Exhibit 128 ยท Inspector general evaluation
How FDA Used Its Accelerated Approval Pathway Raised Concerns in 3 of 24 Drugs Reviewed (OEI-01-21-00400)
Removing HPC from the market took 3 years, during which time patients had access to and were paying for the drug.
Reviewed 24 of the 278 drugs CDER approved through accelerated approval from 1992 through December 2021: 10 chosen purposively as approvals stakeholders called concerning, 14 at random. Found concerns in three (aducanumab, hydroxyprogesterone caproate and eteplirsen): analyses outside the sponsor's original plan, approval over objections from FDA reviewers or advisory committees, and incompletely documented sponsor meetings. Two of the three left the market and the third's confirmatory trial, due in 2021, is delayed. States that it is not a compliance review and did not assess the appropriateness of FDA's decisions. Summarizes the 2022 companion report (OEI-01-21-00401): more than one-third of accelerated approval applications with incomplete confirmatory trials were past their planned completion dates, and Medicare and Medicaid spent more than $18 billion from 2018 to 2021 on such drugs. FDA concurred with the documentation recommendation and did not concur with the recommendation to define when its accelerated approval council must advise.
- Source
- U.S. Department of Health and Human Services, Office of Inspector General
- Date
- January 2025
- Quoted from
- Findings, printed p. 16 (PDF p. 18)
- 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
- OIG's 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/) recorded closure on 18 May 2026: the documentation recommendation implemented, the council recommendation not.