Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event

A new study finds the agency only approved a product despite a negative advisory committee vote six times in six years. The overall rate of agreement between the agency and advisory committees has increased since 2015.

Agreement
FDA-advisory committee agreement was higher among priority applications compared to standard applications. • Source: Shutterstock

The shock and outrage in some circles over the US Food and Drug Administration’s surprise accelerated approval of Biogen, Inc.’s Alzheimer’s treatment Aduhelm (aducanumab-avwa) in 2021 stemmed partly from the agency’s disagreement with its outside advisers, an already uncommon event that data suggests is becoming even more rare.

A study by 3D Communications of all FDA advisory committee votes and drug, biologic and device application decisions from 2017 through 2022 found that the FDA agreed with committee decisions...

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