A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021.
Adam Glanzman | Bloomberg | Getty Images
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 FDA approved Aduhelm last month, it did not restrict its use to specific Alzheimer’s patients. But 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 FDA chief also acknowledged that the approval process of Biogen’s drug could have potentially been handled differently.
“It’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved,” she said.
Florko asked whether she was surprised about the 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 all last year for Operation Warp Speed, former President Donald Trump’s Covid drug and vaccine program. She then said, “Nick, this is an interrogation right now,” and asked again that they move on from questions about the biotech company’s drug.
“I’m not going to comment on if and when and who. I really think we ought to move on,” she replied.
The interview came less than a week after Woodcock called for a federal investigation into the approval of Biogen’s drug. On Friday, she asked the independent Office of Inspector General to investigate interactions between the U.S. agency and Biogen prior to the drug’s approval on June 7.
Biogen’s stock surged last month after the FDA 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.
That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.
Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. The drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.
The investigation is the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.
In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.
When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”
Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.
Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.