Opioid REMS: Committee Rejects FDA Proposal, But Sponsors Should Embrace It
This article was originally published in RPM Report
The combined Anesthetic & Life Support Drugs and Drug Safety & Risk Management advisory committees voted strongly (25-10) against FDA’s proposed classwide educational REMS for long-acting opioids; but the vote does not stop the process. In fact, FDA may have achieved much of what it set out to do by just by proposing a class REMS in the area.
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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.
The three-year long process towards a class-wide Risk Evaluation & Mitigation Strategy has been anything but straightforward. Still, the final twist may be the most surprising: FDA is now espousing the most industry-friendly approach on the table. The details of the opioid REMS will take months to work out and years to judge, but understanding the choices made in crafting this policy are a critical starting point.
When it comes to attempts to control misuse of fast-acting opioids, FDA’s intentions have backfired in the past. Success could point to a likely process for future class-wide REMS.