The Food and Drug Administration entered deeper turmoil Friday as three senior officials departed within hours, including the acting head of the drug center who said she was terminated after refusing to resign.
Dr Tracy Beth Høeg, who led the Center for Drug Evaluation and Research, confirmed her firing on social media Friday night. She had served exactly six months in the role. Høeg told the New York Times and other outlets that she rejected an offer to step down voluntarily before being ousted.
Katherine Szarama, the acting vaccines chief, also departed after just 10 days on the job. She had been brought in to replace Vinay Prasad, who left the vaccines center last month. Jim Traficant, the FDA's chief of staff, was also removed.
The exits signal a dramatic reset at the agency, which now lacks a permanent commissioner, permanent deputy commissioner, and permanent leaders of two critical divisions. The instability intensified Friday afternoon when FDA staff received official notification that Marty Makary, who had led the agency, was departing. Most had learned the news from President Trump's social media posts and reports that Makary's photograph had been removed from agency headquarters.
Kyle Diamantas, previously the top food regulator, will temporarily assume the commissioner role. Michael Davis, CDER's deputy director, takes over as acting drug chief. Karim Mikhail, former CEO of the pharmaceutical company Amarin, will head the vaccines and biologics center.
Høeg became a nationally recognized figure by questioning the safety and necessity of Covid vaccines, despite having no prior experience in drug regulation. She held a degree in epidemiology from Denmark, where she is a dual citizen, and worked as a sports medicine physician before joining the FDA as an adviser to Makary. Her five-month tenure made her the fifth person to lead the drug center in just one year, following the high-profile exits of George Tidmarsh and Richard Pazdur.
The recent upheaval has engulfed the FDA in controversy over vaccine decisions, approvals for rare disease medications, staff reductions, and reported low morale across the agency. Makary's departure removes a key figure whose brief tenure reshaped the agency's direction and personnel.
Szarama's departure after 10 days marks one of the shortest tenures in recent agency memory. She had barely settled in before being pushed out, not even updating her professional biography online before the exit.
The rapid turnover at these three critical positions raises questions about continuity and leadership at an agency responsible for overseeing the safety and efficacy of the nation's drugs, vaccines, and biological products.
Author James Rodriguez: "The FDA is now running on fumes, with acting leaders stacked atop acting leaders while its permanent structure crumbles."
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