Silver Spring, Maryland — 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). This significant leadership transition is part of the agency’s broader efforts to enhance the evaluation and integration of drug safety and effectiveness.

Dr. Høeg, a physician with a background in epidemiology, previously served as a Visiting Scholar at the Massachusetts Institute of Technology’s Sloan School of Management. Her experience includes practicing physical and interventional spine and sports medicine, in addition to holding a Senior Advisor position for Clinical Sciences within the FDA’s Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).

She earned her medical degree from the Medical College of Wisconsin and obtained a Ph.D. in Public Health and Epidemiology from the University of Copenhagen. Dr. Høeg has contributed to a body of work that includes 45 peer-reviewed publications in prominent medical journals, such as the New England Journal of Medicine and the Annals of Internal Medicine.

FDA Commissioner Dr. Marty Makary praised Dr. Høeg’s qualifications, emphasizing her role in modernizing CDER and fostering collaboration across various FDA divisions. He noted her commitment to rigor in science, particularly in efforts to replace animal testing with innovative technologies, aligning with current trends in drug evaluation.

In her new role, Dr. Høeg expressed a deep commitment to transparency and rigorous scientific inquiry. “I’m dedicated to ensuring that we make decisions based on robust evidence,” she stated. She acknowledged the importance of CDER in safeguarding public health and highlighted her desire to support the FDA’s mission to improve drug assessment processes.

Accompanying this leadership change, the FDA has also appointed Dr. Karen Murry as the director of the Office of Nonprescription Drugs (ONPD). Dr. Murry will work to expand access to affordable over-the-counter medications for consumers.

The FDA, as part of the U.S. Department of Health and Human Services, plays a crucial role in ensuring the safety and efficacy of various health products, including veterinary drugs, vaccines, and medical devices, along with overseeing the safety of food and cosmetics. This leadership realignment is viewed as a vital step toward reinforcing the agency’s commitment to public health and innovation in drug safety.