More top vaccine regulators out at FDA, threatening new approvals
More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to approve new vaccines and drugs.
More top vaccine regulators at the Food and Drug Administration have either left or been forced out following the resignation last week of Dr. Peter Marks, the agency’s top vaccine official, according to four former and current government officials familiar with the matter who spoke on the condition of anonymity for fear of retribution.
Experts say the exodus of top talent at the FDA’s Center for Biologics Evaluation and Research could hobble the agency’s ability to approve new vaccines and a wide range of other drugs — especially in the wake of the mass layoffs by the Department of Health and Human Services on Tuesday.
It also leaves a void of experienced staff at a time when distrust in vaccines and health institutions is growing.
“It represents a hollowing-out of the agency, and especially a tremendous loss of institutional memory,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said of the departures. “I’m not sure people realize how important that is, and we will suffer from this.”
Offit serves on an independent vaccine advisory committee for the FDA that convenes at CBER’s request.
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