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The Opioid REMS: Health Care Reform, One Class at a Time

This article was originally published in RPM Report

Executive Summary

FDA is planning a spring meeting to discuss next steps in a class-wide Risk Evaluation & Mitigation Strategy for opioids. The outcome will redefine the rules of commercial success in the pain class-and provide a critical case study for how FDA's new regulatory tools may reshape other sectors over time. The good news: there appear to be new opportunities amid the change. The bad: industry is definitely not driving the process.

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Regulatory Alchemy: The Transformative Power of the Opioid REMS

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.

The New Drug Safety Committee Members

Here are profiles of the newly appointed members of FDA's Drug Safety & Risk Management Advisory Committee.

Transmucosal Fentanyl Products Become First Plug-and-Play REMS

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.

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