Two of the FDA's top vaccine leaders are stepping down from their positions, Endpoints News reported Aug. 31, citing an internal letter sent to FDA staff.
Marion Gruber, PhD, director of the FDA's Office of Vaccines Research & Review, will retire Oct. 31. She's been with the FDA for 32 years. Phil Krause, MD, the vaccine office's deputy director, will leave in November, according to the letter from Peter Marks, MD, PhD, who leads the agency's Center for Biologics Evaluation and Research.
A former senior FDA leader told Endpoints News the two leaders are stepping down from their roles because they're frustrated that the CDC and its Advisory Committee on Immunization Practices are involved in decisions they believe should be the FDA's. The White House's announcement that booster shots would be available Sept. 20, which was made without the FDA's approval, was reportedly what prompted the two leaders to step down.
The FDA's former acting chief scientist Luciana Borio, MD, tweeted Aug. 31: "FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service."
Rick Bright, PhD, former director of the Biomedical Advanced Research and Development Authority, tweeted: "These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of [the Center for Biologics Evaluation and Research]. A huge global loss if they both leave."
Dr. Marks wrote in the letter to staff announcing the departures: "Marion's departure is a huge loss for CBER and FDA. We wish her all the best in her next chapter, and a well-deserved congratulations for a remarkable career."
"Sincere thanks and congratulations to Phil for his incredible contributions to public health over the course of his impressive career in the U.S. Public Health Service and with CBER," he added.
Dr. Marks said the search for the next director will begin soon, and he will serve as the acting director during the search. He said he will announce details for an acting deputy director at a later date.
Acting FDA Commissioner Janet Woodcock, MD, told Endpoints News that she wishes both leaders well and thanks them for their service.
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