House Committee says FDA interactions with Biogen’ failed to follow’ protocol

The House Committee on Oversight and Reform and Committee on Energy and Commerce presented the findings of an 18-month investigation into the regulatory review and approval, pricing, and marketing of Biogen’s Alzheimer’s disease drug Aduhelm. The Food and Drug Administration granted accelerated approval for Aduhelm on the basis that the drug reduces amyloid beta plaque in the brain. The FDA’s action "came despite the fact that Biogen cancelled clinical trials for Aduhelm in March 2019 due to an independent report indicating the drug was unlikely to effectively slow cognitive and functional impairment and that further clinical study would be futile," the report says. New evidence obtained by the committees shows that an FDA-Biogen working group "engaged in at least 115 meetings, calls, and substantive email discussions over the course of a year, from July 2019 to July 2020, including convening more than 40 meetings to guide Aduhelm’s potential approval." The report claims the FDA’s interactions with Biogen "were atypical and failed to follow the agency’s own documentation protocol." The FDA and Biogen "inappropriately collaborated on a joint briefing document or the PCNS Advisory Committee that did not adequately represent differing views within FDA," the report adds. It also says Biogen set an "unjustifiably high price" for Aduhelm. Reference Link