Woodcock Requests Independent Review Of Biogen-FDA Aduhelm Interaction … Not Approval Decision

 
• By Sarah Karlin-Smith

US FDA Acting Commissioner’s request for an HHS OIG review related to the Alzherimer’s drug approval is fairly narrow and continues to frustrate critics who believe the drug should not be approved. Woodcock expressed confidence in the CDER team in the letter to OIG, framing the investigation request as a move to help ensure public trust in the FDA.

An OIG investigation would put Biogen and FDA’s relationship under a magnifying glass. • Source: Alamy

US Food and Drug Administration Acting Commissioner Janet Woodcock requested 9 July an independent review and assessment of the agency and Biogen, Inc.’s interactions during the lead up to the approval of Biogen’s Alzheimer’s treatment Aduhelm (aducanumab-avwa) to determine whether any interactions “were inconsistent with FDA policies and procedures.”

The move marks the second time this week the agency has taken steps to try and address the blowback it has received following the controversial accelerated approval on 7 June

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