Congressional inquiry into 'highly atypical' FDA-Biogen ties ends with damning report, no repercussions
The FDA’s controversial approval of Biogen’s amyloid-targeted Alzheimer’s drug Aduhelm was “highly atypical” and “deviated” from FDA’s standard practices “in significant respects,” two key congressional committees late last week said in a report following an 18-month investigation into what transpired.
While the cozy ties that contributed to the approval, as revealed in this new report, may look like a slap in the face for both Biogen and FDA, at the end of the day the report offers a roadmap for how other companies may leverage behind-the-scenes interactions with FDA leaders to their advantage, and neither Biogen nor the FDA will face any consequences for their actions, at least as part of this investigation. The SEC, FTC and HHS’ OIG inquiries are still probing what happened.
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