Exhibit 099 · Oversight report
How FDA used its accelerated approval pathway raised concerns in 3 of 24 drugs reviewed (OEI-01-21-00400)
This review focused on a sample of 24 drugs that went through the accelerated approval pathway; it is not a compliance review. We did not independently assess the appropriateness of the decisions made by FDA.
Reviewed 24 accelerated approvals, ten selected purposively and fourteen at random. Found unplanned analyses, internal disagreements or incomplete meeting documentation in three: aducanumab, hydroxyprogesterone caproate and eteplirsen. OIG stated the work was not a compliance review and did not independently judge the appropriateness of FDA's decisions. The recommendation tracker records on 18 May 2026 that the documentation recommendation was implemented and the recommendation on council referral criteria was not.
- Source
- U.S. Department of Health and Human Services, Office of Inspector General
- Date
- 2025
- Quoted from
- OEI-01-21-00400 (January 2025), Background, Methodology (printed pp. 7-8)
- Grade
- Primary record
- Document
- https://www.oig.hhs.gov/documents/evaluation/10160/OEI-01-21-00400.pdf
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Summary page and recommendation tracker: https://www.oig.hhs.gov/reports/all/2025/how-fda-used-its-accelerated-approval-pathway-raised-concerns-in-3-of-24-drugs-reviewed/ (methodology at printed pp. 7–9).