By Ahmed Abu El-Enein

A congressional report showed that the FDA failed to adhere to its internal guidelines and practices during the approval process for Biogen’s (NASDAQ:) Alzheimer’s drug, which was “riddled with irregularities.” Thursday.

The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a task force report on the results of an 18-month investigation by two House committees into the drug’s regulatory review, approval, pricing, and marketing.

The U.S. Food and Drug Administration approved Aduhelm in June 2021 under the fast-track approval track over the objections of a panel of outside advisors, who did not believe that the data definitively demonstrated the drug’s benefit for patients.

It was licensed based on evidence that it could reduce brain plaques, a possible contributor to Alzheimer’s disease, rather than on proof that it slowed the progression of the potentially fatal loss-of-mind disease.

Medicare has restricted its coverage, which has resulted in very limited use of the Biogen drug.

The report said Biogen set an “unjustifiably high” price by initially pricing Aduhelm at $56,000 per year despite a lack of proven clinical benefit in a large number of patients, adding that the company’s internal projections showed it expected the drug to be a burden to Medicare. expensive for patients.

“The findings in this report raise serious concerns about FDA loopholes in the protocol and Biogen’s disregard for efficacy and access in the approval process for Aduhelm,” the report, which was prepared by staff from the House Committee on Oversight and Reform and the House Committee on Energy and Commerce, concluded.

The report recommended that the agency should ensure that all substantive interactions with drug sponsors are properly memorialized, establish a protocol for joint briefing documents with drug sponsors, update industry guidance on developments and review new Alzheimer’s drugs.

The report said Biogen and other drugmakers should report any safety and efficacy concerns to the FDA, as well as take value and patient access into account when setting prices.

An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on scientific evaluation of the data in the app.

He cited the Food and Drug Administration’s internal review which found its employees’ interactions with Biogen appropriate.

“It is the agency’s mission to interact frequently with companies in order to ensure that we have sufficient information to inform our regulatory decision-making. And we will continue to do so, because it is in the best interest of patients,” he said, adding that the agency will continue to use the expedited approval pathway whenever appropriate.

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

“Biogen stands by the integrity of the actions we have taken,” the Cambridge, Massachusetts-based biotechnology company said in an emailed statement.

As stated in the congressional report, the (FDA) review concluded that “there is no evidence that these interactions with the sponsor prior to submission were inappropriate in this situation.”

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

The total number of meetings is unknown because the FDA failed to keep a clear record of informal meetings and interactions between its employees and Biogen representatives. The investigation identified 66 additional calls and email exchanges that were not immortalized.

The report said the FDA improperly collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, with FDA and Biogen staff working closely for several months prior to the November 6, 2020 meeting to prepare the document. , which failed to adequately represent the different viewpoints within the agency.

Using a joint briefing document that gave Biogen advance insight into the FDA’s responses and direct guidance from the agency in drafting the company’s own sections. For example, in an exchange of a draft briefing document on October 9, 2020, FDA staff asked Biogen to convey a paragraph drafted by the agency. in the Biogen section of the memo – a change reflected when the document was completed, the report to the media organizations said.

When none of the advisory committee members voted to approve Aduhelm, the FDA focused on using the accelerated approval path — typically used for rare diseases or small patient groups that lack access to effective treatments — despite considering the drug under the traditional approval path. For nine, the report said.

It did so according to a greatly abbreviated timeline, approved it after three weeks of review, and for a broad reference to “people with Alzheimer’s disease” not supported by clinical data, the report said.

Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations that there was no evidence Aduhelm could help patients in disease stages outside of clinical trials.