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Following a multi-year, bipartisan, and bicameral legislative effort to accelerate the pace of the discovery, development, and delivery of new treatments and cures, the 21st Century Cures Act (Cures Act) was signed into law by President Obama on December 13, 2016. The Cures Act includes President Obama’s proposals for the Precision Medicine and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiatives, as well as provisions intended to enhance and accelerate the Food and Drug Administration’s processes for reviewing and approving new drugs, biologics, and medical devices. The Cures Act also includes US$1 billion in new funding to address the opioid crisis over two years, streamline administrative processes for the National Institutes of Health’s funding of medical research, fund new NIH research on human genetics and neuroscience, and facilitate secure, interoperable exchange of electronic health record data while protecting patient privacy. While the Cures Act institutes important changes in FDAMA 114, significantly liberalizing the communication of healthcare economic information to payers, it does not address drug manufacturers’ broader concerns about the FDA’s restrictive policies regarding the communication of scientific and medical developments regarding unapproved uses. In addition to the medical innovation provisions, the Cures Act includes provisions of the House-passed H.R. 2646, “Helping Families in Mental Health Crisis Act,” and S. 2002, “Mental Health and Safe Communities Act,” as well as several Medicare reforms.

We've prepared an Advisory describing the provisions of the new law.