Pharmaceutical Executive February 9, 2023
Probe targets agency’s role in advising on drug testing and submissions.
A detailed report from key House Committees blasts FDA’s role advising, assessing, and providing accelerated approval in 2021 for Biogen’s controversial Alzheimer’s disease treatment Aduhelm (aducanumab). The critique calls for changes in agency interactions with manufacturers to more carefully document meetings and other communications and to clarify the agency’s role in advising sponsors on product testing and submissions.
The joint investigation by the House Energy & Commerce Committee and the House Committee on Oversight & Reform on FDA approval of Aduhelm slams FDA officials for failing to record multiple interactions with the company, particularly their assistance in developing Biogen’s briefing documents for a key advisory committee meeting. The Democrat-led...
Today's Sponsors
Today's Sponsor