Food and Drug Administration Asked Journalist to Move On

Acting Food and Drug Administration Commissioner Dr Janet Woodcock on Wednesday pushed back against questions from a journalist about the controversial approval of Biogen’s Alzheimer’s medication, Aduhelm.During an interview at STAT’s Breakthrough Science Summit, STAT reporter Nicholas Florko asked Woodcock several questions about the drug, including whether she was surprised it was approved by the agency for such broad use.

When the Food and Drug Administration approved Aduhelm last month, it did not restrict its use to specific Alzheimer’s patients. After facing intense criticism, U.S. regulators changed course about a month later, updating the label and narrowing the drug’s use for people with mild or early-stage Alzheimer’s.

Woodcock said Wednesday that the broader label was consistent with other drugs for neurodegenerative diseases. The Food and Drug Administration chief also acknowledged that the approval process of Biogen’s drug could have potentially been handled differently. She said that it is possible that the process could have been handled in a way that would have decreased the amount of controversy involved. Florko asked whether she was surprised about the label. She replied that she thought we ought to move on.

When Florko then pressed Woodcock if she was aware of a reported meeting between an Food and Drug Administration regulator and Biogen in 2019, Woodcock said she was working all last year for Operation Warp Speed, former President Donald Trump’s Covid drug and vaccine program. She said, Nick, this is an interrogation right now, and asked again that they move on from questions about the biotech company’s drug.Biogen’s stock surged last month after the approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.