What did Congress find about the relationship between Biogen and the FDA?
FDA staff and Biogen had at least 115 informal exchanges over 12 months, jointly prepared a briefing document for the advisory committee, and Biogen planned to spend more than $3.3 billion marketing Aduhelm — findings the FDA's own internal review called atypical.
The House Oversight and Energy and Commerce committees' 18-month investigation found that FDA staff and Biogen had at least 115 meetings, calls and substantive email exchanges over 12 months beginning July 2019, many not properly documented. The two jointly prepared a briefing document for the advisory committee, which the report said gave Biogen advance insight into the FDA's responses. The FDA's own internal review had found the collaboration atypical and exceeding the norm in some respects. The committees also disclosed Biogen's plan to spend more than $3.3 billion marketing Aduhelm from 2020 to 2024. Biogen said it stood by the integrity of its actions, and FDA Commissioner Robert Califf remarked there were "no surprises in the report".