Tracy
Beth
Høeg
M.D., Ph.D.
Leadership Role
Acting
Director - Center for Drug Evaluation and Research
Tracy Beth Høeg is the Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER). CDER’s mission is to ensure that safe, effective, and high-quality drugs are available to the public. To achieve this, CDER regulates the medical products under its jurisdiction throughout their lifecycle – overseeing the development of new and generic drugs, evaluating applications to determine whether drugs should be approved, monitoring the safety of drugs after they are marketed, conducting research to advance regulatory science, and taking enforcement actions to protect the public from harmful products.
Dr. Høeg joined the FDA in March 2025, first as a Special Assistant and then as Senior Advisor for Clinical Sciences to Commissioner Marty Makary, M.D., M.P.H. Among her achievements was her work on the Commissioner’s roadmap to reduce and replace animal testing, and related work on developing an internal drug and compound database for computational modeling of drug safety and efficacy, organization of a panel to discuss the safety of SSRIs in pregnancy, and an interagency workshop on reducing animal testing. She also helped lead recent innovations in vaccine safety surveillance methodologies with The Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research.
Prior to joining the FDA, Dr. Høeg served as a visiting scholar at the Massachusetts Institute of Technology, Sloan School of Management, and as an Adjunct Associate Professor at the University of Southern Denmark. She also worked in Dr. Vinay Prasad’s lab at the University of California San Francisco’s Department of Epidemiology and Biostatistics, where they co-authored numerous scientific publications, including one in the New England Journal of Medicine on healthy vaccine bias.
Between 2020 and 2025 she worked as a physician specializing in physiatry at Northern California Orthopaedic Association, where she focused on interventional spine and sports medicine.
Dr. Høeg received her B.A. in French with Honors in the major from the University of Wisconsin-Madison, and her M.D. from the Medical College of Wisconsin. She did a transitional medicine internship at the Gundersen Lutheran Medical Center in La Crosse, Wisconsin. She received a Ph.D. in Public Health and Epidemiology from the Faculty of Health and Medical Sciences University of Copenhagen and did a residency in physiatry (physical medicine & rehabilitation) at the University of California-Davis, and a Fellowship in Interventional Spine & Sports Medicine at the Bodor Clinic in Napa, California.
Dr. Høeg has authored or co-authored more than 40 peer-reviewed articles and has testified before congressional committees and subcommittees on research she has done relating to Covid-19 policies and is a former cohost of the podcast Vaccine Curious. She is the mother of four children and an ultramarathon runner, having competed twice in world championship long distance running events. Dr. Høeg holds dual citizenship in the U.S. and Denmark.