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2022-12-30| In-DepthSpecial

The FDA and Biogen Taking Heat for Aduhelm’s Approval Process

by Reed Slater
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Over a year after the FDA approved Biogen’s Alzheimer’s drug, Aduhelm, on the accelerated approval pathway, the U.S. House of Representatives published a report outlining the atypical processes leading to the drug’s approval. The report faults the FDA for abnormalities in documentation protocol, not adequately representing differing views within the regulatory agency, shifting to accelerated approval in a substantially short timeframe, and approving the drug for a broad label despite a lack of clinical evidence in a wider population. Biogen is under fire for accepting the broad label, knowing it did not test the drug in a broad population and setting a high price, and planning for substantial marketing costs, despite knowing the potential impact on patients and the Medicare system.

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