FDA officials asked to step down after contentious Alzheimer’s drug approval

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration-including its acting commissioner-after the regulator issued a highly contentious approval last week of the unproven and now highly priced Alzheimer's drug Aduhelm (generic name: aducanumab).

The call for fresh FDA leadership comes atop a chorus of harsh criticism over the decision, which outside researchers and industry experts have called disgraceful" and dangerous," among other things.

Since Aduhelm's approval was announced June 7, three expert advisers to the FDA have resigned in protest, with one calling the decision probably the worst drug-approval decision in recent US history." The three experts were part of an 11-member advisory committee that reviewed the clinical data for the Alzheimer's drug last November and voted nearly unanimously against approval (10 voted against, 1 voted uncertain").

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