FDA Names Mike Davis Acting Director of Drug Center

Dr. Tracy Beth Hoeg was removed from her role as acting director of the FDA's Center for Drug Evaluation and Research and replaced by Dr. Mike Davis, who had been serving as deputy director. An email sent to FDA agency staff on Friday announced the replacement.

Hoeg posted on social media late Friday that she was “fired” from the agency. She wrote, "I'm incredibly grateful to have had this opportunity to serve this country & proud of the work we did. " The departure marks the latest in an ongoing shake-up at the agency.

FDA Commissioner Marty Makary resigned earlier in the week, and Dr. Vinay Prasad stepped down last month as the agency's vaccine and biotech chief. The agency also announced Friday that Karim Mikhail, a longtime pharmaceutical executive hired by Marty Makary last spring, would take over as acting director of the FDA's vaccines center.

Hoeg had been leading FDA's drug program since December after Marty Makary promoted her from serving as his special assistant to overseeing the agency's largest center. She arrived at the FDA last March with no previous government or management experience.

Since joining the agency, Hoeg led investigations into the safety of injectable RSV drugs for children, antidepressants and COVID-19 vaccinations.

Hoeg was instrumental in the Trump administration’s recent effort to drop federally recommended shots for children including those for the flu and hepatitis B at birth. A federal judge in Boston temporarily blocked changes to federally recommended childhood shots, and the Trump administration plans to appeal the federal judge's decision.

Hoeg led an “initial analysis” of vaccine injuries that linked COVID-19 shots to 10 reported deaths in children.

The findings were discussed in an internal memo Vinay Prasad sent to staffers last November. In March, Hoeg attempted to hire the author of a formal petition to add bold new warnings to antidepressant drugs about pregnancy risks including fetal abnormalities that could lead to autism. She had been involved in the agency’s review of that petition.

Dr. Vinay Prasad departed the agency last month. Hoeg had served as acting director of the FDA's Center for Drug Evaluation and Research since December and co-wrote papers with both Marty Makary and Vinay Prasad before joining the government.