The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as the acting director of the Center for Drug Evaluation and Research (CDER), marking a significant leadership shift at one of the agency’s most influential divisions. CDER plays a central role in protecting public health by ensuring that prescription and over-the-counter medications are safe, effective, and backed by sound scientific evidence.
Dr. Høeg brings an extensive background in medicine, epidemiology, and clinical research to her new role. Before joining the FDA, she served as a Visiting Scholar at the Massachusetts Institute of Technology’s Sloan School of Management, where her work intersected scientific innovation and healthcare systems. She also practiced physical and interventional spine and sports medicine, bringing hands-on clinical experience to her subsequent public service.
Her academic and professional credentials are equally notable. Dr. Høeg earned her medical degree from the Medical College of Wisconsin, followed by a Ph.D. in Public Health and Epidemiology from the University of Copenhagen. She completed her residency at the University of California, Davis. Over the course of her career, she has contributed to 45 peer-reviewed publications across leading journals such as the New England Journal of Medicine, Pediatrics, BMJ Evidence-Based Medicine, the Morbidity and Mortality Weekly Report, Annals of Internal Medicine, the Journal of Infection, and the International Journal of Epidemiology.
FDA Commissioner Marty Makary, M.D., M.P.H., praised the appointment, highlighting Dr. Høeg’s commitment to scientific integrity and her track record of strengthening evidence-based practices. “Dr. Høeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there,” he said. At CBER, he noted, she helped advance scientific rigor and played a key role in the agency’s roadmap to reduce and eventually replace animal testing with innovative technologies.
In accepting the position, Dr. Høeg emphasized the responsibility and privilege of leading CDER at a pivotal time. “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” she said. She expressed a strong commitment to transparency, honesty, and scientific rigor, noting her intention to help advance the FDA’s modernization goals and ensure that changes benefiting public health are implemented efficiently.
Alongside this leadership transition, the FDA also announced the appointment of Karen Murry, M.D., as the new director of the Office of Nonprescription Drugs (ONPD). Dr. Murry will guide ONPD’s efforts to expand access to affordable over-the-counter medications, supporting the agency’s broader mission of improving healthcare accessibility for the American public.
Dr. Høeg’s appointment signals the FDA’s continued focus on modernizing its approach to evaluating scientific evidence and strengthening the regulatory framework that governs the nation’s drug supply. As the agency navigates emerging technologies, evolving public health challenges, and increasing expectations for transparency, her leadership is expected to play a central role in shaping the future of drug oversight in the United States.