Controlling Opioids: REMS Meets Congressional Resistance
This article was originally published in RPM Report
Executive Summary
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.
You may also be interested in...
A Fitting Farewell: Hamburg Earns Praise From Rep. Rogers In Final Approps Hearing
FDA Commissioner Margaret Hamburg and House Appropriations Chair Hal Rogers (R-KY) have had ups and downs over the years, but Rogers praised her and her legacy on prescription abuse.
Seeking Guidance On Abuse-Deterrence: Sponsors Fall Short, Congress Urges Action
Congressional appropriators are urging FDA to move quickly to finalize guidance on abuse deterrence claims for opioids—and to take the next step and prohibit marketing of products that don’t deter abuse. FDA says the science isn’t there yet, and two sponsors join the list of those who have failed to clear the hurdle.
DEA Delays in Scheduling Are Offsetting FDA’s Improved Decision Making
FDA is showing a renewed commitment to meeting review deadlines for new molecular entities, but that is not translating into earlier commercial availability for all NMEs. Some products also need a controlled substance scheduling decision from the Drug Enforcement Administration; those actions have become a new regulatory purgatory that can be painful and frustrating.