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The Opioid REMS Template

This article was originally published in RPM Report

Executive Summary

Here is the final version of the Risk Evaluation & Mitigation Strategy FDA is imposing on two dozen sponsors of long-acting opioids. It was included in a letter to the sponsors sent April 19.

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Controlling Opioids: REMS Meets Congressional Resistance

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.

Market Research with a Twist

As in any other REMS, a key burden on sponsors of long-acting opioids will be tracking the success the program. Here are the metrics FDA asks for in its April 19 REMS.

The Bigger Picture

Here are the many steps recommended in the Obama Administration’s Prescription Drug Abuse Prevention Plan, the vehicle for launching the final opioid REMS. Each recommendation is tagged to one or more agencies for action.





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