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Follow-up Letter to the HHS Secretary Calling for the Resignations of Acting FDA Commissioner, Other Top Officials Responsible for Indefensible Approval of 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) Secretary Xavier Becerra to immediately request the resignations or seek the removal of the three officials most responsible for the indefensible decision to approve the drug, including Acting Commissioner Janet Woodcock. It is also imperative that the Secretary urge the HHS Office of Inspector General to immediately initiate a thorough investigation of the unprecedented and inappropriately close collaboration between the FDA and Biogen in the analysis of data from the key clinical trials of aducanumab, including the circumstances detailed in the STAT article.

See Public Citizen’s other work on aducanumab.