RFK ally confirms FDA dismissal: ‘I learned so much and leave with no regrets’

(SeaPRwire) –   A Food and Drug Administration official who played a key role in evaluating the safety of antidepressants, COVID-19 vaccines, and other widely used medications has been removed from her position leading the agency’s drug program.

Dr. Tracy Beth Hoeg will be succeeded as the FDA’s acting director of its center for drug evaluation by Dr. Mike Davis, who currently serves as deputy director, according to an email sent Friday to agency staff and obtained by The Associated Press.

In a social media post late Friday, Hoeg stated that she was “fired” from the agency, adding: “I learned so much and leave with no regrets.”

Hoeg’s departure marks another change in leadership at the influential regulatory agency. FDA Commissioner Marty Makary resigned earlier this week, and Dr. Vinay Prasad, the agency’s former head of vaccine and biotech oversight, stepped down last month after facing strong criticism from pharmaceutical companies, patient groups, and investors.

The agency also announced on Friday that Karim Mikhail would serve as the new acting director of the vaccines center. Mikhail, a veteran pharmaceutical executive, was hired by Makary last spring.

Makary’s resignation followed weeks of complaints from allies of President Donald Trump, including anti-abortion organizations and vaping industry lobbyists, who were dissatisfied with the direction of the agency.

Hoeg, closely aligned with both Makary and Health Secretary Robert F. Kennedy Jr., had led the FDA’s drug program since December, becoming the latest official to briefly hold the role amid ongoing turnover at the top of the agency.

Under Makary’s direction, Hoeg rapidly advanced within the agency—moving from special assistant to overseeing the largest center at the FDA, which regulates most prescription and over-the-counter drugs in the United States.

Typically, directors of FDA centers are experienced career scientists with decades of service within the agency. However, Hoeg had no prior government or management experience before joining the FDA.

Since joining the FDA in March, Hoeg directed investigations into the safety of injectable RSV treatments for children, antidepressant medications, and the administration of COVID-19 vaccinations.

These areas of focus reflected her preexisting interests and concerns prior to entering public service.

An expert in sports medicine and public health science, Hoeg first gained national attention during the pandemic for opposing mask mandates, school closures, vaccine requirements, and other government-imposed restrictions. She co-authored research papers with other medical figures later appointed to the Trump administration, including Makary and Prasad.

Like her colleagues Makary and Prasad, Hoeg often shared her views through blog posts and podcasts, one of which was titled “Vaccine Curious.” The podcast explored several debunked claims, such as the idea that mRNA vaccines could contain harmful DNA contaminants.

A Danish-American citizen, Hoeg helped lead the Trump administration’s recent push to eliminate certain federally recommended childhood immunizations, including influenza and hepatitis B shots given at birth. Those policy changes have been temporarily blocked by a federal judge in Boston, though the administration intends to appeal the ruling.

At the FDA, Hoeg oversaw what she described as an “initial analysis” linking COVID-19 vaccines to 10 reported deaths among children—without presenting supporting evidence for these findings. The results were included in an internal memo sent last November by Prasad to agency staff, although the FDA has not officially released the data or explained how it was compiled.

Officials from both the FDA and the Centers for Disease Control and Prevention have consistently maintained that serious side effects associated with the vaccines occur extremely rarely.

More recently, Hoeg participated in the agency’s review of a formal request to include bold new warnings on antidepressant labels regarding unproven risks during pregnancy, such as potential links to fetal abnormalities, autism, and other developmental disorders.

In March, she attempted to recruit the author of the petition to serve as a senior adviser at the FDA, according to individuals familiar with the matter. Some agency employees raised concerns because Hoeg had repeatedly referred to the person as a close friend, the sources told the AP on condition of anonymity due to the sensitive nature of the discussion.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.