Key Departments at FDA Undergo Recent Leadership Changes

By Pete Evich, Vice President, Van Scoyoc Associates 

On December 3, FDA Commissioner Commission Marty Makary named Dr. Tracy Beth Høeg as the acting director of Center for Drug Evaluation and Research (CDER). CDER is the largest center within FDA and is responsible for regulating most prescription and over-the-counter medications. 

Dr. Høeg lands at CDER after the recent resignations of two previous directors, Dr. George Tidmarsh, who resigned from the post in early November, and Dr. Richard Pazdur, who served as head of the center for only three weeks before announcing he was retiring after spending 32 years at the agency. 

Høag previously served as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER). Her academic and professional background includes: 

• An M.D. from the Medical College of Wisconsin 

• A Ph.D. in Public Health and Epidemiology from the University of Copenhagen 

• Residency training in Physical Medicine & Rehabilitation at the University of CA, Davis 

• Visiting scholar at MIT’s Sloan School of Management 

• Practicing physical and interventional spine and sports medicine 

• Co-authoring more than 40 peer-reviewed scientific publications on topics including epidemiology and clinical evidence 

Dr. Høeg became more publicly known during and after the COVID-19 pandemic for her research and commentary on transmission in schools and vaccine-related outcomes. She has been described in press reports as critical of certain pandemic policies—including school closures, mask mandates for children, and some childhood vaccine recommendations—and has advocated for scrutiny of vaccine mandates and safety signals. 

Dr. Høeg’s elevation to CDER director has drawn notice and some controversy. Supporters cite her scientific credentials and experience in epidemiology as assets for modernizing drug evaluation, while some public health experts and agency insiders have expressed concern about her views on vaccines and her relatively limited experience in drug regulation and clinical trial oversight. Clearly though, her appointment reflects the current FDA leadership’s priorities and broader shifts within the agency. 

Parallel to the appointment of Høeg to head up CDER, the Office of Nonprescription Drugs—a key office within CDER that oversees non-prescription product regulation—also saw a major leadership change. Longtime director Dr. Theresa Michele was removed from her post in early December and reassigned to a different part of the agency. With Michele’s departure, Dr. Karen Murry was named to lead the Office of Nonprescription Drugs (ONPD). 

Before becoming ONPD director, Murry served for several years as Deputy Director at ONPD, working on a wide range of OTC drug categories. She has been involved in highprofile OTC regulatory deliberations and product reviews. 

Murry’s leadership at the Office of Non-Prescription Drugs places her at the center of FDA efforts to expand consumer access to nonprescription and address barriers to and opportunities to broaden OTC availability, which are priorities of Commissioner Makary. 

There is no public record of how either Dr. Høag or Dr. Murry view homeopathic drugs or what, if anything, their ascendancy to these leadership roles may mean in regard to the FDA’s oversight of the category.