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Letter to the FDA Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab

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Public Citizen urged the Food and Drug Administration (FDA) to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the 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. We also urged the agency not to approve the BLA for aducanumab given the clear lack of substantial evidence that the drug is effective for treating Alzheimer’s disease.

January 22, 2021, FDA response letter.

See Public Citizen’s other work on aducanumab.