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

The United States Food and Drug Administration (FDA) has appointed Tracy Beth Heg as the new head of its Center for Drug Evaluation and Research (CDER), continuing a series of rapid leadership shifts within the agency.

Heg takes over shortly after the unexpected departure of Richard Pazdur, who had been appointed CDER director less than a month prior. Pazdur assumed the role following the resignation of George Tidmarsh, who stepped down amid an investigation into personal conduct that raised serious concerns.

Tracy Beth Heg is trained as a sports medicine physician and epidemiologist. She joined the FDA in March 2025 as a special assistant to Commissioner Marty Makary and subsequently held senior advisory roles at both the Center for Biologics Evaluation and Research (CBER) and the Office of the Commissioner. During her tenure, she has publicly questioned the safety and effectiveness of COVID-19 vaccines, including booster shots for children, and has criticized mask mandates.

Heg recently drew attention when Vinay Prasad, the head of CBER, stated that research under her leadership linked COVID vaccines to the deaths of ten children. Although evidence for these claims has not been released, the findings were cited to advocate for stricter vaccine regulation alongside Health Secretary Robert F. Kennedy Jr., creating tension with the Trump administrations policies. Former FDA commissioners have expressed concerns about these recent shifts in vaccine policy and guidance.

In a biography published on the website of Dignity Health, a nonprofit hospital network, Heg highlighted her interest in orthobiologic therapies, including platelet-rich plasma, proliferative therapy, and bone marrow aspirate concentrate. Commissioner Makary described her as the right scientist to modernize CDER while fostering cross-center coordination.

Frequent Leadership Changes at CDER

Heg is the fifth CDER director appointed this year. Prior to her, Pazdur and Tidmarsh held the position, as well as Patrizia Cavazzoni and Jacqueline Corrigan-Curay. Cavazzoni retired in January with the incoming Trump administration, while Corrigan-Curay resigned in June. Leadership instability extends beyond CDER, with multiple top FDA officials either leaving or being temporarily removed from office.

Vinay Prasad briefly resigned as CBER head but returned two weeks later at the FDAs request. Peter Marks, another former CBER director, also stepped down due to disagreements over vaccine policy with RFK Jr. Changes have also affected the cell and gene therapy division, with Nicole Verdun and her deputy Rachel Anatol placed on administrative leave in June 2025.

Amid this upheaval, the FDA has experienced workforce reductions and ongoing delays in drug approvals, compounded by the recent government shutdown.

Author: Olivia Parker