A House committee report said the Food and Drug Administration did not follow proper guidance when approving Biogen’s Alzheimer’s drug. File Photo by CJ Gunther/EPA-EFE
Dec. 29 (UPI) — The U.S. Food and Drug Administration’s approval process for Biogen’s Alzheimer’s drug was “rife with irregularities,” a congressional report released Thursday said.
The agency did not adhere to its own guidance and its interactions with the company did not follow documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House committees into the drug’s regulatory review, approval, pricing and marketing.
The drug, Aduhelm, was approved in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug’s benefit to patients.
Aduhelm’s price was initially set at $56,000 per year despite a demonstrated lack of clinical benefit in a broad population. Biogen later halved its annual price to $28,800.
The company’s internal projections showed that it expected the drug to be a burden to Medicare, which had restricted its coverage of the drug.
“The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.
An FDA spokesperson told NBC News that the FDA’s decision to approve Aduhelm was based on scientific evaluation of the data contained in the application.
He pointed to the FDA’s internal review finding its staff’s interactions with Biogen appropriate.
“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients,” he said, adding that the agency will continue to use the accelerated approval pathway whenever appropriate.
FDA staff members and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting in July 2019, according to documents. The total number of meetings is unknown because the FDA did not keep a record of informal ones.
The agency then approved the drug on a substantially abbreviated timeline, after just three weeks of review.
