FDA Heads Call for Investigation into Drug Review of Alzheimer’s Disease

Woodcock has requested an inspector from the Department of Health and Human Services, the oversight body that oversees the FDA and other federal health agencies. The move comes after multiple requests for approval from medical professionals, consumer advocates, and members of the House of Representatives. The two parliamentary commissions have already begun their own reviews.

“We believe that an independent assessment is the best way to determine if the interactions that occurred between the manufacturer and the review staff of the authorities were inconsistent with FDA policies and procedures,” Woodcock said. I am writing on Twitter. Biogen has promised to cooperate with the investigation.

Last month, health news site Stat reported on an unusually close collaboration between Aduhelm’s pharmaceutical company Biogen and FDA staff. In particular, the site reported an “off-the-book” meeting in May 2019 between Biogen’s top executives and the FDA’s chief reviewer for Alzheimer’s disease.

The meeting came after Biogen stopped two studies because the drug did not seem to delay the disease as intended. Biogen and the FDA have begun reanalyzing the data together, concluding that the drug may actually work. This collaboration ultimately led to conditional approval of the drug two years later, based on reducing the accumulation of sticky plaque in the brain, which is thought to be involved in Alzheimer’s disease.

Interactions between the FDA and pharmaceutical industry staff are tightly controlled and, in most cases, carefully documented. It is unclear whether the May 2019 meeting violated government rules.

When Biogen and the FDA brought the drug to the FDA’s external advisory board in November, the group almost unanimously urged the refusal.

The FDA does not have to follow the group’s advice. And the FDA’s lead staff reviewers have been working with Biogen for months on drug data, calling it “very convincing,” “very positive,” and “robust.” did.

Public Citizen, a consumer advocacy group, called for a collaborative investigation after an advisory board in November. Dr. Michael Kalom, Group Health Director, welcomed Woodcock’s request for inquiries.

“I’m glad she made this request, which should have been made a few months ago, late,” Carome said. “Since November, we have clearly seen signs of inappropriate collaboration.”

The FDA has faced a fierce backlash since approving a drug that costs $ 56,000 a year and requires monthly IV.

Three of the FDA’s advisers who opposed the drug resigned from the decision. Among other issues, the authorities have not disclosed that they are considering conditional approval of the drug based on its effects on brain plaque rather than the actual benefit to the patient. Protested. Aduhelm is the first drug for Alzheimer’s disease so approved.

Dr. Aaron Kesselheim, a Harvard researcher and one of the three resigned advisors, said: important. “

On Thursday, the FDA took the unusual step of significantly reducing prescribing information about drugs. The agency and Biogen have announced that the new label is recommended only for patients with mild or early-stage Alzheimer’s disease. This was after many doctors criticized the original label as being too wide. He said that anyone with Alzheimer’s disease could be given the drug.

Aduhelm has not been shown to reverse or significantly delay the disease. However, the FDA said its ability to reduce plaque mass in the brain is likely to delay dementia. Over 20 other drugs have previously tried that approach with no positive results. Biogen needs to carry out follow-up to clearly answer whether it actually works. Other Alzheimer’s disease medications only temporarily relieve symptoms.

Woodcock has been an agency commissioner since January. Previously, she spent more than 25 years directing the agency’s drug center. While widely respected by the government and the pharmaceutical industry, she has also been criticized for actively promoting the approval of new treatments, even if the effects are uncertain.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.