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Follow-up Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Unprecedented and Inappropriately Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab

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Following the stunning new disclosures in a detailed exposé published by STAT about how Biogen used a Food and Drug Administration (FDA) back channel to win approval for aducanumab for treatment of Alzheimer’s disease, Public Citizen again called on Department of Health and Human Services (HHS) Office of Inspector General to immediately launch a formal investigation to scrutinize the unprecedented and inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application for the new biologic drug aducanumab for treatment of Alzheimer’s disease.

July 20, 2021, response letter from the HHS Officer of Inspector General.

See Public Citizen’s other work on aducanumab.