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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