21st Century Cures for the Opioid Crisis: Promise, Impact, and Missed Opportunities

Abstract

Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive. For some stakeholders, including patient groups and representatives of regulated industries, the Act represented a major leap forward in pharmaceutical innovation, human subjects protections, and numerous other provisions. For other observers, this legislation was characterized as a major rollback in important regulations, which would leave patients worse off and the payers holding the bag. The one element of the Act that was relatively uncontroversial covered a number of provisions related to addressing the opioid crisis.This was by design. Provisions related to this issue were not part of the original legislation and were added to win over additional members of Congress who needed to be brought along to support the legislation. Many of the statute's provisions were intertwined with the Comprehensive Addiction Recovery Act (“CARA”) passed previously, but that legislation was stripped of much of its funding for opioid crisis response.