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US FDA Advisory Committee Members Say Votes Should More Directly Affect Agency Decisions

Executive Summary

Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.

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Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.

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After a searing advisory committee on aducanumab, FDA reviewers undertook an extensive effort to counter or discount the panel’s criticisms, newly released review documents show. Among the unusual moves by the agency was the citation of data from two investigational products, Lilly’s donanemab and Biogen/Eisai’s BAN2401, as evidence in support of aducanumab.

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