Whistleblower Alleges FDA Approved Medical Product Despite Experts’ Concerns

An employee of the FDA’s Center for Biologics Evaluation and Research says the agency rushed a first-of-its-kind medical product to market prematurely.

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/File Photo/Reuters

A former Food and Drug Administration (FDA) medical officer alleges that the agency’s Center for Biologics Evaluation and Research approved a novel medical product over the objections of four expert vascular surgeons.

At issue is a paragraph in an FDA letter approving the Biologics License Application for a first-of-its-kind vascular graft product with the brand name Symvess.