Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug

Stat News

9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen in readying an application for regulatory approval to market its controversial Alzheimer’s treatment.

In a scathing letter to the Office of Inspector General at the Department of Health and Human Services, the advocacy group Public Citizen accused the FDA of “unbridled enthusiasm” for the medicine and for pursuing “unprecedented” cooperation with the biotech company, which has “dangerously compromised the independence and objectivity” of FDA senior staff and clinical reviewers.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation