via abcnews:
A congressional investigation into the Food and Drug Administration’s review process for an Alzheimer’s treatment found that the agency “deviated” from its standard procedures to approve the Aduhelm drug with inconsistent data.
Aduhelm is notable for being the first drug in recent years approved to treat the underlying cause of Alzheimer’s, a disease with no known cure that is characterized by progressive dementia that affects more than six million Americans, according to the Alzheimer’s Association.
The joint 18-month investigation between the House’s Oversight and Reform Committee and Energy and Commerce Committee, released on Thursday, criticizes the FDA for “atypical collaboration and interactions” with Biogen, the drug’s manufacturer.
In statements, Biogen and the FDA both said their interactions prior to Aduhelm’s green light were appropriate in the context of the approval process.
“One of my top priorities as Chair of the Committee on Oversight and Reform is ensuring that the American people have access to effective and affordable medications,” Rep. Carolyn Maloney, D-N.Y., chairwoman of the House Oversight and Reform Committee, said in a statement.
h/t Glenn