Report faults FDA for ‘inappropriately’ working with Biogen on Alzheimer’s treatment

A congressional investigation found the FDA’s interactions with Biogen were “atypical and failed to follow” protocol and that the two “inappropriately collaborated” on documentation before the approval of Aduhelm for Alzheimer’s disease.

In addition, Biogen — the manufacturer of Aduhelm (aducanumab) — originally set “an unjustifiably high price” for the drug to “make history” for the company, according to the executive summary of the investigation. According to internal documents, Biogen had initially set the price of Aduhelm at $56,000 per year, “despite a lack of demonstrated clinical benefit.”

Results of the investigation were published by staffs of the U.S. House of Representatives Committee on Oversight and Reform and Committee on Energy and Commerce on Dec. 29. Energy and Commerce Committee Chair Frank Pallone Jr. (D-N.J.) released a statement on the report.

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm,” Pallone stated. “While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA. Patient safety and drug efficacy must remain at the core of our nation’s pharmaceutical regulatory review process.”

Aduhelm was granted accelerated approval from the FDA on June 7, 2021. On July 9, 2021, the FDA approved an updated broad label for the drug, which stated the treatment should be initiated for those with mild cognitive impairment or dementia. On the same day, the FDA called for a federal investigation into the approval of the Biogen treatment.

According to the congressional investigation, the FDA and Biogen engaged in at least 115 meetings, calls and email exchanges over a 12-month period. More than 40 working group meetings were held, and not all were properly documented, the report stated.

“FDA’s own internal review of the agency’s approval process for Aduhelm found that the extent of collaboration between FDA and Biogen was atypical and exceeded the norm in some respects,” according to the congressional investigation.

In addition, the report states the FDA “abruptly” changed the course of the traditional approval process, to accelerate approval of Aduhelm, after only 3 weeks of review. The agency initially considered Aduhelm under the traditional approval process used for most drugs.

According to the investigation, the shift to accelerated approval only occurred after an FDA expert council meeting on April 7, 2021, which “resulted in unfavorable feedback for Aduhelm’s traditional approval.” On April 28, 2021, the FDA informed Biogen that Aduhelm would be considered for accelerated approval.

The report also states that the FDA approved, and Biogen accepted, a broad label indication for Aduhelm despite a lack of clinical data. The agency approved Aduhelm for the treatment of “people with Alzheimer’s disease,” a much broader population than Biogen studied in its clinical trials, which included those with mild cognitive impairment and mild dementia.

In 2023, the FDA is expected to meet and discuss two other treatments for AD and related dementias. Biogen and Eisai have another Alzheimer’s treatment, lecanemab, which showed a 27% reduction in cognitive decline. Eli Lilly recently announced its treatment, donanemab, met primary and secondary endpoints in a phase 3 trial.

References:

Aduhelm investigation. https://oversight.house.gov/sites/democrats.oversight.house.gov/files/Final_Document_Packet-Biogen_UPDATED_Redacted.pdf. Published Dec. 29, 2022. Accessed Dec. 30, 2022.

FDA grants accelerated approval for Alzheimer’s drug. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug. Published June 7, 2021. Accessed Dec. 30, 2022.

Lilly shares positive donanemab data in first active comparator study in early symptomatic Alzheimer’s disease. https://investor.lilly.com/news-releases/news-release-details/lilly-shares-positive-donanemab-data-first-active-comparator. Published Nov. 30, 2022. Accessed Dec. 30, 2022.

Maloney and Pallone release staff report on review, approval and pricing of Biogen’s Alzheimer’s drug Aduhelm. https://energycommerce.house.gov/newsroom/press-releases/maloney-and-pallone-release-staff-report-on-review-approval-and-pricing-of. Published Dec. 29, 2022. Accessed Dec. 30, 2022.

The high price of Aduhelm’s approval: An investigation into FDA’s atypical review process and Biogen’s aggressive launch plans. https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf. Published Dec. 29, 2022. Accessed Dec. 30, 2022.