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Comment & Response
May 4, 2020

Assessing the Opioid Analgesic Risk Evaluation and Mitigation Strategy Program

Author Affiliations
  • 1Division of Risk Management, US Food and Drug Administration, Silver Spring, Maryland
  • 2Office of Medication Error Prevention and Risk Management, US Food and Drug Administration, Silver Spring, Maryland
  • 3Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland
  • 4Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
  • 5Public Health Initiatives, US Food and Drug Administration, Silver Spring
JAMA Intern Med. Published online May 4, 2020. doi:10.1001/jamainternmed.2020.1260

To the Editor We note the review by Heyward et al1 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 REMS, a voluntary continuing education (CE) program.2 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.

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