Chairs Pallone and Maloney Issue Statement on FDA Request for HHS OIG Review of Aduhelm Approval
Today, Rep. Frank Pallone, Jr., Chairman of the Committee on Energy and Commerce, and Rep. Carolyn B. Maloney, the Chairwoman of the Committee on Oversight and Reform, issued a joint statement following news that Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock has requested the Department of Health and Human Services (HHS) Office of Inspector General (OIG) review the interactions between Biogen and FDA during the process leading to approval of Biogen’s Alzheimer’s drug Aduhelm:
“We are pleased that following the announcement of our investigation into Aduhelm’s approval process, Acting Commissioner Woodcock has asked the OIG to review this matter. We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers. An OIG review will complement our Committees’ robust investigation of this matter.”
The FDA granted Aduhelm an accelerated approval on the basis that it reduces amyloid beta plaques in the brain.
On November 6, 2020, at the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting, none of the 11 members voted to recommend approval of Aduhelm to treat Alzheimer’s disease. Following FDA’s approval of Aduhelm in June, three PCNS members resigned in protest.
Biogen has announced a list price of $56,000 per year for Aduhelm. At this price, the Kaiser Family Foundation estimates that Medicare could spend $57 billion or more per year on Aduhelm, which is more than Medicare Part B spends on all other drugs combined.