President Obama Signs the 21st Century Cures Act

President Obama signed what is among the largest healthcare packages since the Affordable Care Act into law, capping more than a year of bipartisan negotiations on the 21st Century Cures Act.  The sweeping package of biomedical innovation bills also included legislation to improve U.S. mental health care, funding for several of the administration’s key health initiatives, and money to help states combat the opioid epidemic. Importantly for PF, the “Cures” bill will direct $4.8 billion in funding to the NIH over 10 years.

The nearly 1,000-page legislative package alters the way some products gain Food and Drug Administration (FDA) approval, including placing a greater emphasis on patients' perspectives in the review of drugs. It also establishes an abbreviated new pathway for innovative medical devices, similar to a program that currently exists for prescription drugs. Additionally, the measure changes the leadership structure at the Substance Abuse and Mental Health Services Administration (SAMHSA) and imposes several new transparency requirements on the National Institutes of Health (NIH). Language included in the final package creates and reauthorizes grants for state and community mental health care and encourages more representation from certain populations in clinical trials.

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The 21st Century Cures Act will direct $4.8 billion in funding to the NIH over 10 years, specifically for programs including President Obama’s Cancer Moonshot Initiative. It also will direct $500 million over nine years to the FDA and $1 billion to states over two years to help fight prescription drug abuse, although appropriators will still have to sign off on the use of that funding in future years. A previous version of the legislation that passed the House last year (H.R. 6) would have provided a mandatory stream of money for the NIH and the FDA.