The turmoil at the US Food and Drug Administration (FDA) escalated further on Friday as top regulators departed, including Dr. Tracy Beth Hoeg, the acting drug chief, who claims she was fired, and Katherine Szarama, the acting vaccines chief who had only held the position for a matter of days. Jim Traficant, the chief of staff, was also ousted.
Leadership Vacuum at the FDA
The agency now lacks a permanent commissioner, deputy commissioner, and permanent leaders for two major centers, following the resignation of Marty Makary on Tuesday and other high-profile departures. According to an email obtained by the Guardian, FDA staff were officially informed on Friday afternoon that Makary was leaving and that Kyle Diamantas, previously the top food regulator, would temporarily lead the agency as acting commissioner. However, staff had already suspected changes based on President Donald Trump’s social media posts and the reported removal of Makary’s photo from the FDA headquarters lobby.
Hoeg Claims She Was Fired
“I was fired,” Hoeg wrote on X on Friday night, noting that she had served exactly six months as head of the Center for Drug Evaluation and Research (CDER), though she did not mention that her role was acting, not permanent. Hoeg told the New York Times and other outlets that she was fired after declining to resign. Before overseeing the nation’s drug regulation center, Hoeg served as an adviser to Makary, focusing on gathering reports of adverse vaccine reactions and attempting to align the US childhood vaccine schedule with that of Denmark, where she holds dual citizenship and earned her epidemiology degree. A sports medicine physician, Hoeg rose to national prominence by questioning the safety and necessity of Covid vaccines, despite having no apparent experience in drug regulation. She was the fifth leader of CDER in a year, following the departures of George Tidmarsh and Richard Pazdur. Michael Davis, CDER’s deputy director, will now serve as acting director, according to STAT News.
Szarama and Traficant Also Out
Szarama took over as acting director of the Center for Biologics Evaluation and Research (CBER) after the departure of Vinay Prasad last month. However, Szarama, who had been in the position for only 10 days and had not even updated her LinkedIn profile, is also reportedly leaving the agency. Karim Mikhail, former CEO of Amarin who joined the FDA last year, will temporarily head CBER. Traficant, who was chair and CEO of Citadel Sciences before joining the FDA in March, is also out. The departures of Makary and several key allies signal a potential new direction for the FDA, which has been rocked by controversial decisions on vaccines, rare disease medications, staff layoffs, and low morale.
