A pair of top vaccine regulators at the U.S. Food and Drug Administration resigned this week reportedly as a result of growing turmoil and disagreement within the agency as political pressures reportedly complicate the administration’s scientific work.
Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy, Philip Krause, announced their intentions to leave the FDA with little fanfare on Tuesday. In a memo sent to news publishers, the FDA framed the decision as a simple retirement, thanking Gruber and Krause for their service but offering no reason for their forthcoming departure.
It seemed peculiar that two key vaccine officials would “retire” from the agency in the middle of a global pandemic and at a time when their expertise was most needed. Gruber, a veteran vaccine regulator, had been with the FDA for 32 years.
Sure enough, there was more bubbling under the surface.
In a report published Tuesday evening, Politico indicated the pair’s departure was the result of increasing frustration over the Biden administration’s top-down approach to managing the pandemic, specifically as it pertains to administering booster shots for adults:
FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters’ benefits before the administration’s Sept. 20 deadline for rolling them out to most adults …
… On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.
POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration’s disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.
The news outlet characterized Gruber and Krause’s exit as a symptom of a greater problem brewing within the FDA, even warning that a potential “mutiny” could be just around the corner.
Paul Offit, an infectious disease expert at the University of Pennsylvania who sits on FDA’s vaccine advisory committee, shared a similar sentiment, claiming the administration has pushed ahead on boosters without allowing FDA scientists to meaningfully weigh in.
“[It was] the administration’s booster plan; it wasn’t the FDA’s booster plan,” Offit told Politico. “The administration has kind of backed themselves up against the wall a little bit here.”
Moreover, disagreement over vaccine boosters may not be the only hot-button topic causing discord within the agency. The Hill reported on Monday that FDA regulators are facing “growing pressure to authorize vaccines for children under 12,” something the agency has so far been reluctant to do.