BOX 6-6Recommendations for Other Regulatory Decisions

Recommendation 6-6. Conduct a full review of currently marketed/approved opioids. To consistently carry out its public health mission with respect to opioid approval and monitoring, the U.S. Food and Drug Administration should develop a process for reviewing, and complete a review of, the safety and effectiveness of all approved opioids, utilizing the systems approach described in Recommendation 6-1.

Recommendation 6-7. Apply public health considerations to opioid scheduling decisions. To ensure appropriate management of approved opioids, the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration should apply the same public health considerations outlined in Recommendation 6-1 for approval decisions to scheduling and rescheduling decisions, and study empirically the outcomes of scheduling determinations at the patient and population health levels.

From: 6, Opioid Approval and Monitoring by the U.S. Food and Drug Administration

Cover of Pain Management and the Opioid Epidemic
Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors.
Washington (DC): National Academies Press (US); 2017 Jul 13.
Copyright 2017 by the National Academy of Sciences. All rights reserved.

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