FDA turmoil deepens as top drug chief departs claiming she was fired | US news
In a major shake-up at the US Food and Drug Administration (FDA), top regulators left on Friday – including Tracy Beth Høeg, the acting drug chief, who says she was fired, and Katherine Szarama, the acting vaccine chief who has only been in the role for a few days. Jim Traficant, the chief of staff, was also ousted.
The FDA now has no permanent commissioner or deputy commissioner and no permanent leaders of two major centers, after Marty Makary’s resignation Tuesday and other high-profile departures.
According to an email obtained by the Guardian, FDA staff only received formal word Friday afternoon that Makary was leaving and Kyle Diamantas, previously the top food regulator, will temporarily lead the agency as acting commissioner — although they had clues through President Donald Trump’s social media posts and the reported removal of Makary’s photo from the FDA headquarters lobby.
The departure of Makary and several key FDA allies means a potential new direction for the agency, which has been rocked by controversial decisions on vaccines, rare disease drugs, staff layoffs and low morale.
“I was fired,” Høeg wrote on
Høeg told the New York Times and other media outlets that she was fired from the agency after refusing to resign.
Before overseeing the National Drug Regulatory Center, Høeg was an advisor to Makary, and she focused on collecting reports on vaccine adverse reactions and trying to align the U.S. childhood vaccination schedule with that of Denmark, where Høeg has dual citizenship and earned her degree in epidemiology. A sports doctor, Høeg gained national prominence by questioning the safety and necessity of Covid vaccines, and she had no apparent experience regulating the drugs.
Høeg was the center’s fifth leader in a year, following the high-profile departures of leaders such as George Tidmarsh and Richard Pazdur.
Michael Davis, deputy director of CDER, will now serve as interim director, according to STAT News.
Szarama took over as interim director of the Center for Biologics Evaluation and Research (CBER) after the departure of another highly controversial figure, Vinay Prasad, last month. But Szarama, who had been on the job for 10 days and hadn’t even had time to update his LinkedIn profile, also reportedly left the agency. Karim Mikhail, who was CEO of pharmaceutical company Amarin before joining the FDA last year, will now temporarily lead the center.
Traficant, who was chairman and CEO of Citadel Sciences before joining the FDA last March, is also absent.
