FDA removes Tracy Beth Hoeg as acting drug center director

FDA removed acting drug center director Tracy Beth Hoeg from her role and replaced her with deputy director Mike Davis, the U.S. Food and Drug Administration confirmed to staff in an email obtained by The Associated Press. Hoeg, who had been leading the agency’s drug program, said in a social media post late Friday that she was “fired,” adding that she “learned so much and leave[s] with no regrets.”

Hoeg’s departure came as the FDA continues to undergo senior leadership turnover. The Associated Press reported that FDA Commissioner Marty Makary resigned earlier in the week, and that Dr. Vinay Prasad stepped down last month after intense criticism from drugmakers, patients and investors. The latest changes also included a leadership swap for the vaccines center, where the FDA announced Karim Mikhail would take over as acting director.

According to the Associated Press, Hoeg will be replaced as acting drug center director by Davis, who had been serving as deputy director. The Associated Press said the email to agency staff reporting the change was sent Friday. In her post, Hoeg described the move as a firing.

The Associated Press linked Makary’s resignation and the broader shake-up at the FDA to weeks of complaints from President Donald Trump’s political allies, including anti-abortion groups and vaping lobbyists, who were frustrated with the direction of the agency. The Associated Press also said Hoeg was closely aligned with Makary and with Health Secretary Robert F. Kennedy Jr.

Hoeg had led the FDA’s drug program since December, the Associated Press said, and the role had been filled briefly by other officials amid what it described as a revolving door of FDA leadership changes. The Associated Press reported that Hoeg’s rapid rise through the agency was engineered by Makary, who 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.

The Associated Press said FDA center directors are typically career agency scientists with decades of experience, but that Hoeg had not previously held government or management experience. It also reported that since arriving at the FDA last March, Hoeg led investigations into the safety of injectable RSV drugs for children, antidepressants, and COVID-19 vaccinations.

The Associated Press described Hoeg as a sports medicine physician and public health scientist who gained attention during the pandemic as a critic of masking, school closures, vaccine mandates and other government measures. The Associated Press said she had co-written papers with other medical contrarians who later joined the Trump administration, including Makary and Prasad. The Associated Press reported that Hoeg also expressed her views in blog posts and podcasts, including one titled “Vaccine Curious,” which it said discussed ideas that critics have characterized as discredited, including claims that mRNA vaccines may contain harmful DNA contaminants.

The Associated Press also reported that Hoeg helped lead efforts tied to the Trump administration to drop federally recommended shots for children, including flu and hepatitis B shots at birth. The Associated Press said those changes were temporarily blocked by a federal judge in Boston and that the administration planned to appeal.

At the FDA, the Associated Press said Hoeg led an “initial analysis” of vaccine injuries that linked COVID-19 shots to 10 reported deaths in children without providing what the story described as supporting evidence. The Associated Press said those findings were discussed in an internal memo that Prasad sent to staffers last November, though it reported that the FDA had not formally announced the findings or explained how they were developed. The Associated Press also said that FDA and the Centers for Disease Control and Prevention had previously concluded that serious side effects from the vaccines are extremely rare.

More recently, the Associated Press said Hoeg was involved in the agency’s review of a petition seeking new warnings for antidepressant drugs about unproven pregnancy risks, including claims about fetal abnormalities that could lead to autism and other disorders. The Associated Press further reported that in March, Hoeg attempted to hire the author of the petition to serve as a senior adviser at the FDA, and that agency staff raised concerns because Hoeg had repeatedly referred to the person as a friend, according to people familiar with the matter who spoke to the AP on the condition of anonymity to discuss confidential FDA matters.