FDA official who scrutinized COVID shots and antidepressants is out in latest shake-up
WASHINGTON (AP) — A Food and Drug Administration Official who studies the safety of antidepressants Covid-19 vaccines And Other commonly used treatments He was relieved of his duties managing the agency’s drug program.
Dr. Tracy Beth Hoeg He was replaced as acting director of the FDA’s drug center by Dr. Mike Davis will get it.
Hoeg said he was “fired” from the agency in a social media post late Friday, adding: “I learned a lot and left with no regrets.”
Hoeg’s departure This is the latest in an ongoing shakeup of the powerful regulatory body. FDA Commissioner Marty Makary He resigned at the beginning of the week and Dr. Vinay PrasadThe agency’s vaccine and biotechnology chief resigned last month following intense criticism from drugmakers, patients and investors.
The agency also announced Friday that Karim Mikhail will take over as acting director of the vaccination centre. Mikhail, a long-time pharmaceutical executive, was hired by Makary last spring.
Makary’s removal from his post at the FDA follows weeks of complaints from President Donald Trump’s political allies. anti-abortion groups And electronic cigarette lobbyistsThose who are disappointed with the agency’s direction.
Makary and Secretary of Health Robert F. Kennedy Jr. Hoeg, who worked closely with the FDA, had been managing the FDA’s drug program since December; Revolving door of FDA leadership changes.
Hoeg’s meteoric rise at the agency was engineered by Makary, who quickly promoted him from serving as his special assistant to running the agency’s largest headquarters, responsible for regulating most prescription and over-the-counter drugs in the United States.
FDA center directors are typically career agency scientists with decades of experience. Hoeg had no previous government or management experience.
Since arriving at the FDA last March, Hoeg has led research on the safety of injectable drugs. RSV medications for children, antidepressants and COVID-19 vaccines.
These questions reflected Hoeg’s longstanding interests and concerns before joining the government.
Hoeg, a sports medicine physician and public health scientist, first gained attention as a critic of masking, school closures, vaccine mandates and other government measures during the pandemic. He has co-authored articles with other medical opponents who will join the Trump administration, including Makary and Prasad.
Like Makary and Prasad, Hoeg has frequently voiced his opinions in blog posts and podcasts, including one titled “Vaccine Enthusiast.” The podcast discussed a number of discredited ideas, including that mRNA vaccines could contain harmful DNA contaminants.
Hoeg, a Danish American citizen, has been instrumental in the Trump administration’s recent efforts. Drop a series of federally recommended vaccines for childrenincluding those for influenza and hepatitis B at birth. These changes happened temporarily blocked by a federal judge in Boston, but the administration plans to appeal the decision.
At the FDA, Hoeg led an “initial analysis” of vaccine injuries that linked COVID-19 vaccines to 10 reported deaths in children, without providing supporting evidence. The findings were discussed in an internal memo Prasad sent to employees last November, but the FDA did not formally announce the findings or explain how they were developed.
Officials from the FDA and the Centers for Disease Control and Prevention have previously concluded that serious side effects from 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 medications about unproven pregnancy risks, including fetal abnormalities that could lead to autism and other disorders.
In March, he tried to recruit the petition’s author to serve as a senior advisor at the FDA, according to sources familiar with the situation. The issue raised concerns among some agency employees because Hoeg repeatedly referred to the person as a friend, according to people who spoke to the AP on condition of anonymity to discuss confidential FDA matters.
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