What did the congressional investigation into Aduhelm find?
FDA staff and Biogen had at least 115 informal meetings during the review, jointly prepared a briefing document for the advisory committee, and the agency's own statistical team had argued the evidence was insufficient.
Two House committees reviewed more than 500,000 FDA and Biogen documents and concluded in December 2022 that the review was rife with irregularities. They found FDA staff and Biogen had at least 115 meetings, calls and substantive email exchanges over 12 months, often without a clear record, and had jointly prepared a briefing document for the advisory committee, giving Biogen advance insight into the agency's thinking.
Such joint documents had been used only nine times before, and the FDA's own statistical team had argued the evidence of benefit was insufficient. The approval also came even though Biogen had halted its trials in March 2019 after an independent analysis judged them futile. Biogen responded that an FDA internal review had found no evidence the interactions were inappropriate.