Posted by Michael Wonder on 03 May 2022
Unwanted advice? Frequency, characteristics and outcomes of negative advisory committee votes for FDA approved drugs
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.
