BioCentury
ARTICLE | Politics, Policy & Law

Woodcock acts to bolster confidence in FDA, distance herself from Aduhelm controversy

Request for OIG investigation could focus attention on staff and away from leadership

July 9, 2021 6:14 PM UTC

By requesting an independent investigation of FDA’s interactions with Biogen during the review of Aduhelm, Acting FDA Commissioner Janet Woodcock is trying to bolster public confidence in the agency’s integrity, and distance herself from a controversy that could derail her chances of being nominated as commissioner on a permanent basis. 

On Friday, Woodcock requested an independent investigation by the HHS Office of the Inspector General into whether interactions between agency officials and Biogen Inc. (NASDAQ:BIIB) employees during the review of Aduhelm aducanumab-avwa for Alzheimer’s disease “were inconsistent with FDA policies and procedures.” ...