Tracy Beth Høeg has been appointed as the acting chief of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), making her the fifth person to lead the agency’s top drug regulatory post this year.
Høeg, who joined the FDA earlier in 2025 as an aide to Commissioner Marty Makary, previously worked as a doctor specializing in physical and interventional spine and sports medicine. According to an FDA news release, she has also served as a senior advisor both 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,” Høeg said in a statement released 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.”
She succeeds Richard Pazdur, who announced his retirement from the FDA earlier this week after serving only briefly as CDER chief. Pazdur had been convinced by Makary to take on CDER leadership after George Tidmarsh, who was appointed in July but resigned last month following an investigation into his personal conduct. Before Tidmarsh, Jacqueline Corrigan-Curay served as acting director after Patrizia Cavazzoni stepped down in January.
The CDER is responsible for regulating prescription drugs, over-the-counter medications, generics, and biological therapies.
Høeg is known for her critical stance on vaccines, particularly COVID-19 vaccinations. In October 2023 on her Substack blog, she wrote that “the CDC will continue to mislead the public or simply push policy without doing the studies,” referring to school closures during the pandemic despite what she described as insufficient evidence linking community spread with reopening schools.
In that same post, she also claimed that the Centers for Disease Control and Prevention (CDC) “started ignoring reports” of deaths related to myocarditis associated with COVID-19 vaccines.
Her skepticism regarding U.S. vaccination policies continued into December 2024 when she appeared on a podcast questioning current childhood immunization schedules.
Recently, Høeg led investigations into reports of children dying after receiving COVID-19 vaccines using data from the FDA’s Vaccine Adverse Event Reporting System. Vinay Prasad, director of FDA’s Center for Biologics Evaluation and Research, referenced her findings in an internal memo last week: “for the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.” Prasad stated that Høeg conducted reviews which concluded there were links between these deaths and vaccination; however, he noted limited data supporting these claims within his memo.
