‘fired’ and left with ‘no regrets,’ though the agency did not confirm the reason for her departure.