Opioid Crisis Accountability Act of 2019

Opioid Crisis Accountability Act of 2019

This bill establishes a series of restrictions and requirements relating to opioid marketing and distribution practices.

Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors are subject to civil penalties and imprisonment for violations; corporations and executives are subject to civil penalties. Manufacturers shall also lose their period of market exclusivity.

Additionally, the Department of Health and Human Services must assess a fee against each corporation that, between January 1, 1993, and the date of enactment of this bill, manufactured or distributed opioids, if such opioids were covered under a federal health program at least once during this period. Manufacturers that fail to pay the fee shall lose associated drug approval until the fee is paid in full.

The bill authorizes collected civil penalties and fees to be used for activities that address opioid misuse and abuse, including family and educational programs.