Janet Woodcock calls for independent investigation into Biogen and FDA relationships in unprecedented move
In the latest stunning chapter of the Biogen Aduhelm saga, acting FDA commissioner Janet Woodcock is calling for an investigation into the relationships between agency officials and Biogen executives.
Woodcock announced the move early Friday afternoon, posting a letter to the acting HHS Inspector General on Twitter.
Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm. pic.twitter.com/iWJNxdZ5Cs
— Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021
The request comes as controversy continues to swirl around the approval, with prominent members of Congress launching probes and Biogen taking the extraordinary step this week to ask for a narrower drug label. Woodcock’s call for a probe also comes less than two weeks after a report from STAT News highlighted a major undertaking from Biogen to get Aduhelm approved that began as early as 2019.
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