WASHINGTON — A Food and Drug Administration official who led reviews of COVID-19 vaccines and antidepressants has been removed from her post overseeing the agency’s drug program, the latest shift in a series of leadership changes at the powerful regulator.
Dr. Tracy Beth Hoeg will be replaced as acting director of the FDA’s Center for Drug Evaluation and Research by Dr. Mike Davis, who had been serving as deputy director. The move was announced in an email to agency staff on Friday, according to reporting by The Associated Press.
Hoeg, in a social media post late Friday, said she had been “fired” from the agency. “I learned so much and leave with no regrets,” she wrote.
The departure comes amid broader turmoil at the FDA. Commissioner Marty Makary resigned earlier in the week, while Dr. Vinay Prasad, who led the agency’s vaccine and biotech efforts, stepped down last month after facing criticism from drugmakers, patients and investors. On Friday the agency also named Karim Mikhail, a longtime pharmaceutical executive hired by Makary last spring, as acting director of the vaccines center.
Hoeg’s rise at the FDA was swift. She joined the agency last March as a special assistant to Makary and was quickly promoted to lead the drug center in December. The center regulates most prescription and over-the-counter drugs in the United States. Unlike many past center directors, who typically have decades of government experience, Hoeg had no prior management or federal service background.
Her work at the agency reflected long-standing interests she held before entering government. A sports medicine physician and public health scientist, Hoeg gained attention during the pandemic as a critic of masking, school closures and vaccine mandates. She co-authored papers with other physicians who later joined the Trump administration, including Makary and Prasad.
Hoeg also hosted a podcast called “Vaccine Curious” that explored topics such as potential DNA contaminants in mRNA vaccines. At the FDA she led an initial analysis linking COVID-19 shots to 10 reported deaths in children, findings discussed in an internal memo from Prasad last November. The agency has not formally released supporting evidence for those conclusions.
Officials at the FDA and the Centers for Disease Control and Prevention have long maintained that serious side effects from the vaccines are extremely rare. Hoeg was also involved in reviewing a petition seeking stronger warnings on antidepressant labels regarding unproven pregnancy risks, including possible links to autism and other disorders.
In March she attempted to hire the author of that petition as a senior adviser, a move that raised concerns among some staff because Hoeg had referred to the individual as a friend, according to people familiar with the matter who spoke to the AP on condition of anonymity.
Hoeg, a Danish American citizen, played a role in recent Trump administration efforts to remove several federally recommended childhood vaccines, including flu and hepatitis B shots given at birth. A federal judge in Boston has temporarily blocked those changes, though the administration plans to appeal.
The shake-up at the FDA follows weeks of complaints from President Donald Trump’s political allies, including anti-abortion groups and vaping lobbyists, who expressed frustration with the agency’s direction under Makary. Health Secretary Robert F. Kennedy Jr. has been closely aligned with several of the departing officials.
Hoeg’s removal leaves the drug center once again under new leadership as the agency continues to navigate regulatory questions around vaccines, antidepressants and other therapies. The revolving door of acting directors has drawn attention to the stability of FDA operations during a period of significant policy shifts.
Agency staff and outside observers are watching to see how the latest appointments will affect ongoing reviews and public health recommendations. Davis, the incoming acting drug center director, has worked within the agency for years and is viewed by some as a more traditional choice for the role.
Broader questions remain about the direction of vaccine policy and drug safety oversight under the current administration. The temporary court order blocking changes to childhood vaccine schedules adds another layer of uncertainty to federal recommendations.