The Latest on Opioid REMS: FDA Wants More Robust Strategy


As reported in “Take Action on Opioids” in the Winter 2010 issue of the ICA Update, for the past several years a panel within the US Food and Drug Administration (FDA) has overseen the Risk Evaluation and Mitigation Strategies (REMS) formulation process for long-acting/extended release opioid drugs. On July 23rd, this panel voted 25 to 10 against the proposed strategy presented at a recent two-day public meeting.

FDA panel members unanimously agreed that a REMS proposal is needed; however, they voiced concerns about several components of this draft of the proposal. The Panel indicated the need for more stringent, robust requirements for opioid prescribing, specifically:
  • Mandatory provider education requirements
  • The inclusion of pharmacists in the group of providers to be educated
  • Coverage of immediate acting opioids in any REMS requirements.

The rejected proposal had three major components: medication guides for patients, educational programming for prescribers, and education materials for patients developed by pharmaceutical companies. Recognizing the enormous burden on the healthcare system and potential to limit patient access to opioids, the proposal did not include several, more controversial elements that had originally been suggested—such as enrollment of prescribers into a REMS registry and real-time electronic verification of prescriber training at pharmacies.

The FDA continues to seek input from patients, healthcare providers, pharmacists, and industry stakeholders about this proposed regulation. The comment period runs through October 19, 2010. Learn how to submit a comment.

Posted August 05, 2010