FDA calls for federal investigation into Aduhelm's approval

Janet Woodcock, MD, the FDA's acting commissioner, said July 9 that she requested the HHS' Office of Inspector General conduct an independent review of the correspondence that took place between the FDA and Biogen during Aduhelm's approval process.

The announcement, made via Dr. Woodcock's Twitter page, came a month after the drug's approval. 

Aduhelm, which was approved June 7 using the FDA's accelerated approval pathway, was the first Alzheimer's treatment approved by the FDA since 2003. It is the first treatment approved by the FDA to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA has previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression. 

The approval sparked an intense debate in the pharmaceutical and medical communities, with critics saying there was not enough evidence of clinical benefits to warrant an approval. Three members of the FDA's advisory committee resigned over the approval, and two House committees are investigating the drug's pricing and approval.

"We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures," Dr. Woodcock wrote on Twitter.

If HHS chooses to conduct the investigation, Dr. Woodcock said the FDA will "fully cooperate" and review their recommendations.

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


Featured Whitepapers

Featured Webinars