WASHINGTON — The Food and Drug Administration removed Dr. Tracy Beth Hoeg from her role leading the agency's drug program, replacing her with Dr. Mike Davis as acting director. Davis had been serving as deputy director of the FDA's drug center.

Hoeg had led the drug program since December, overseeing the agency's largest center for prescription and over-the-counter drugs. "I learned so much and leave with no regrets," Hoeg said in a podcast interview.

The leadership change followed the resignation of Marty Makary as FDA Commissioner earlier in the week. Dr. Vinay Prasad stepped down last month as the agency's vaccine and biotech chief, and Karim Mikhail, a longtime pharmaceutical executive hired by Makary last spring, will take over as acting director of the FDA's vaccines center. In the weeks before Makary's departure, President Donald Trump's political allies, including anti-abortion groups and vaping lobbyists, complained about the direction of the agency.

Hoeg joined the FDA in March of last year and was promoted by Makary from his special assistant to acting director of the drug center. FDA center directors are typically career agency scientists with decades of experience. Hoeg, a Danish American citizen, had no previous government or management experience. During the COVID-19 pandemic, she publicly criticized masking, school closures, vaccine mandates and other government measures, co-wrote papers with Makary and Prasad, and frequently expressed her opinions in blog posts and podcasts.

Since arriving at the agency, she led investigations into the safety of injectable RSV drugs for children, antidepressants, and COVID-19 vaccines. She also led an initial analysis of vaccine injuries that linked COVID-19 shots to ten reported deaths in children without providing supporting evidence. Prasad sent an internal memo to FDA staffers last November discussing those findings. The agency has not formally announced the findings or explained how they were developed.

Hoeg was involved in the FDA's review of a petition to add warnings to antidepressant drugs about possible pregnancy risks, including fetal abnormalities that could lead to autism and other disorders. In March, she attempted to hire the author of the petition as a senior adviser at the agency. Some FDA staff raised concerns because Hoeg had repeatedly referred to the petition's author as a friend.

Hoeg was also involved in the Trump administration's effort to drop federally recommended childhood vaccines for flu and hepatitis B at birth. A federal judge in Boston temporarily blocked those changes, and the administration plans to appeal.