Reacting to public criticism of the U.S. Food and Drug Administration’s (FDA’s) accelerated approval of Alzheimer’s disease treatment Aduhelm, the U.S. Department of Health and Human Services (HHS) recently announced its Office of Inspector General will conduct an independent study of the drug’s approval process.
“The FDA’s approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA’s use of the accelerated approval pathway,” HHS noted. “In response to these concerns, we will assess how the FDA implements the accelerated approval pathway. This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes.”
HHS 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. It will not assess the scientific appropriateness of the FDA’s approval of any of the drugs under review.
This work may result in multiple reports, the first of which is likely to be released in 2023, according to HHS.
Edited by Michael Causey