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Controlling Opioids: REMS Meets Congressional Resistance

This article was originally published in RPM Report

Executive Summary

The Food & Drug Administration’s work on curbing abuse of long-acting opioids hasn’t lacked for outreach. The three-year long effort to develop a formal Risk Evaluation & Mitigation Strategy to help ensure appropriate use of products like Purdue Pharma’s OxyContin has involved input from two dozen different manufacturers, formal presentations by more than 75 outside stakeholder groups, and literally hundreds of public comments.

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