FDA Appoints Dr. Tracy Beth Høeg as Acting Director of CDER, Announces New ONPD Leader
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The U.S. Food and drug Governance is undergoing a leadership shift with the appointment of Dr. Tracy Beth Høeg to lead its Center for Drug Evaluation and Research (CDER) and a new director for the Office of Nonprescription Drugs (ONPD), signaling a commitment to modernization and increased access to affordable medicines.
The FDA announced on December 3, 2025, that Tracy Beth Høeg, M.D., Ph.D., will serve as the acting director of CDER. Dr. Høeg brings a diverse background as a physician and epidemiologist to the role, having previously been a Visiting Scholar at the Massachusetts Institute of Technology Sloan School of management. Prior to joining the FDA, she practiced physical and interventional spine and sports medicine and served as Senior Advisor for Clinical Sciences in both the Office of the commissioner and the Center for Biologics Evaluation and Research (CBER).
Dr.Høeg’s academic credentials include a Doctor of Medicine from the Medical college of Wisconsin, a Doctor of Ideology in Public Health and Epidemiology from the University of Copenhagen, and a residency at the University of California, Davis.She has established herself as a prolific researcher, co-authoring 45 peer-reviewed publications in prominent medical journals such as 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,” stated FDA Commissioner Marty makary, M.D., M.P.H. He further highlighted her contributions at CBER, noting her commitment to “advancing scientific rigor…including our roadmap to reduce and replace animal testing with new technologies.”
Dr. Høeg expressed her dedication to the role, stating, “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective.” She pledged a commitment to “transparency, honesty, and decisions based on rigorous science” and emphasized her focus on “ensuring important changes happen efficiently.” She added that she is “humbled to support the FDA’s work to modernize and strengthen how we evaluate evidence so the public benefits from the best science.”
Expanding Access with New ONPD Leadership
Alongside the CDER appointment, the FDA also announced Karen Murry, M.D., as the new director of the Office of Nonprescription Drugs (ONPD). Dr. Murry will spearhead efforts to expand access to affordable over-the-counter (OTC) medications for Americans. This move underscores the agency’s commitment to increasing healthcare accessibility and reducing costs for consumers.
FDA’s Core Mission
The FDA, operating as an agency within the U.S. Department of Health and Human Services, remains dedicated to protecting public health. Its responsibilities encompass ensuring the safety, effectiveness, and security of a wide range of products, including human and veterinary drugs, vaccines, biological products, and medical devices. The agency also safeguards the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and regulates tobacco products.
The appointments of Dr.Høeg and Dr. Murry signal a new chapter for the FDA,one focused on scientific rigor,modernization,and a commitment to serving the health needs of the American public.
