President Joe Biden. Manuel Balce Ceneta/AP
On Tuesday, the FDA announced that Marion Gruber (resigning) and Philip Krause (resigning) had been made public by FDA.
They are the leaders of the FDA office responsible for approving vaccines.
Endpoints and Politico reported that they were frustrated by Biden's COVID-19 booster shot plan.
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Two top officials from the US Food and Drug Administration resigned Tuesday. Reports said they were angry at the Biden administration's plans to distribute COVID-19 booster shot before official approval.
Dr. Marion Gruber (director of the FDA's Office of Vaccines Research and Review), and Dr. Philip Krause (her deputy), plan to leave FDA in October and November. BioCentury reported the news Tuesday.
Endpoints published a letter in which Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, acknowledged the work of the two men during the COVID-19 pandemic. He did not give any reason for their departures.
Endpoints and Politico were told by sources that Gruber and Krause were unhappy with the Biden administration's booster shot plan. Last month, the administration announced that most people would receive a COVID-19 booster vaccine approximately eight months after their last vaccination.
Endpoints was told by a former top FDA leader that Gruber and Krause had left because the Centers for Disease Control and Prevention made vaccine decisions that should be left to the FDA. They were angry at Marks, their leader, for failing to insist on oversight.
According to a source, the FDA had not officially approved the booster-shot plan until the Biden administration announced it.
Politico was told by a former FDA official that resignations were due to anger at the FDA's inability to plan boosters autonomously. A current official said that the two were leaving because of differences with Marks.
Continue the story
Jeff Zients, White House coronavirus czar said that the decision to begin booster shots was made by and announced by "the nation's leading public health officials", including the acting FDA Commissioner, CDC director, surgeon general, director of the National Institutes of Health and others.
Zients stated, "After reviewing all the data available, it is in their clinical judgement that it is time for Americans to receive a booster shot."
He stated that the administration has "also been very explicit throughout that this is pending FDA's independent evaluation and CDC panel of outside experts issuing a recommendation for a booster dose."
Insider reached out to Gruber, Krause, and FDA for further information.
Business Insider has the original article.
