FDA’s Approval of Biogen Alzheimer’s Drug Slammed in Report
- Congressional report follows an 18-month investigation
- FDA collaborated excessively with drugmaker, report finds
The Biogen Inc. office in Cambridge, Massachusetts.
Photographer: Adam Glanzman/BloombergThis article is for subscribers only.
US 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.