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# OIG Hit FDA Accelerated Approvals
- URL: https://www.fdaweb.com/oig-hit-fda-accelerated-approvals/
- Published: 2025-06-17T12:00:00.000Z
- Updated: 2026-09-14T15:14:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159372

The HHS Office of Inspector General (OIG) semiannual report covering the period 10/1/2024 to 3/31 says the OIG concluded that FDA’s use of its accelerated approval pathway raised concerns in three of 24 drugs reviewed. The [report](https://oig.hhs.gov/documents/sar/10324/Spring%5F2025%5FSAR%5F508.pdf?ref=fdaweb.com) says OIG [identified instances](https://www.fdaweb.com/oig-faults-3-of-24-fda-accelerated-approvals/) in which FDA **(1)** approved drugs despite concerns from its reviewers and/or advisory panels; **(2)** deviated from recommended practices by evaluating analyses not included in the sponsor’s original plan; and **(3)** did not properly document meetings held during the review process.

“Two of the three drugs that raised concerns are now off the market,” the report says, “and completion of the confirmatory trial for the third drug has been delayed.”

The report says the OIG’s total monetary impact during the reporting period was $16.61 billion, including $3.51 billion in investigation receivables, $451 million in audit receivables, and $12.65 billion in potential cost savings. It says the return on investment for OIG is $11 for every $1 spent, based on a three-year rolling average of expected recoveries and receivables from OIG work.