Exhibit 097 · Oversight report
Delays in confirmatory trials for drug applications granted FDA's accelerated approval raise concerns
Of those 104, 34 percent (35 of 104) have at least one trial past its original planned completion date.
Identified 278 accelerated approval applications through December 2021. Of 104 with incomplete confirmatory trials, 35 had at least one trial past its original planned completion date, with trial status as of 5 May 2022. Medicare and Medicaid spent more than $18 billion from 2018 to 2021 on the 18 drugs corresponding to those 35 applications. The figure is total spending on those drugs, not spending after deadlines or proven waste.
- Source
- U.S. Department of Health and Human Services, Office of Inspector General
- Date
- 2022
- Quoted from
- OIG report page (OEI-01-21-00401), 'What we found', paragraph 1
- Grade
- Primary record
- Document
- https://oig.hhs.gov/reports/all/2022/delays-in-confirmatory-trials-for-drug-applications-granted-fdas-accelerated-approval-raise-concerns/
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Further quotation: “Of all 278 drug applications granted accelerated approval, 104 have incomplete confirmatory trials.” (HHS-OIG report page, 'What We Found'; the page gives 'Issued on 09/29/2022 | Posted on 09/29/2022 | Report number: OEI-01-21-00401'). Same paragraph: 'Furthermore, since the inception of the pathway, 13 percent of all accelerated approval drug applications have been withdrawn, half of which were withdrawn since January 2021.' The OIG full-report PDF (oig.hhs.gov/documents/evaluation/10120/OEI-01-21-00401.pdf) did not load; only the report web page was read.