A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting comm

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

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2021-06-17 19:30:02

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”).

On Wednesday, advocacy group Public Citizen only increased the din of criticism, calling the FDA’s approval “reckless.” The FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “The sheer recklessness of the FDA’s approval of aducanumab cannot be overstated. This decision is a disastrous blow to the agency’s credibility, public health and the financial sustainability of the Medicare program.” The latter point refers to the fact that Aduhelm’s developer, Biogen, set the drug’s list price at $56,000 for a year’s supply.

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