FDA wants investigation into Biogen drug approval
United States Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock on Friday requested an investigation into the approval of Biogen Inc.’s Aduhelm (aducanumab) treatment for Alzheimer’s disease.
She asked that the Office of Inspector General at the US Department of Health and Human Services conduct an independent probe into “interactions between representatives of Biogen and the FDA during the process leading to the decision to approve the BLA [biologics license application].”
The approval of the drug caused significant controversy due to its price and questions about its effectiveness, reports of unofficial meetings between the company and FDA representatives, and the regulatory process that was reportedly expedited without clear justification.
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