Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
Tracy Beth Høeg—a known vaccine skeptic—will lead the FDA’s Center for Drug Evaluation and Research as acting chief, becoming the fifth person just this year to hold the agency’s top drug regulatory post.
Høeg, who joined the FDA earlier this year as an aide to Commissioner Marty Makary, is a doctor who previously specialized in physical and interventional spine and sports medicine, according to an FDA news release on Wednesday. She served as a senior advisor in the Office of the Commissioner and at the Center for Biologics Evaluation and Research. Høeg holds a PhD in Public Health and Epidemiology from the University of Copenhagen.
“I am committed to transparency, honesty, and decisions based on rigorous science,” she said in a prepared statement on Wednesday. “I am humbled to support the FDA’s work to modernize and strengthen how we evaluate evidence so the public benefits from the best science.”
Høeg succeeds Richard Pazdur, who earlier this week announced his retirement from the FDA just weeks after he was convinced by Makary to head CDER. Pazdur himself inherited the seat from George Tidmarsh, who was appointed in July and resigned last month amid a probe into his personal conduct. Before Tidmarsh, CDER’s acting director was Jacqueline Corrigan-Curay, who assumed leadership of the division after Patrizia Cavazzoni stepped down in January.
CDER is the main office at the FDA responsible for regulating prescription and over-the-counter drugs, including generics and biological therapies.
Like other health appointees under the Trump administration, Høeg has long been a skeptic of vaccines, particularly of the COVID-19 shots. In October 2023, she wrote on her Substack that “the CDC will continue to mislead the public or simply push policy without doing the studies,” referring to the agency’s insistence on school closures during the pandemic, despite what she said was a lack of evidence showing a link between community spread and school reopening.
Later in that same post, she claimed that the CDC “started ignoring reports” of deaths related to myocarditis associated with the COVID-19 vaccines.
Høeg has continued to publicly criticize U.S. vaccination policy and in December 2024 spoke on a podcast questioning the current childhood schedule in the country.
More recently, Høeg’s work led to the claims by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, that “at least 10 children” died because of the COVID-19 vaccines. In an internal memo last week, Prasad wrote that “for the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.”
While the memo was light on actual data to support these claims, Prasad noted that it was Høeg who led the investigation into these mortalities, digging through reports in the FDA’s Vaccine Adverse Event Reporting System for reports of children who died after receiving the shot. Høeg was also the one who first “concluded” that the deaths were linked to the vaccines.