Regulatory Alchemy: The Transformative Power of the Opioid REMS
This article was originally published in RPM Report
Executive SummaryThe 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.
You may also be interested in...
FDA approved Zogenix’ single-entity hydrocodone product following a negative advisory committee meeting, and is facing ongoing opposition as the drug’s launch begins. The agency argues the risk is consistent with other extended-release opioids – and abuse-deterrent technology is too new to require.
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.
As the fifth year of the REMS era begins, FDA is imposing mandatory programs less frequently than it did even in the first year after the law creating formal risk management plans took effect. But there are some new trends to watch, including the evolution of REMS classes and the emergence of products with REMS-in-waiting.