Ask the Expert On Demand Webinar: Do We Need REMS?-ATEW On Demand: Do We Need REMS?

Video Transcription

Video Summary

The webinar explored Risk Evaluation and Mitigation Strategies (REMS) and whether they are needed to ensure medication safety. Dr. Winterstein reviewed the history of drug regulation, from early disasters like sulfonamides and thalidomide to modern FDA safety tools, explaining that REMS were created when labeling alone is not enough to prevent serious harm. She described REMS components such as medication guides, prescriber/pharmacy certification, pregnancy testing, monitoring, and restricted dispensing.<br /><br />Using epilepsy-related examples, she showed that REMS can work when they target the right failure point. A phentermine/topiramate REMS reduced pregnancy exposure compared with generic topiramate, while a mycophenolate REMS lowered treatment initiation during pregnancy but did not reduce conception during use. She also discussed vigabatrin, fenfluramine, and isotretinoin as examples of more restrictive safety systems.<br /><br />A major takeaway was that some drugs with serious teratogenic risk, especially valproate, may need stronger safeguards because current warnings appear insufficient. Dr. Winterstein argued that REMS should be tailored to the actual risk and real-world use patterns, balancing safety with access. The session concluded with discussion of how long REMS should remain in place and how FDA decisions may evolve as evidence accumulates.

Keywords

REMS

medication safety

FDA drug regulation

teratogenic risk

valproate

pregnancy exposure

risk mitigation

prescriber certification

restricted dispensing