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# OIG Report on Accelerated Approval Due in 2023
- URL: https://www.fdaweb.com/oig-report-on-accelerated-approval-due-in-2023/
- Published: 2021-08-04T12:00:00.000Z
- Updated: 2026-09-14T17:09:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149863

The HHS Office of Inspector General (OIG) says its report assessing how FDA implements the accelerated approval pathway is expected to be issued in 2023\. In an online [notice](https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp?ref=fdaweb.com), the OIG says FDA’s recent approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s patients “raised concerns due to alleged scientific disputes within FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between FDA and the industry, and FDA’s use of the accelerated approval pathway.” The OIG review was requested by FDA acting commissioner **Janet Woodcock** in response to the concerns raised over the Aduhelm approval.

The OIG will assess the agency’s use of the accelerated approval pathway in response to these concerns, the notice says. The work plan calls for reviewing interactions between FDA and outside parties as well as other aspects of the process, such as deciding on the accelerated pathway and scientific disputes.

“We will review 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,” OIG says. “We will not assess the scientific appropriateness of FDA’s approval of any of the drugs under review.”