2 top FDA officials resigned over the Biden administration’s booster-shot plan, saying it insisted on the policy before the agency approved it, reports say

President Joe Biden. AP/Manuel Balce Ceneta

  • The FDA announced the resignations of Marion Gruber and Philip Krause on Tuesday.

  • The pair lead the FDA office in charge of approving vaccines.

  • Politico and Endpoints reported that the pair left in frustration over Biden’s COVID booster plan.

  • See more stories on Insider’s business page.

The US Food and Drug Administration announced the resignations of two top vaccine officials on Tuesday, and reports said the two were leaving the agency in anger over the Biden administration’s plan to roll out COVID-19 booster shots before the officials had a chance to approve it.

Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA in October and November respectively. BioCentury first reported the news on Tuesday.

In a letter announcing the resignations, obtained by the biotech-industry publication Endpoints, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, praised the pair for their work during the COVID-19 pandemic. He didn’t give a reason for their departure.

But sources who spoke to Endpoints and Politico said Gruber and Krause were upset with Biden administration’s booster-shot plan. The Biden administration announced last month that most people will be offered a COVID-19 booster shot about eight months after vaccination.

One former senior FDA leader told Endpoints that Gruber and Krause were leaving the agency because they felt that the Centers for Disease Control and Prevention was making vaccine decisions that should have been left to the FDA, and were upset with Marks, the leader of their division, for not insisting that these decision be made by the FDA.

The source said the final straw was the Biden administration’s announcing plans to start booster shots before the FDA had officially signed off on the plan.

A former FDA official also told Politico that the resignations are tied to anger over the FDA’s lack of autonomy in booster planning, while a current official told the outlet that the pair are leaving over differences with Marks.

When asked about these reports on Tuesday, White House coronavirus czar Jeff Zients said the decision to start booster shots “was made and announced by the nation’s leading public health officials” including the acting FDA commissioner, the CDC director, the surgeon general, the director of the National Institutes of Health, and others.

“Having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” Zients said.

“We have been – also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”

The FDA, Gruber, Krause did not immediately respond to Insider’s request for comment.

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