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# Groups Want Stronger Post-Market Trial Enforcement
- URL: https://www.fdaweb.com/groups-want-stronger-post-market-trial-enforcement/
- Published: 2022-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:45:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151887

More than 35 health experts and advocacy groups including U.S. PIRG (Public Interest Research Group) are calling on the Senate HELP Committee to include stronger enforcement of post-market clinical trials for accelerated approval drugs in its coming markup of draft FDA user fee legislation. U.S. PIRG [says](https://uspirg.org/news/usp/release-consumer-groups-health-experts-call-changes-accelerated-drug-approval-fda-reform?ref=fdaweb.com) its [letter](https://uspirg.org/resources/usp/coalition-letter-senate-help-committee-fda-user-fee-discussion-draft?ref=fdaweb.com) indicates that drug companies have not consistently started or completed their required post-marketing trials, meaning that “too many products have lingered on the market and potentially endangered patients who continue to take these medications.”

The groups recommend these changes: 

- manufacturers complete their post-market studies to confirm a drug’s predicted clinical benefit;
- FDA automatically remove from the market drugs approved through the accelerated approval pathway that have not demonstrated they offer clinical benefit after five years; and
- FDA require that clinical trials be already underway when an approved drug comes to market to lessen the time between approval and the end of the full clinical trial.