About This Project

Amend the Federal Food, Drug, and Cosmetic Act to require that when the FDA overrides an advisory committee recommendation, the Commissioner must publish a written justification specifically addressing the scientific objections raised by the committee, with that justification subject to independent scientific review within 90 days. The aducanumab case — 10-0-1 committee vote against, FDA approved — is only the most visible instance of a structural problem. Advisory committees are convened precisely because FDA staff cannot maintain deep expertise across every therapeutic area. When the agency can override their recommendation with a general reference to its own judgment, the committees serve a theatrical function rather than a scientific one. Three committee members resigned over aducanumab. That level of professional protest from academics who have nothing to gain from the controversy deserves a structural response, not a press release.

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