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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Heyward J, Sharfstein J, Alexander GC. Assessing the Opioid Analgesic Risk Evaluation and Mitigation Strategy Program—Reply. JAMA Intern Med. Published online May 04, 2020. doi:10.1001/jamainternmed.2020.1112
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