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Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?

 
• By Brenda Sandburg

After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.

advisory committee firestorm
US FDA approval of Alzheimer's disease drug Aduhelm riles advisory panel • Source: photo illustration/Alamy images

Among the criticisms the US Food and Drug Administration is facing following its approval of the Biogen, Inc./Eisai Co., Ltd. Alzheimer’s disease drug Aduhelm (aducanumab) is that the decision ran counter to the recommendations of the advisory committee the agency convened to review the product.

Three members of the Peripheral and Central Nervous System Drugs Advisory Committee have now resigned, expressing frustration at not being consulted on the accelerated approval and the agency’s disregard of the committee’s virtually unanimous rejection of the drug

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