Opioid Epidemic and the Food and Drug Administration: Legal Authorities and Recent Agency Action [June 5, 2018] [open pdf - 835KB]
"According to the Centers for Disease Control and Prevention (CDC), '115 Americans die every day from an opioid overdose,' and deaths from prescription opioids have more than quadrupled since 1999. The epidemic's 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 branch agency tasked with protecting the public health by ensuring the nation's drug supply is safe and effective--has a central role in addressing widespread drug abuse, including the opioid epidemic. Given the severity of the opioid epidemic and its prominence as a matter of national concern, efforts to combat the issue will likely continue to be of significant interest to Congress. This report focuses on FDA as a key player in these efforts. The report provides a brief overview of FDA's role in approving new prescription drugs, including opioids, and also addresses selected examples of the agency's existing legal authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act) and recent action taken with respect to the opioid crisis. The report concludes with a discussion of selected opioid-related legislative proposals in the 115th Congress that would amend the FD&C Act."
CRS Report for Congress, R45218