FDA Official Who Scrutinized COVID Shots and Antidepressants Is Out in Latest Shake-Up

The U.S. Food and Drug Administration's acting drug center director, Dr. Tracy Beth Hoeg, has been removed from her role leading the agency's drug program after spearheading reviews of the safety of antidepressants, COVID-19 vaccines and injectable RSV drugs for children. Hoeg will be replaced by Dr. Mike Davis, who had been serving as deputy director, according to an email sent to agency staff Friday. Hoeg said in a social media post late Friday that she was "fired," adding: "I learned so much and leave with no regrets."

Hoeg's departure is the latest in an ongoing shake-up at the regulatory agency. The FDA commissioner resigned earlier in the week, and 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 a longtime pharmaceutical executive would take over as acting director of the vaccines center. The commissioner's ouster 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 the commissioner and the health secretary, had been leading the FDA's drug program since December. Her rapid rise through the agency was engineered by the commissioner, 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. 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.

In her first address to staff, Hoeg said her top priorities included evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV. "I've been interested to learn we really haven't been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job," Hoeg said. "I actually think that there's agreement about that, and among the CDER staff that I've been working with on this issue, so I'm excited to see that."

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 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.