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# Califf Vows Tough Accelerated Approval Enforcement
- URL: https://www.fdaweb.com/califf-vows-tough-accelerated-approval-enforcement/
- Published: 2022-02-04T12:00:00.000Z
- Updated: 2026-09-14T17:31:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151088

FDA commissioner nominee **Robert Califf** is promising, if confirmed by the Senate, to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments. In a bid to gain the backing of Senator **Ron Wyden** (D-OR) for his nomination vote, Califf vowed within 30 days of taking office to “take strong action to hold companies accountable for producing the required scientific evidence after obtaining accelerated approval.” Califf’s promise was disclosed in a [2/4 letter ](https://www.finance.senate.gov/imo/media/doc/020422%20Wyden%20Letter%20to%20Califf%20on%20Accelerated%20Approval.pdf?ref=fdaweb.com)from Wyden asking for more details on enforcing accelerated approval confirmatory evidence obligations.

Wyden’s letter took issue with companies taking advantage of the accelerated approval pathway without seeking adequate confirmatory evidence, calling into question FDA’s lack of enforcement “to hold drug companies accountable for fulfilling their obligations.” It asked Califf to explain the standard he will use to determine whether a company has failed to comply with confirmatory evidence requirements. The letter also asked how the agency would hold laggard companies accountable and which existing authorities are best to use. And if his actions do not lead to success, Califf was asked if he would request additional authorities from Congress.