F.D.A. Requests 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, known as Aduhelm. She pointed to interactions between representatives from the drug’s developer, Biogen, and the agency, saying that 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.

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

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