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# Expedited Drugs Have More Safety Labeling Issues: Study
- URL: https://www.fdaweb.com/expedited-drugs-have-more-safety-labeling-issues-study/
- Published: 2017-09-08T12:00:00.000Z
- Updated: 2026-09-14T22:47:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139584

A new [study](http://www.bmj.com/content/358/bmj.j3837?ref=fdaweb.com) in *The BMJ* found an association between expedited drug development and review pathways and the likelihood of subsequent safety-related labeling changes. “Further research is required to understand the underlying process factors contributing to the differential rates in safety changes that were observed in this analysis,” the study authors wrote. “Policymakers will likely need to ensure that these pathways are not overused, that there is sufficiently close post-approval monitoring of drugs approved through these pathways, and that patients and physicians are fully informed of the risks that accompany the widespread use of expedited development and regulatory review pathways in the approval of new drugs.”

The study reviewed 382 new drugs — 135 (35%) benefited from an expedited development or review pathway. The authors found that expedited pathway drugs “were characterized by a rate of 0.94 safety related label changes for each drug per year, compared with 0.68 safety related label changes per year for non-expedited pathway drugs (rate ratio 1.38, 95% confidence interval 1.25 to 1.52). Compared with non-expedited pathway drugs, expedited pathway drugs had a 48% higher rate of changes to boxed warnings and contraindications, the two most clinically important categories of safety warnings (1.48, 95% confidence interval 1.07 to 2.06).”