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 Contents Front Matter Summary 1 Introduction PART I: PAIN MANAGEMENT AND RESEARCH 2 Pain Management and the Intersection of Pain and Opioid Use Disorder 3 Progress and Future Directions in Research on Pain and Opioid Use Disorder PART II: ADDRESSING THE OPIOID EPIDEMIC 4 Trends in Opioid Use, Harms, and Treatment 5 Evidence on Strategies for Addressing the Opioid Epidemic 6 Opioid Approval and Monitoring by the U.S. Food and Drug Administration APPENDIXES Appendix A: Data Sources and Methods Appendix B: Biographical Sketches of Committee Members and Consultants Appendix C: Existing Data Sources on Opioid Use, Misuse, Overdose, and Other Harms