The Food and Drug Administration's top drug official is leaving in the latest shake-up at the powerful health agency.
FILE - Dr. Tracy Beth Hoeg , with the FDA, listens during a meeting of the Advisory Committee in Immunization Practices at the CDC, June 25, 2025, in Atlanta.
will be replaced as FDA's acting drug center director by Dr. Mike Davis, who has been serving as deputy director, according to an email sent to agency staff Friday that was obtained by The Associated Press. Hoeg said in a social media post late Friday that she was “fired,” from the agency, adding: “I learned so much and leave with no regrets.
”The agency also announced Friday that Karim Mikhail would take over as acting director of the vaccines center. Mikhail, a longtime pharmaceutical executive, was hired by Makary last spring.
Hoeg, who is closely aligned with Makary and Health Secretary Robert F. Kennedy Jr., had been leading FDA's drug program since December, the latest official to briefly hold that position amid a Hoeg's rapid rise through the agency was engineered by Makary, 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. She co-wrote papers with other medical contrarians who would go on to join the Trump administration, including Makary and Prasad. Like Makary and Prasad, Hoeg also frequently expressed her opinions in blog posts and podcasts, including one titled “Vaccine Curious.
” The podcast discussed a number of discredited ideas, including that mRNA vaccines may contain harmful DNA contaminants. 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 Prasad 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, according to the people who spoke to the AP on the condition of anonymity to discuss confidential FDA matters.
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Coronavirus Mike Davis U.S. News Vinay Prasad Robert F. Kennedy Jr. Donald Trump Tracy Beth Hoeg Marty Makary Washington News
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