Twelve former FDA commissioners raised concerns about proposed changes to vaccine regulation, warning the agency’s new direction could erode scientific standards and public trust.
In a letter published Dec. 3 in The New England Journal of Medicine, the group criticized a memo from Vinay Prasad, MD, who leads the FDA’s Center for Biologics Evaluation and Research. The memo discourages internal dissent, calls for scientific debate to remain private and proposes ending the agency’s longstanding use of immunobridging studies in vaccine approvals.
The former commissioners said the changes would delay timely vaccine updates, increase costs and limit access, particularly for high-risk patients. They also objected to the agency’s stated intent to bypass public advisory committees, calling the approach opaque and unscientific.
The group wrote that the FDA’s credibility depends on open evidence review and pluralism, not unilateral mandates: “Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns … without fear of reprisal.”
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