WASHINGTON – A significant change has occurred at the Food and Drug Administration (FDA) as Dr. Tracy Beth Hoeg was removed from her position leading the agency’s drug program. This decision comes amid a broader shake-up at the FDA, which has seen several high-profile departures recently.
Dr. Hoeg was known for her critical role in evaluating the safety of various medical treatments, including antidepressants and COVID-19 vaccines. According to an email obtained by The Associated Press, she will be succeeded by Dr. Mike Davis, who has been serving as the deputy director of the FDA’s drug center.
In a social media post, Dr. Hoeg stated that she was “fired” from the agency but expressed gratitude for the experience, saying she left with “no regrets.” Her removal adds to the ongoing turbulence within the FDA, as Commissioner Marty Makary resigned earlier that week, and Dr. Vinay Prasad, the agency’s vaccine and biotech chief, stepped down last month.
Karim Mikhail has been appointed as the acting director of the vaccines center, having been a longtime pharmaceutical executive hired by Makary last spring. The shake-up at the FDA has been influenced by discontent from political allies of former President Donald Trump, including various advocacy groups.
Dr. Hoeg was closely aligned with Makary and Health Secretary Robert F. Kennedy Jr. She had just taken over the FDA’s drug program in December. Her rapid rise within the agency was largely due to Makary’s support, transitioning her from a special assistant to head of the FDA’s largest center, which regulates most prescription and over-the-counter drugs.
Typically, FDA center directors have extensive backgrounds in science and management, but Dr. Hoeg came to the position with limited government experience. Since joining the FDA, she led significant investigations into the safety of injectable drugs for children, antidepressants, and COVID-19 vaccines, reflecting her pre-existing interests in these areas.
Before her FDA role, Dr. Hoeg, a sports medicine physician and public health scientist, gained attention during the COVID-19 pandemic for her controversial views on masking, school closures, and vaccine mandates. She co-authored papers with other critics who later joined the Trump administration.
Dr. Hoeg also hosted a podcast titled “Vaccine Curious,” where she discussed various topics, some of which included debunked theories about mRNA vaccines. Her work influenced recent efforts to alter federal vaccine recommendations for children, although these changes are currently blocked pending legal review.
At the FDA, she conducted an “initial analysis” linking COVID-19 vaccinations to reported deaths in children, though the details of this analysis have not been formally disclosed. The FDA has otherwise stated that serious vaccine side effects are rare.
Recently, Dr. Hoeg was also involved in reviewing a petition for new warnings on antidepressants regarding potential risks during pregnancy, which raised eyebrows among some FDA staff due to her personal connections to the petition’s author.
The ongoing shifts at the FDA underscore the challenges the agency faces in balancing public health concerns with political pressures, especially in a rapidly evolving medical landscape. As these changes unfold, the FDA’s role in drug safety and oversight remains crucial for public health.
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