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# Researchers Urge Better FDA Monitoring of Post-approval Studies
- URL: https://www.fdaweb.com/researchers-urge-better-fda-monitoring-of-post-approval-studies/
- Published: 2017-09-22T12:00:00.000Z
- Updated: 2026-09-14T22:52:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139689

Researchers from the Dartmouth Institute for Health Policy and Clinical Practice believe FDA should be doing more to ensure pharmaceutical sponsors meet post-approval study deadlines. With many approval candidates lagging on safety and effectiveness when drugs are first approved, the agency requires post-approval (Phase 4) studies to further examine these. To see how FDA is policing post-approval study requirements, the researchers looked at 614 postapproval requirements imposed in 2009 and 2010\. “After five to six years, 20% of postapproval studies had not been started, 25% were delayed or ongoing, and 54% had been completed,” according to their [perspective](http://www.nejm.org/doi/full/10.1056/NEJMp1705800?ref=fdaweb.com) in the 9/20 *New England Journal of Medicine*.

To better make sure sponsors meet post-approval deadlines, FDA should use its statutory authority to impose fines or other penalties on sponsors that fail to comply. “To our knowledge, it has never imposed such fines,” the researchers write. Additionally, they believe the agency “should consider setting shorter completion deadlines. One approach would be to reduce the time between drug approval and initiation of postapproval studies by identifying postapproval requirements as early in the review process as possible. Reasonable deadlines for clinical study conduct can be estimated from the *ClinicalTrials.gov* database, which lists start and completion dates for most clinical trials of drugs. Many pharmacokinetic and pharmacodynamic studies, for example, can be done in months rather than years.”

FDA defended its complicated tracking of post-approval studies in an accompanying [letter to the editor](http://www.nejm.org/doi/full/10.1056/NEJMc1709185?query=TOC&ref=fdaweb.com) and noted that the studies examined were just a snapshot in time. “Many factors influence the timely conduct of a study; for example, low use of a product on the market or changes in the standard of care can reduce the number of patient records available for pharmacoepidemiologic studies,” agency officials wrote. “The FDA assesses the justification for any delays and, if the justification is appropriate, monitors adherence to a revised timetable. The reported status of a postmarketing requirement or commitment is based on the original timetable; therefore, even when there is a well-justified change in the timetable, the status is reported as ‘delayed’ until the next milestone is met.” They said that studies that the researchers categorized as “not started” may actually have been initiated but not completed.

Additionally, FDA said that “advances in science, changes in standards of care, and new clinical information can affect study feasibility, design requirements, and even the need for or the appropriateness of a study. A manufacturer may therefore terminate a study, or the FDA may release the postmarketing requirement or commitment or replace it with a new one that is aligned with current science and practice. The FDA tracks these circumstances carefully and works with manufacturers to ensure that the postmarketing requirement or commitment study provides the information needed for public health.”

FDA further wrote that it is dedicated to improving post-marketing study oversight and the transparency of its reporting. “We think that it is reassuring that as of fiscal year 2015, a total of 88% of postmarketing requirements overall and 89% of \[regulatory\] postmarketing requirements were progressing according to their original schedules.”