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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.Table of ContentsFront MatterSummary1 IntroductionPART I: PAIN MANAGEMENT AND RESEARCH2 Pain Management and the Intersection of Pain and Opioid UseDisorder3 Progress and Future Directions in Research on Pain and Opioid UseDisorderPART II: ADDRESSING THE OPIOID EPIDEMIC4 Trends in Opioid Use, Harms, and Treatment5 Evidence on Strategies for Addressing the Opioid Epidemic6 Opioid Approval and Monitoring by the U.S. Food and DrugAdministrationAPPENDIXESAppendix A: Data Sources and MethodsAppendix B: Biographical Sketches of Committee Members andConsultantsAppendix C: Existing Data Sources on Opioid Use, Misuse, Overdose,and Other Harms