[20180306]LSB10049_应对类阿片流行病：法律发展和FDA的作用.pdf

CRS Legal Sidebar Prepared for Members and Committees of Congress Legal SidebarLegal Sidebari i Responding to the Opioid Epidemic: Legal Developments and FDAs Role Updated March 6, 2018 According to the Centers for Disease Control and Prevention, “115 Americans die every day from an opioid overdose,” and deaths from prescription opioids have more than quadrupled since 1999. The epidemics origins are complex, with fingers pointed at pharmaceutical manufacturers and distributors, addicts and dealers, health care professionals, and insurance companies. Like the causes of the opioid epidemic, any solutions to the problem will likely involve many actors, including the federal government. The Food and Drug Administration (FDA)the executive agency charged with protecting the public health by ensuring the nations drug supply is safe and effectivehas developed an “opioids action plan,” discussed in more detail below. Nonetheless, questions remain as to what actions the agency should take and whether the agencys existing authorities are adequate for addressing the crisis. This Sidebar provides an overview of FDAs existing authorities, the historical context for the opioid epidemic, and the