STAT+: Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
The federal watchdog at the Department of Health and Human Services will review the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen, which has caused unprecedented controversy over regulatory standards.
Specifically, the HHS Office of Inspector General will examine the accelerated approval pathway that the FDA increasingly uses to speed approvals for medicines to treat serious conditions and fill an unmet medical need. This was the pathway used by the agency two months ago when it okayed the Aduhelm treatment for Alzheimer’s.
