Benzinga | Jul 15, 2021 10:51AM EDT

Biogen's Alzheimer's Drug Aduhelm Review Could Have Been Handled Differently, Says FDA Chief: STAT News

* Acting FDA Commissioner Janet Woodcock pushed back against media questions about the agency's controversial approval of Alzheimer's treatment, Aduhelm developed by Biogen Inc (NASDAQ:BIIB) and Eisai Co Ltd (OTC:ESALY).

* During an interview at STAT's Breakthrough Science Summit, STAT journalist Nicholas Florko asked whether she was surprised about the broad label. She replied, "I think we ought to move on."

* When Florko then pressed Woodcock if she was aware of a reported meeting between an FDA regulator and Biogen in 2019, Woodcock said she was working for Operation Warp Speed. She then said, "Nick, this is an interrogation right now."

* During the interview, Woodcock also acknowledged that the approval process of Biogen's drug could have potentially been handled differently, which could have decreased the controversy.

* The FDA's approval of Aduhelm has been in the headlines since last month. The agency had to narrow the label to recommend the use of Aduhelm in mild Alzheimer's patients.

* Last week, Woodcock called for a federal investigation into the approval of Aduhelm.

* Centers for Medicare & Medicaid Services also started the review process for national Medicare coverage of the drug.

* Price Action: BIIB shares are down 5.85% at $331.28, and ESALY shares are down 1.7% at $95.74 during the market session on the last check Thursday.