FDA Is Investigating 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, which has drawn sharp criticism from lawmakers and the medical community.

In a letter To the independent Office of the Inspector General of the Department of Health and Human Services, the FDA’s acting official, Dr. Janet Woodcock accepted the scrutiny the agency faced about the approval process for the drug, known as Aduhelm, which has a $56,000 annual price tag. Citing interactions between the drug’s developer, Biogen, and agency representatives, he said some “may have occurred outside of the formal correspondence process.”

Dr. “To the extent that these concerns may undermine public confidence in the FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” Woodcock wrote. He noted that the review would need to look into whether any communications between the agency’s staff and Biogen’s representatives violated FDA rules.

Biogen spokesperson Dana Conti said the company will “of course cooperate with any investigation connected with a possible review of the regulatory process”.

It is unusual for an institution to request an investigation into the decision-making process of its staff for an individual drug approval. The move is likely to intensify the debate surrounding Aduhelm. The FDA approved it a month ago, overriding the vehement objections of its own independent advisors and many other scientists who said there wasn’t enough evidence to know if the drug was effective.

On Thursday, the FDA moved to narrow its recommendation about who should take the medicine. After initially recommending it for all Alzheimer’s patients, the agency’s new guidelines say it should only be prescribed to people with mild cognitive problems.

One of three experts who left the FDA advisory panel last month to protest the agency’s decision on Aduhelm, Dr. Aaron Kesselheim said he welcomes the call for a federal investigation.

A professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, Dr. “It’s really important that an investigation happens publicly and quickly so that we can answer the many important questions surrounding this decision,” Kesselheim said.

A number of Alzheimer’s and public health experts have expressed concern about what they describe as an unusually close collaborative relationship between Biogen and the FDA as the drug is being reviewed. One example was the agency’s move to jointly present with Biogen its brilliant review of the evidence supporting the drug at the FDA’s meeting of independent advisors in November 2019.

Stat, medical news organization, first reported In early May 2019, the agency’s head of neuroscience, Dr. Billy Dunn, Biogen executive Dr. Had an off-the-record meeting with Al Sandrock. While it is not unusual for pharmaceutical company executives to meet with FDA officials frequently, it is unusual to present data that would be part of FDA enforcement outside of a formal setting.

A few months ago, Biogen took action to halt Aduhelm’s work in two further stages, after finding that an early analysis would not be effective. But the Biogen researchers, who analyzed the data, soon concluded that the decision to stop the studies was premature and they had reason to believe it might be effective.

Dr. Dunn and Dr. Sandrock’s May 2019 meeting was the first step to restart negotiations that led to last month’s approval. It led to the first of a series of standardized formal meetings between Biogen and agency staff. It also led to a more unusual collaboration: That summer, company and agency representatives worked closely together and communicated almost daily to sort through Biogen’s complex data from the studies, Stat reported.

Aduhelm was the first drug approved to treat Alzheimer’s in 18 years — and the first approval for a drug designed to attack the biological basis of the disease rather than just delay symptoms.


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