STAT+: Federal watchdog raises some concerns about the FDA's accelerated approval program

A federal watchdog weighed in Tuesday on the Food and Drug Administration’s controversial accelerated approval pathway, identifying three instances where the FDA deviated from protocol during a drug approval.

The report, released by the Office of the Inspector General for the Department of Health and Human Services, intended to determine whether the FDA’s contentious approval of Biogen’s Alzheimer’s drug, Aduhelm, was the outlier or the norm. The agency approved the drug against the recommendations of an independent advisory panel. STAT later revealed that Biogen executives recruited top neurology drug regulator Billy Dunn to help secure Aduhelm’s approval.

OIG’s report suggests Aduhelm was more of an outlier, as investigators found only three troubling instances out of a sample of 24 accelerated approval drugs. But Ivan Troy, social science analyst at HHS OIG, noted even one misstep can negatively impact scores of patients.

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