WASHINGTON (AP) — A U.S. Food and Drug Administration (FDA) official involved in reviewing the safety of antidepressants, COVID-19 vaccines and other widely used treatments has been removed from his role leading the agency’s drug program.
Dr. Tracy Beth Hoeg will serve as acting director of the FDA’s drug center, succeeding Dr. Mike Davis, who has been deputy director, according to an email sent to FDA drug center staff on Friday and obtained by The Associated Press.
Hogg posted on social media late Friday that she was “fired” from the agency, adding: “I learned a lot and leave with no regrets.”
Hogg’s departure is the latest in an ongoing shakeup at the powerful regulator. FDA Commissioner Marty Makary resigned earlier this week, and the agency’s vaccines and biotech chief Dr. Vinay Prasad resigned last month after intense criticism from drugmakers, patients and investors.
The agency also announced Friday that Karim Mikhail will take over as acting director of the vaccine center. Mikhail, a longtime pharmaceutical executive, was hired by Makari last spring.
Makary was ousted from the FDA job after political allies of President Donald Trump, including anti-abortion groups and e-cigarette lobbyists, became frustrated with the agency’s direction.
Hogg, who is close to Macari and Health Secretary Robert F. Kennedy Jr. and has led the FDA’s drug program since December, is the latest official to briefly hold the position in a revolving door of FDA leadership changes.
Hogg’s meteoric rise at the agency was orchestrated by Makary, who quickly promoted her from special assistant to overseeing the agency’s largest center, which oversees most U.S. prescription and over-the-counter drugs.
FDA center directors are typically career agency scientists with decades of experience. Hogg had no previous government or management experience.
Since arriving at the FDA last March, Hoeg has led investigations into the safety of injectable RSV drugs, antidepressants and COVID-19 vaccinations in children.
The investigations reflect Hogg’s long-standing interests and concerns before he joined the government.
Hogg, a sports medicine doctor and public health scientist, first gained attention during the pandemic for his criticism of mask-wearing, school closures, vaccine mandates and other government measures. She co-authored the paper with other medical contrarians who later joined the Trump administration, including Makari and Prasad.
Like Makkari and Prasad, Hogg frequently expresses his views in blog posts and podcasts, including one titled “Vaccine Curiosity.” The podcast discusses a number of discredited ideas, including that mRNA vaccines may contain harmful DNA contaminants.
Hogg, a Danish-American citizen, was instrumental in the Trump administration’s recent efforts to roll back federally recommended childhood vaccinations, including flu and hepatitis B vaccines at birth. The changes have been temporarily blocked by a federal judge in Boston, but the government plans to appeal the decision.
At the FDA, Hoeg led a “preliminary analysis” of vaccine injury that linked the COVID-19 shot to 10 reported deaths in children but provided no supporting evidence. The findings were discussed in an internal memo Prasad sent to employees in November, but the FDA has yet to formally announce them or explain how they were developed.
Officials at the FDA and Centers for Disease Control and Prevention have previously concluded that serious side effects from the vaccine are extremely rare.
Most recently, Hogg was involved in the agency’s review of a formal petition to add bold new warnings to antidepressants about unproven pregnancy risks, including fetal malformations that could lead to autism and other conditions.
In March, she tried to hire the petition’s author as a senior adviser to the FDA, according to people familiar with the matter. The incident caused concern among some agency staff because Hogg repeatedly called the man a friend, according to an AP source who spoke on condition of anonymity.
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