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# Accelerated Approval Withdrawals Likely to Increase: Attorneys
- URL: https://www.fdaweb.com/accelerated-approval-withdrawals-likely-to-increase-attorneys/
- Published: 2023-05-02T12:00:00.000Z
- Updated: 2026-09-14T18:29:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154340

Some 10% of accelerated approval drugs are subsequently withdrawn and that number may continue to grow as FDA emphasizes the need to ensure a higher level of safety and efficacy for accelerated approval drugs by more closely scrutinizing the approval process. That’s the view of attorneys **Dominick DiSabatino** and **Audrey Crowell** (SheppardMullin).

Writing in their firm’s online *FDA Law Update*, the two use the 4/5 withdrawal of Covis’ Makena (hydroxyprogesterone caproate injection) to discuss the takeaways for manufacturers of drugs granted accelerated approval.

“Given the abbreviated scope of evidence required under FDA’s accelerated approval process, the risk of subsequent withdrawal based on lack of clinical effectiveness may be higher for drugs that are approved under the accelerated approval pathway than those approved through a traditional approval pathway,” the attorneys write.

They say a possible counter to an increase in the number of withdrawals of accelerated approval drugs is that FDA has placed an enhanced focus on strategies to avoid post-approval withdrawals. “As a preventive approach,” they write, “FDA has urged accelerated approval applicants for oncology drugs to have confirmatory trials ‘fully accrued and underway’ before submitting an accelerated approval application.”

As part of its recommendation, the agency noted that the limited scope of evidence required for accelerated approval may not be appropriate in all clinical settings, and that applicants for certain drugs, such as oncology drugs, would benefit from providing more confirmatory evidence upfront. FDA also has shown an increased willingness to discuss creative solutions for identifying paths forward when post-approval confirmatory studies fail to verify clinical effectiveness, as shown by the lengthy docket associated with the Makena withdrawal, they conclude.