FDA chief tells reporter to ‘pass’ when rushed to approve Biogen Alzheimer drug

Acting Food and Drug Administration commissioner Dr Janet Woodcock on Wednesday rejected a reporter’s questions about the controversial approval of Biogen’s Alzheimer’s drug, Aduhelm.

During an interview with STAT’s Breakthrough Science Summit, STAT reporter Nicholas Florko asked Woodcock several questions about the drug, including whether she was surprised that it was approved by the agency for such wide use.

When the FDA approved Aduhelm last month, it didn’t limit its use to certain patients with Alzheimer’s disease. But after facing intense criticism, US regulators changed course about a month later, updating the label and reducing the use of the drug for people with mild or Alzheimer’s disease. at an early stage.

Woodcock said on Wednesday that the larger label was compatible with other drugs for neurodegenerative diseases. The FDA chief also acknowledged that Biogen’s drug approval process could have been handled differently.

“It is possible that the process was handled in a way that would have reduced the number of controversies involved,” she said.

Florko asked if she was surprised by the label. She replied, “I think we should 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 worked all last year for Operation Warp Speed, the drug and drug program. Covid vaccines from former President Donald Trump. She then said, “Nick, it’s an interrogation right now,” and again asked that they go to questions about the drug from the biotech company.

“I’m not going to comment on if, when and who. I really think we should 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 the inspector general to investigate interactions between the U.S. agency and Biogen ahead of the drug’s approval on June 7.

Biogen shares surged last month after the FDA approved the biotech company’s drug, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s disease and the first new drug for the disease in nearly two decades.

The move marked a break with the opinion of the agency’s group of independent experts, which unexpectedly refused to approve the drug last fall, citing unconvincing data. At least three panel members resigned in protest following the agency’s approval.

Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients, asking to speed up treatment of the drug, scientifically known as aducanumab. The drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists say plays a role in this devastating disease.

The survey is the latest setback for the company and the drug, which has been controversial since showing promise in 2016.

In March 2019, Biogen halted development of the drug after analysis by an independent group found it unlikely to work. The company then shocked investors several months later by announcing that it would ultimately seek regulatory approval for the drug.

When Biogen applied for drug approval in late 2019, its scientists said that new analysis of a larger data set showed aducanumab “reduces clinical decline in patients with Alzheimer’s disease. early “.

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some questioning whether there was enough clinical trial data to prove the drug works and whether approval could make it harder for other companies to list. of patients in their own drug trials.

Some doctors have said they will not prescribe aducanumab due to the mixed data package supporting the company’s claim.