Wedoany.com Report-Dec.5, The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as acting director of the Center for Drug Evaluation and Research (CDER), effective immediately following the announcement on December 3, 2025. This change occurs amid ongoing transitions in agency leadership.

Tracy Beth Hoeg has been appointed as the FDA’s new CDER lead, making her the fifth person to take this position in 2025.

Høeg's selection comes shortly after the retirement of Richard Pazdur, a veteran FDA employee who assumed the CDER role less than a month earlier, on November 11, 2025. Pazdur, previously known for his work in oncology regulation, stepped down at the end of December 2025.

Pazdur had been encouraged by FDA Commissioner Marty Makary to lead CDER after the resignation of prior director George Tidmarsh. Tidmarsh left the position following an internal review that identified concerns related to his personal conduct.

Høeg, a physician specializing in sports medicine and an epidemiologist, joined the FDA in March 2025 as a special assistant to Makary. She later served in senior advisory roles within the Center for Biologics Evaluation and Research (CBER) and the Office of the Commissioner, including as Senior Advisor for Clinical Sciences since May 2025.

In her professional background, Høeg has focused on areas such as orthobiologic medicine, including platelet-rich plasma, proliferative therapy, and bone marrow aspirate concentrate. Prior to her FDA tenure, she worked as a visiting scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine medicine.

Makary praised Høeg's qualifications, stating: “Dr. Høeg is the right scientist to fully modernize CDER,” while establishing a “culture of cross-center coordination.”

Høeg expressed her commitment in a statement: “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective. This is an incredible opportunity to serve my fellow Americans. I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently.”

This appointment marks Høeg as the fifth individual to lead CDER in 2025. Earlier that year, Patrizia Cavazzoni retired in January amid preparations for the new administration, and Jacqueline Corrigan-Curay stepped down in June. The sequence of changes highlights a period of adjustment within the division responsible for evaluating most prescription and over-the-counter drugs.

Beyond CDER, the FDA has experienced broader leadership shifts this year. Vinay Prasad, who briefly headed CBER, departed after three months but returned two weeks later at the agency's request. His predecessor, Peter Marks, resigned due to differences in approaches to certain health policies. In the cell and gene therapy area, Nicole Verdun, head of the Office of Therapeutic Products (OTP), and her deputy Rachel Anatol were placed on administrative leave in June 2025.

These transitions coincide with operational challenges, including staff reductions and delays in drug reviews stemming from a recent government shutdown. The agency continues to prioritize scientific evaluation and coordination across its centers to support public health needs.