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Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab

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Public Citizen called on the Department of Health and Human Services’ (HHS’) Office of Inspector General to immediately launch a formal investigation into the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease. This close collaboration dangerously compromised the independence and objectivity of FDA senior staff and clinical reviewers who were involved in the review of Biogen’s BLA for aducanumab and key data from clinical trials of the drug.

January 11, 2021, response letter from the HHS Officer of Inspector General.

See Public Citizen’s other work on aducanumab.