Tracy Beth Høeg, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research, was fired from the agency May 15 after she declined to resign, she told The New York Times. Her departure comes days after FDA Commissioner Marty Makary, MD, stepped down amid reported clashes with White House and HHS officials over agency policy decisions.
Eight things to know:
1. Dr. Høeg, who became the FDA’s top drug regulator in December, posted about her departure May 15 on X. “Today marked 6 months as head of CDER at @FDA & today I was fired,” she wrote. “I’m incredibly grateful to have had this opportunity to serve this country & proud of the work we did. FDA staff are smart, talented, supportive & don’t get enough credit. I learned so much & leave with no regrets.”
2. Dr. Høeg told The New York Times she was unsure who ordered her firing or why, nor whether HHS Secretary Robert F. Kennedy Jr. knew of the decision. HHS did not immediately respond to the publication’s request for comment. Becker’s reached out to the FDA and will update this story if more information becomes available.
3. Reuters first reported May 15 that Dr. Høeg was expected to leave the agency following Dr. Makary’s departure, citing three people familiar with internal planning. The publication reported the departures were part of a broader shake-up at HHS and the FDA as the White House increased oversight of the agencies and sought new leadership appointments.
4. During her tenure, Dr. Høeg drew scrutiny over several regulatory and vaccine policy positions. Reporting from outlets including The New York Times, Reuters and NBC News pointed to disagreements over COVID-19 vaccine policy, respiratory syncytial virus RSV treatment safety reviews and certain drug approval decisions.
5. HHS spokesperson Emily Hilliard said in a statement shared with NBC News earlier May 15 that the administration is “actively searching for strong candidates for key leadership positions across HHS, including the FDA, with a focus on experienced individuals who can strengthen agency operations, continue to advance significant reforms, and maintain public trust.”
6. Dr. Høeg joined the FDA in March 2025 as a special assistant and later served as senior adviser for clinical sciences to Dr. Makary before becoming acting CDER director.
7. Prior to joining the FDA, Dr. Høeg served as a visiting scholar at the Cambridge-based Massachusetts Institute of Technology Sloan School of Management and as an adjunct associate professor at the University of Southern Denmark. She also worked with Vinay Prasad, MD, at the University of California San Francisco’s Department of Epidemiology and Biostatistics and practiced physiatry, interventional spine and sports medicine in Northern California.
8. Kyle Diamantas, the FDA’s deputy commissioner for food, is serving as acting FDA commissioner on a temporary basis after Dr. Makary’s resignation. Michael Davis, MD, PhD, CDER’s deputy center director, is serving as acting director of the drug center, according to the FDA’s website.
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