STAT+: Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
A federal watchdog is being asked to investigate the Food and Drug Administration for an “inappropriate collaboration” with Biogen (BIIB) in readying an application for regulatory approval to market aducanumab, its controversial Alzheimer’s treatment.
In a scathing letter to the Office of Inspector General at the Department of Health and Human Services, the advocacy group Public Citizen accused the FDA of “unbridled enthusiasm” for the medicine and for pursuing “unprecedented” cooperation with the biotech company, which has “dangerously compromised the independence and objectivity” of FDA senior staff and clinical reviewers.
