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US FDA broke its own protocols in approving Biogen Alzheimer’s drug



© Reuters. FILE PHOTO: Signage marks a Biogen facility in Cambridge, Massachusetts, U.S., March 9, 2020. REUTERS/Brian Snyder/File Photo

By Ahmed Aboulenein

WASHINGTON (Reuters) – The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during its approval process for Biogen (NASDAQ:) Alzheimer’s drug Aduhelm, “full of rife with irregularities,” a congressional report showed on Thursday.

FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House committees into evaluation, approval, pricing and regulation of drugs. marketing.

The FDA approved Aduhelm in June 2021 under an expedited approval route in the face of objections from an external advisory panel, who did not believe the data clearly demonstrated the drug’s benefit to patients.

It is licensed based on evidence that it can reduce plaque in the brain, a likely cause of Alzheimer’s disease, rather than evidence that it slows the progression of the mind-wasting disease. deadly brain.

The Medicare program has limited its coverage, resulting in severely limited use of the drug Biogen.

Biogen has set the price “unreasonably high” by setting the initial price of Aduhelm at $56,000 per year despite a lack of proven clinical benefit for many patients, the report said. adds that the company’s own internal projections suggest it views the drug as a burden on Medicare and costly to patients.

“The findings in this report raise serious concerns about FDA protocol flaws and Biogen’s disregard for effectiveness and accessibility in the Aduhelm approval process,” the report, which was approved prepared by the staff of the House Oversight and Reform Committees and the House Energy Committee. Trade, conclusion.

The agency should ensure that all substantive interactions with drug donors are properly remembered, establish a protocol for joint summary documents with drug donors, and update industry guidance. on the development and evaluation of new Alzheimer’s disease drugs, the report recommends.

The report said Biogen and other drug makers should notify the FDA of any safety and efficacy concerns and consider value and patient access when pricing.

An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on a scientific review of the data contained in the application.

He pointed out that the FDA’s internal review found the employee’s interaction with Biogen to be appropriate.

“It is the duty of the agency to regularly interact with companies to ensure that we have sufficient information to make regulatory decisions. We will continue to do so because it is in our best interest to do so. of the patient,” he added. that the agency will continue to use the expedited approval route whenever appropriate.

The spokesperson said the FDA has already begun implementing some of the report’s recommendations.

Biotech company based in Cambridge, Mass.

“As stated in the congressional report, a review by the (FDA) concluded that, ‘There is no evidence that these pre-application donor interactions are anything but appropriate in this situation’,” said Biogen.

Documents obtained by the committees show that FDA and Biogen staff held at least 115 meetings, calls, and email exchanges over a 12-month period as of July 2019.

The total number of meetings is not known because FDA does not keep clear records of meetings and informal interactions between its employees and Biogen representatives. The investigation identified 66 additional calls and email exchanges that were not remembered.

The report states that the FDA improperly collaborated with Biogen in a joint summary document for the Central and Peripheral Nervous System (PCS) Advisory Committee, with FDA and Biogen staff working closely. closely in the months leading up to the November 6, 2020 meeting to prepare the document, did not fully represent the differing views within the agency.

“Using the generic summary document helps Biogen better understand FDA responses and direct guidance from the agency in drafting its own sections. For example, in a document exchange. the draft summary on October 9, 2020, FDA staff asked Biogen to move an agency-drafted passage into Biogen’s section of the memo — a change that was reflected as the document was finalized,” Reports are made available to media organizations.

When no member of the advisory board voted to approve Aduhelm, the FDA turned to an expedited approval route—typically used for rare diseases or small groups of patients without access to alternative treatments. effective treatment – despite looking at the drug under the traditional nine-year approval route. month, the report said.

It did so on a dramatically shortened timeline, approving it after three weeks of review and giving a broad label indication of “people with Alzheimer’s disease” not supported by clinical data, reports said.

Internal documents obtained from the investigation suggest that Biogen accepted the indication despite its own reservations about the lack of evidence Aduhelm can help patients at disease stages outside of clinical trials. ready.

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