FDA approves REMS modification, advancing new drug disposal option
[10/31/2024] Today, the U.S. Food and Drug Administration is announcing approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS).
With this approval, companies participating in the OA REMS Program have been notified that they will be required to begin providing pre-paid drug mail-back envelopes upon request to outpatient pharmacies and other dispensers of opioid analgesics by March 31, 2025.
Once fully implemented, FDA intends for patients and caregivers to be provided a free, pre-paid drug mail-back envelope by outpatient pharmacies or other dispensers of opioid analgesics that order MBEs from the OA REMS. Other changes to the OA REMS enacted by this approval include:
- updates to the related Patient Guide to include information about the risk of unused OAs and the importance of safe disposal;
- a new Patient Education Sheet explaining the risk of unused OAs and the importance of safe disposal to be included with each pre-paid drug MBE.
“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health at the Center for Drug Evaluation and Research. “That is why we approved this modification and are continuing to explore other innovative in-home drug disposal methods to increase safe disposal of unused OAs.”
Today’s approval followed several prior agency actions related to FDA requiring an OA REMS modification, namely, an April 2022 Federal Register notice seeking public comment on the potential OA REMS modification; an April 2023 letter FDA sent to manufacturers of opioid analgesics used in outpatient settings, informing them that they were required to submit a proposed modification to the OA REMS within 180 days of the date of the notice; FDA’s participation in the National Academies of Sciences, Engineering, and Medicine’s June 2023 public workshop evaluating in-home drug disposal options; publishing an updated version of FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (FDA Blueprint) and awarding a grant through the University of Maryland to study commercial in-home disposal products.
Approval of this OA REMS modification is a testament to FDA’s continuing efforts and progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. As we move forward in fully executing that vision, we remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.