F.D.A. Seeks Investigation of Its Own Alzheimer’s Drug Approval


The Food and Drug Administration on Friday called for a federal investigation of the process that led to the approval of a new drug for Alzheimer’s disease that has spurred sharp criticism from lawmakers and the medical community.

In a letter to the Department of Health and Human Services’ independent Office of the Inspector General, the F.D.A.’s acting commissioner, Dr. Janet Woodcock, acknowledged the scrutiny the agency has faced about the approval process for the drug, which is known as Aduhelm and has a $56,000 annual price tag. She pointed to interactions between representatives from the drug’s developer, Biogen, and the agency, saying some “may have occurred outside of the formal correspondence process.”

“To the extent these concerns could undermine the public’s confidence in F.D.A.’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” Dr. Woodcock wrote. She noted that the review should look at whether any of the communication between the agency’s staff and Biogen’s representatives violated F.D.A. rules.

Dana Conti, a spokesman for Biogen, said the company “will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process.”

It is unusual for the agency to request an investigation into its own staff’s decision-making process for an individual drug approval. The move is likely to intensify the controversy that has surrounded Aduhelm. The F.D.A. approved it a month ago, overriding the fierce objections of its own independent advisers and many other scientists, who said there was insufficient evidence to know whether the drug was effective.

On Thursday, the F.D.A. moved to narrow its recommendation about who should receive the drug. After originally recommending it for all Alzheimer’s patients, the agency’s new guidelines say it should be prescribed only to people with mild cognitive problems.

Dr. Aaron Kesselheim, one of three experts who quit an F.D.A. advisory panel last month in protest of the agency’s decision on Aduhelm, said he welcomed the call for a federal investigation.

“It’s really important that an investigation happen publicly and quickly so that we find answers to some of the many outstanding questions swirling around this decision,” said Dr. Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital.

A number of Alzheimer’s and public health experts have raised concerns about what they characterized as an unusually close collaborative relationship between Biogen and the F.D.A. while the drug was being reviewed. One example was the agency’s move to jointly present with Biogen its glowing review of the evidence supporting the drug in a meeting of the F.D.A.’s independent advisers in November 2019.



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