A senior Food and Drug Administration official who oversaw safety reviews of COVID-19 vaccines, antidepressants and other medications has been dismissed from her position directing the agency’s drug program.
Dr. Tracy Beth Hoeg will be succeeded by Dr. Mike Davis, who currently serves as deputy director, according to an internal email to agency personnel on Friday that was obtained by The Associated Press.
In a social media statement posted Friday evening, Hoeg confirmed she was “fired” from the agency, stating: “I learned so much and leave with no regrets.”
This dismissal represents another change in the continuing leadership upheaval at the influential regulatory body. FDA Commissioner Marty Makary left his position earlier this week, while Dr. Vinay Prasad, who headed the agency’s vaccine and biotech division, departed last month amid sharp criticism from pharmaceutical companies, patients and investors.
The agency simultaneously announced Friday that Karim Mikhail will assume the role of acting director for the vaccines center. Mikhail, who has extensive pharmaceutical industry experience, joined the agency under Makary’s leadership last spring.
Makary’s removal from his leadership position at the FDA came after weeks of criticism from President Donald Trump’s political supporters, including anti-abortion organizations and vaping industry advocates, who expressed dissatisfaction with the agency’s current direction.
Hoeg, who shares close ties with Makary and Health Secretary Robert F. Kennedy Jr., has overseen the FDA’s drug program since December, becoming the most recent official to temporarily fill this role during a period of frequent FDA leadership transitions.
Makary orchestrated Hoeg’s swift advancement within the agency, elevating her from her role as his special assistant to head the agency’s most significant center, which oversees regulation of most prescription and over-the-counter medications in the United States.
Typically, FDA center directors are career agency scientists with extensive experience spanning decades. Hoeg lacked prior government service or management background.
Following her arrival at the FDA last March, Hoeg directed safety investigations into injectable RSV medications for children, antidepressants and COVID-19 vaccines.
These investigations aligned with Hoeg’s established interests and concerns from her time before entering government service.
As a sports medicine physician and public health researcher, Hoeg became prominent during the pandemic for criticizing masking requirements, school shutdowns, vaccine mandates and other government policies. She collaborated on research papers with other medical contrarians who later joined the Trump administration, including Makary and Prasad.
Similar to Makary and Prasad, Hoeg regularly shared her views through blog posts and podcasts, including one called “Vaccine Curious.” The podcast explored various debunked theories, including claims that mRNA vaccines might contain dangerous DNA contaminants.
As a Danish American citizen, Hoeg played a key role in the Trump administration’s recent initiative to eliminate several federally recommended childhood vaccinations, including flu shots and hepatitis B vaccines given at birth. A federal judge in Boston has temporarily halted these changes, though the administration intends to challenge the ruling.
During her FDA tenure, Hoeg conducted an “initial analysis” of vaccine injuries that connected COVID-19 shots to 10 reported pediatric deaths — without presenting supporting documentation. These conclusions were outlined in an internal memo Prasad distributed to staff last November, though the FDA has not publicly released the findings or detailed their methodology.
FDA and Centers for Disease Control and Prevention officials have previously determined that serious vaccine side effects occur extremely rarely.
Most recently, Hoeg participated in the agency’s examination of a formal request to add prominent new warnings to antidepressant medications regarding unsubstantiated pregnancy risks, including fetal abnormalities potentially linked to autism and other conditions.
In March, she tried to recruit the petition’s author as a senior adviser at the FDA, according to individuals with knowledge of the situation. This action concerned some agency personnel because Hoeg had repeatedly described this person as a friend, according to sources who spoke to the AP anonymously to discuss confidential FDA business.
