The Opioid REMS Template
This article was originally published in RPM Report
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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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.
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.
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.