Dr. Tracy Beth Hoeg, the acting director of the Food and Drug Administration’s drug program who had led a series of investigations into widely used medications including COVID-19 vaccines and antidepressants, was removed from her post on Friday, according to an internal agency email obtained by the Associated Press. Her departure is the latest in a cascade of leadership changes at the FDA that this week also saw the resignation of Commissioner Marty Makary.
Hoeg confirmed the move in a social media post late Friday, saying she was “fired.” “I learned so much and leave with no regrets,” she wrote. She will be replaced as acting director of the Center for Drug Evaluation and Research by Dr. Mike Davis, the center’s deputy director, the email said.
The shake-up extends beyond the drug center. Earlier in the week, Makary stepped down after weeks of complaints from President Donald Trump’s political allies — including anti-abortion groups and vaping lobbyists — who were frustrated with the agency’s direction, according to the AP. Last month, Dr. Vinay Prasad, the agency’s vaccine and biotech chief, resigned amid intense criticism from drugmakers, patients, and investors. On Friday, the FDA also announced that Karim Mikhail, a longtime pharmaceutical executive hired by Makary last spring, would become acting director of the vaccines center.
Hoeg, a sports medicine physician and public health scientist with no prior government or management experience, rose rapidly through the agency after being appointed by Makary. She served first as his special assistant before being promoted in December to oversee the FDA’s largest center, which is responsible for regulating most U.S. prescription and over-the-counter medications — a role typically held by career agency scientists with decades of experience.
Her short tenure was marked by inquiries that reflected her longstanding skepticism of vaccine mandates, masking, and school closures, positions she had advocated before joining government. Hoeg co-wrote papers with Makary and Prasad, both of whom also gained prominence as critics of pandemic-era public health measures. She also hosted a podcast titled “Vaccine Curious,” which discussed ideas that mainstream public health authorities have discredited, including the claim that mRNA vaccines contain harmful DNA contaminants.
At the FDA, Hoeg led what she called an “initial analysis” of vaccine injuries that linked COVID-19 shots to 10 reported deaths in children, according to an internal memo sent by Prasad to agency staff last November. The FDA has not formally released the findings or explained the methodology, and 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 risks to pregnancies, including claims that the drugs could cause fetal abnormalities leading to autism and other disorders. In March, she attempted to hire the author of that petition as a senior adviser at the FDA, according to people familiar with the situation who spoke to the AP on condition of anonymity because they were not authorized to discuss confidential personnel matters. Those people told the AP that Hoeg had repeatedly referred to the petitioner as a friend, raising concerns among agency staff.
Hoeg was also instrumental in the Trump administration’s recent effort to drop a number of federally recommended childhood vaccinations, including those for influenza and the hepatitis B shot given at birth. A federal judge in Boston has temporarily blocked those changes, though the administration plans to appeal.
The removal of Hoeg leaves the FDA’s drug review center under new leadership at a moment of unusual flux for the agency. In addition to the departures of Makary, Prasad, and Hoeg, the agency’s vaccine center is also transitioning to new leadership under Mikhail. The changes follow months of internal friction over the direction of vaccine policy and drug safety under political appointees aligned with Health Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.