U.S. health officials’ approval process for Biogen Inc.’s controversial Alzheimer’s drug was “rife with irregularities,” raising serious concerns about protocol lapses at the agency, congressional investigators said.
The Food and Drug Administration collaborated excessively with Biogen while assessing the drug, called Aduhelm, according to the report on an 18-month investigation published Thursday by two House committees, Oversight and Reform and Energy and Commerce.
Aduhelm was cleared despite objections from a group of outside medical experts who advised the FDA not to allow the drug on the market, citing conflicting results from trials of its efficacy; three members of that panel resigned after the approval. The U.S. Medicare program later heavily restricted payment for Aduhelm, and Biogen stopped its marketing efforts.
