Unwanted advice? Frequency, characteristics and outcomes of negative advisory committee votes for FDA approved drugs

Health Affairs

2 May 2022 - Substantial controversy arose in 2021 when the FDA approved the Alzheimer’s disease drug aducanumab (Aduhelm) under its accelerated approval program despite a nearly unanimous negative advisory committee vote. 

Advisory committees are convened before some FDA decisions to provide insight for the agency’s decision-making process. 

To understand the frequency, characteristics, and outcomes of cases in which the FDA authorises a drug against the recommendations of an advisory committee, we reviewed all FDA advisory committee referrals for new drugs approved during the period 2010–21.

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Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Expert opinion