A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts on Monday, June 7, 2021.
Adam Glanzman | Bloomberg | Getty Images
Acting Commissioner of the Food and Drug Administration, Dr. Janet Woodcock, on Wednesday, turned down a journalist’s questions about the controversial approval of Biogen’s Alzheimer’s drug 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 that the agency approved it for such widespread use.
When the FDA approved Aduhelm last month, it didn’t limit its use to specific Alzheimer’s patients. But after facing heavy criticism, about a month later, U.S. regulators changed course, updated the label, and restricted use of the drug for people with mild or early-stage Alzheimer’s disease.
Woodcock said Wednesday that the broader label is in line with other drugs for neurodegenerative disease. The FDA chief also admitted that Biogen’s drug approval process could possibly have been handled differently.
“It is possible that the process would have been managed in a way that would have reduced the controversy associated with it,” she said.
Florko asked if she was surprised at the label. She replied, “I think we should go ahead.”
Then, when Florko urged Woodcock to see if she was aware of a reported meeting between an FDA regulator and Biogen in 2019, Woodcock said she had worked for Operation Warp Speed, the company’s Covid drug and vaccine program, all last year former President Donald Trump. Then she said, “Nick, this is an interrogation right now,” and asked again to move on from the biotech company’s drug questions.
“I will not comment if and when and who. I really think we should go ahead, ”she replied.
The interview came less than a week after Woodcock requested 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 US agency and Biogen prior to the drug’s approval on June 7th.
Biogen’s stock rose last month after the FDA approved the biotech company’s drug, the first drug approved by U.S. regulators to slow cognitive decline in people with Alzheimer’s, and the first new drug against the disease for nearly two decades.
This decision was a departure from the recommendations of the agency’s independent panel of external experts, which unexpectedly refused to approve the drug last fall, citing inconclusive data. At least three members of the committee resigned in protest after the agency’s approval.
Federal agencies have faced heavy pressure from friends and family of Alzheimer’s patients to ask for the drug scientifically known as aducanumab to be expedited. The drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease.
The investigation is the most recent setback for the company and the drug, which has been controversial since 2016.
In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. The company then shocked investors a few months later by announcing that it would apply for regulatory approval for the drug after all.
When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”
Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult 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 that supports the company’s application.