HHS will review FDA's approval of Biogen's Aduhelm

The HHS Office of Inspector General said Aug. 4 it will review the FDA's approval process for Biogen's Alzheimer's drug Aduhelm. 

The watchdog said it will assess how the FDA implements the accelerated approval pathway — which the agency used to approve Aduhelm — by reviewing interactions between the FDA and outside parties, as well as other aspects of the process. 

The inspector general "will review the FDA's relevant policies and procedures, determine compliance with them and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm," the agency said. 

It clarified that it will not assess the scientific appropriateness of the drug's approval. 

The agency said it will issue a report by 2023. 

Acting FDA Commissioner Janet Woodcock, MD, asked the inspector general's office to review the FDA's approval process in July. In a series of tweets posted Aug. 4, she said the FDA intends to "fully cooperate" with the review and "welcomes the opportunity to provide clarity regarding the science-based application of the accelerated approval pathway." 

"We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible. Should the HHS OIG identify any actionable items and provide the agency with any recommendations, the FDA would review those expeditiously to determine the best course of action," Dr. Woodcock tweeted. 

The FDA's decision to approve the drug June 7 has been met with a wave of criticism and allegations of an "inappropriately close relationship" between the FDA and the pharmaceutical industry, the inspector general said. 

Documents released by the FDA June 22 show the agency'sstatisticians and advisers repeatedly objected to the drug's approval. 

Several health systems, including the Cleveland Clinic, Providence in Renton, Wash., and Mount Sinai in New York City, have said they won't administer Aduhelm, at least until more data on the drug's efficacy is released. 

Physicians at Harvard Medical School in Boston and the Mayo Clinic in Rochester, Minn., as well as other members of an FDA committee that voted not to approve Aduhelm, penned an op-ed in The New England Journal of Medicine July 28 slamming the FDA's decision to approve the drug. 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars