Class-Wide REMS: "A Self-Propagating Purgatory"
This article was originally published in RPM Report
It hasn't been easy for two dozen companies to work together in trying to craft a viable class-wide risk management program for long-acting opioids. If they are successful, expect FDA to push for more class-wide REMS.
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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.
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.
Pfizer’s $3.3 billion acquisition of King eliminates the primary opportunity for investors to play in the abuse-resistant formulation space and renewed questions about the logic of perpetual expansion atop Big Pharma. But the realities of the abuse resistant marketplace suggest it makes a good case for scale and diversity. Is this a sign of things to come in other drug classes?