Assessing the Opioid Analgesic Risk Evaluation and Mitigation Strategy Program

To the Editor We note the review by Heyward et al critiquing the US Food and Drug Administration ’s (FDA’s) oversight of the extended-release/long-acting (ER/LA) opioid analgesic Risk Evaluation and Mitigation Strategy (REMS). The authors’ conclusions reiterate those that the FDA presented at a public advisory committee meeting on May 3 and 4, 2016, regarding the assessment of the ER/LA R EMS, a voluntary continuing education (CE) program. At this meeting, there was discussion of how this REMS was 1 among many educational activities and other interventions being implemented at local, state, and federal levels to address the opioid crisis.
Source: JAMA Internal Medicine - Category: Internal Medicine Source Type: research