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FDA to require class-wide REMS for opioid drugs

This article was originally published in The Gold Sheet

Executive Summary

Manufacturers of potent opioid drug products will soon be required to have a Risk Evaluation & Mitigation Strategy (REMS) in place to mitigate the potential risk of drug abuse. FDA announced on Feb. 11 that letters were sent to 16 manufacturers of 24 marketed products notifying them of the new requirement. The focus of the class-wide program will be on products that FDA says are most prone to abuse: extended-release tablets and transdermal patches, including fentanyl, methadone and oxycodone. There have been manufacturing problems related to some of these products, especially the fentanyl patches which have been found to have defective delivery systems with patches potentially leaking fentanyl gel (see "The Gold Sheet," Jan. 2009, p. 18)

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