The FDA failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was 'rife with irregularities,' a congressional report showed.
WASHINGTON - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday.
It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer's, rather than proof that it slowed progression of the lethal mind-wasting disease. "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.
"As stated in the congressional report, an review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'" Biogen said. The FDA inappropriately collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System Advisory Committee, the report said, with FDA and Biogen staff working closely for months ahead of the Nov. 6, 2020 meeting to prepare the document, which failed to adequately represent differing views within the agency.
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