21st Century Cures Act: Laudable Goals but Public Health Programs Pay the Price

Posted on January 16, 2017 by jphmpdirect

by Tina Batra Hershey, JD, MPH, and Elizabeth Van Nostrand, JD

Crossroads: Law and Public Health addresses topics related to the intersection of law and public health. This series highlights the perspectives of two attorneys turned academicians and explores legal and policy issues that impact public health.

The 21^st Century Cures Act (the Cures Act), signed into law on December 13, 2016, by President Obama, is the most sweeping healthcare legislation since the Affordable Care Act was passed in 2010. The Cures Act, one of the most heavily lobbied pieces of legislation in recent history, received advocacy efforts from pharmaceutical and medical device manufacturers, mental health organizations, patient advocacy groups, and medical researchers. As a result of these efforts and bipartisan support in Congress, the Cures Act passed in a lame duck session by a Congress with few other significant legislative accomplishments.

There is much to laud about the Cures Act, which gives $1 billion to states to address opioid use and addiction. In addition, it increases funding for mental health research and treatment, and establishes a new, presidentially appointed position in the Department of Health and Human Services – the Assistant Secretary for Mental Health and Substance Use. It also provides $4.8 billion over the next 10 years to the National Institutes of Health (NIH) to pursue two of President Obama’s pet projects: the BRAIN initiative, to discover new methods to combat brain disorders like Alzheimer’s disease and autism; and the Precision Medicine Initiative, which considers individual differences when selecting clinical treatments. Vice President Biden’s Cancer Moonshot Initiative, to expedite advances in cancer prevention, diagnosis, and treatment, is also funded by the NIH funding.

The Cures Act seeks to speed up the approval process for pharmaceuticals and medical devices. Pharmaceutical manufacturers can submit real-world evidence and data summaries instead of randomized clinical trial data to support new uses for drugs already on the market. Smaller clinical trials for antibacterial and antifungal drugs used to treat multidrug-resistant infections are permitted, and there is now an expedited “breakthrough device” pathway for those devices that provide more effective treatment for, or diagnosis of, certain diseases and conditions.

Unfortunately, public health programs will shoulder the burden of paying for these new initiatives. The Cures Act cuts $3.5 billion over the next 10 years from the Prevention and Public Health Fund budget, which supports prevention programs for smoking, diabetes, heart disease, and other preventable illnesses and injuries. Although the goal of furthering medical interventions is praiseworthy, its promotion should not be done at the expense of equally important initiatives, such as promoting breastfeeding, addressing racial disparities, and helping individuals manage their chronic diseases. Decreased funding for these and other preventive programs could lead to poorer health outcomes and reduced life expectancy in the future.

Although increased NIH funding is welcome news, the funding is not guaranteed and is subject to the whims of Congress. And it is disappointing that the Cures Act does nothing to address the rising and often astronomical cost of pharmaceuticals. Finally, certain consumer groups fear that weakening FDA standards will ultimately lead to patient harm, as drugs and devices are rushed to market with less stringent testing and government oversight.

Just like the Affordable Care Act, the 21^st Century Cures Act makes some solid strides in healthcare. However, important public health initiatives should not be cut to make these strides. Time will tell if the Cures Act leads to better health outcomes for all Americans, not just those associated with industry.