FDA Director and Deputy Director of CBER step down

“The retirements of Dr. Marion Gruber, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, and Dr. Philip Krause, deputy director of the office, were announced in an internal agency email sent on Tuesday and shared with CNN by the FDA.”

“Officials within the FDA were stunned by the news that Gruber and Krause were leaving the agency. One described it as a ‘big loss’ for the FDA and noted that it caught leadership off guard. CNN has reported that morale at the agency, which still has no permanent leadership, has been eroded by the intense workload brought on by the pandemic.”

“A source familiar with the situation told CNN there have been frustrations within the FDA when it comes to vaccines.”

“…the largest issue seems to be that by setting a goal for boosters, the White House is getting ahead of where the science is and ‘prejudging what the FDA would say.’”

“Though Biden’s political aides have stressed their booster rollout plan relies entirely on decisions by the FDA and CDC, there is concern that they are publicly pre-judging the determination before all the data has been thoroughly reviewed.”

Source: CNN