FDA names Tracy Beth Høeg as the fifth CDER head of the year

The United States Food and Drug Administration (FDA) has announced Tracy Beth Heg as the new director of its Center for Drug Evaluation and Research (CDER), marking yet another leadership transition in a period of agency instability. Hegs selection comes shortly after the unexpected resignation of Richard Pazdur, who had assumed the CDER leadership less than a month prior. Pazdur had been encouraged to take the position by FDA Commissioner Marty Makary following the departure of George Tidmarsh, who left after an internal probe raised concerns about his conduct.

Tracy Beth Heg, a trained sports medicine physician and epidemiologist, initially joined the FDA in March 2025 as a special assistant to Makary. Since then, she has held two senior advisory roles in both the Center for Biologics Evaluation and Research (CBER) and the Office of the Commissioner. During her tenure, she has expressed reservations regarding COVID-19 vaccine safety and effectiveness, including booster approvals for children and mask mandates.

Prior to this appointment, Heg was highlighted in the media when Vinay Prasad, CBERs director, claimed that research under her supervision identified ten child fatalities potentially linked to COVID-19 vaccines. While evidence to substantiate these claims has not been released, they have fueled debates about stricter vaccine oversight, supported by Health Secretary Robert F. Kennedy Jr., creating friction with federal health policy.

In her biography on Dignity Healths website, Heg emphasized her interest in orthobiologic treatments, including platelet-rich plasma therapy, proliferative therapy, and bone marrow aspirate concentrate. Despite her short tenure, Makary described her as the right scientist to modernize CDER and to foster cross-center collaboration across the FDA.

Rapid Leadership Changes at CDER and the FDA

Heg becomes the fifth person to lead CDER this year, joining predecessors Pazdur, Tidmarsh, Patrizia Cavazzoni, and Jacqueline Corrigan-Curay. Cavazzoni retired in January, Corrigan-Curay stepped down in June, and Pazdur served briefly before Hegs appointment. Leadership shifts have not been limited to CDER; several other key positions across the FDA have seen abrupt resignations, retirements, and reinstatements, including the head of CBER, Vinay Prasad, and Peter Marks, who resigned over vaccine policy disagreements.

The FDA has also faced administrative upheaval within its cell and gene therapy divisions. Nicole Verdun, director of the Office of Therapeutic Products (OTP), and her deputy, Rachel Anatol, were placed on administrative leave in June 2025. Concurrently, agency layoffs and delays in drug evaluations, partly due to recent government shutdowns, have continued to strain operations.

Author: Logan Reeves