A congressional investigation found that the U.S. Food and Drug Administration did not follow its own guidance and inappropriately collaborated with drugmaker Biogen before the approval of a controversial Alzheimer’s drug last year, CNN reported.
The 18-month-long investigation found the FDA’s “atypical collaboration” to approve a high-priced Alzheimer’s drug was “rife with irregularities.”
A joint report was released Thursday by two House committees, the Energy and Commerce and Oversight and Reform panels.
The report said the FDA and Aduhelm manufacturer Biogen inappropriately collaborated and failed to follow the agency’s process for documenting the meetings. The agency then allowed Aduhelm to be granted accelerated approval.
The report says Biogen set an “unjustifiably high price” for Aduhelm to “make history” for the company, and thought of the drug as an “unprecedented financial opportunity.”
Biogen priced Aduhelm at $56,000 per year, even though its actual effects on a broad patient population were unknown, The Hill reported.
It matters because the findings come as the FDA reviews two other Alzheimer’s drugs that target proteins believed to contribute to the development of Alzheimer’s.
While effective new treatments could deliver new hope to millions with the devastating condition, they also raise major questions about who’ll pay the costs and how the U.S. will oversee what could become a multi-billion-dollar market.
More than 6.5 million people in the U.S. live with Alzheimer’s, and that number is expected to grow to 13.8 million by 2060.
The disease is the sixth leading cause of death in the United States.
There is no cure, and effective treatments are extremely limited. Before Aduhelm’s approval in June 2021, the FDA had not approved a novel therapy for the condition since 2003.
The FDA’s decision to approve Aduhelm was based on thin evidence, with the FDA’s own staff saying it didn’t meet the agency’s customary standards. An outside advisory committee of experts recommended approving the drug.