FDA Leadership Shakeup: Tracy Beth Høeg Named Acting CDER Chief Amid Vaccine Controversy

The U.S. Food and Drug Administration (FDA) has appointed Dr. Tracy Beth Høeg as the acting director of its Center for Drug Evaluation and Research (CDER), marking the fifth leadership change in this critical role this year. The appointment comes amid ongoing debates surrounding vaccine safety and regulatory practices within the agency.

Rapid Leadership Transitions at CDER

Dr. Høeg's appointment follows a series of rapid changes in CDER's leadership:

• Patrizia Cavazzoni stepped down in January 2025
• Jacqueline Corrigan-Curay briefly assumed leadership
• George Tidmarsh was appointed in July but resigned in November amid a personal conduct probe
• Richard Pazdur took over in November, only to announce his retirement weeks later

These frequent transitions have raised concerns about stability within one of the FDA's most crucial divisions, responsible for regulating prescription and over-the-counter drugs, including generics and biological therapies.

Høeg's Background and Recent FDA Work

Dr. Høeg, who joined the FDA earlier this year as an aide to Commissioner Marty Makary, brings a unique background to her new role:

• Previously specialized in physical and interventional spine and sports medicine
• Holds a PhD in Public Health and Epidemiology from the University of Copenhagen
• Served as a senior advisor in the FDA's Office of the Commissioner and at the Center for Biologics Evaluation and Research

Since joining the FDA, Dr. Høeg has been involved in controversial investigations into vaccine safety. According to Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, Høeg led an investigation into reports of children dying after receiving COVID-19 vaccines. This work has reportedly led to claims that "at least 10 children" died because of the vaccines, although these claims have yet to be independently verified.

Vaccine Skepticism and FDA Criticism

Dr. Høeg's appointment has drawn attention due to her history of vaccine skepticism and criticism of U.S. health agencies:

• Known for challenging COVID-19 policies and questioning the CDC's guidance on school closures during the pandemic
• Publicly criticized U.S. vaccination policy, including questioning the current childhood vaccination schedule
• Co-authored a paper with FDA Commissioner Makary on the risks of COVID-19 vaccine boosters for young adults in 2022
• Previously outlined perceived failings of the FDA in a blog post titled "FDA's shortcomings: A list"

Her stance on these issues has raised questions about potential shifts in FDA policy and regulatory approach under her leadership.