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Comment & Response
May 4, 2020

Assessing the Opioid Analgesic Risk Evaluation and Mitigation Strategy Program—Reply

Author Affiliations
  • 1Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2Office of Public Health Practice and Training, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 3Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 4Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, Maryland
JAMA Intern Med. Published online May 4, 2020. doi:10.1001/jamainternmed.2020.1112

In Reply We studied the US Food and Drug Administration’s (FDA’s) oversight and management of an industry-funded prescriber education program aimed at improving prescriber practices and reducing adverse events from use of prescription opioids.1 Five years into the Risk Evaluation and Mitigation Strategy (REMS) program governing extended release/long-acting (ER/LA) opioids, the FDA was unable to evaluate the effect of the REMS on prescribing behavior or safety outcomes.

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