Dr. Tracy Beth Høeg Appointed Acting Director Of The FDA Center for Drug Evaluation and Research (CDER)

Dr. Tracy Beth Høeg, who led an investigation into deaths following COVID-19 vaccination, is now the Food and Drug Administration’s (FDA) top drug regulator.  Høeg has worked closely with Dr. Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research (CBER):

https://www.fda.gov/news-events/press-announcements/fda-announces-leadership-appointments-center-drug-evaluation-and-research

FDA Announces Leadership Appointments at Center for Drug Evaluation and Research
For Immediate Release:
December 03, 2025

The U.S. Food and Drug Administration (FDA) today announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER). A physician and epidemiologist, Dr. Høeg was a Visiting Scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine and sports medicine before joining the FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).

Dr. Høeg completed her Doctor of Medicine at the Medical College of Wisconsin, Doctor of Philosophy in Public Health and Epidemiology at the University of Copenhagen, and residency at the University of California, Davis. She has co-authored 45 peer-reviewed publications, including in the New England Journal of Medicine, Pediatrics, BMJ Evidence-Based Medicine, Morbidity and Mortality Weekly Report, Annals of Internal Medicine, Journal of Infection, and International Journal of Epidemiology.

“Dr. Høeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there,” said FDA Commissioner Marty Makary, M.D., M.P.H. “At CBER, she advanced scientific rigor through her commitment to providing the public with the highest quality of evidence, including our roadmap to reduce and replace animal testing with new technologies.”

“CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” said Dr. Høeg. “This is an incredible opportunity to serve my fellow Americans. I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently. 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.”

As part of its CDER modernization implementation, the FDA also announced a new leader of its Office of Nonprescription Drugs (ONPD). Karen Murry, M.D., will serve as director of ONPD and lead its efforts to deliver affordable over-the-counter options to the American people.