21st Century Cures Fact Sheet

Lauded as the most comprehensive piece of federal healthcare legislation since the passage of the Patient Protection and Affordable Care Act in 2010, the Act incorporates a wide range of policy objectives including modifications to the Food and Drug Administration (FDA) drug approval process, research and funding opportunities for the National Institutes of Health (NIH), and measures to address the country’s escalating opioid crisis. While the Act passed with bipartisan support, some have underscored the Act’s shortcomings in addressing high drug costs, patient safety concerns, and unease about annual NIH funding reauthorization. This fact sheet summarizes major components of the Act while also addressing areas of concern as implementation of its major provisions moves forward.

The 21st Century Cures Act was the result of almost two years of deliberation in Congress and was signed into law in December 2016; The Act included significant changes to the FDA drug approval process, including provisions to fast-track approval of drugs; Research funding and support mechanisms were also incorporated, including funding for the Precision Medicine Initiative and the Cancer “Moonshot” Program; Provisions of the legislation also support mental health and substance abuse initiatives, including State Targeted Response to the Opioid Crisis Grants.