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FEDERAL | 21st Century Cures is Signed into Law

ASPS has championed the 21st Century Cures Act since its introduction in 2015, and before Congress headed home for the holidays, lawmakers passed the bill with overwhelming bipartisan support. The bill invests significant funding in medical innovation, curing Alzheimer's disease and funds Vice President Biden's Cancer Moonshot initiative. The House of Representatives passed the legislation on November 30; the Senate passed the bill on December 7; and President Obama signed it into law on December 13.

ASPS's comments generally supported the bill and asked for some minor modifications. Specifically, ASPS requested Congress to clarify that data registries that track healthcare quality should be able to easily use and disclose protected health information. ASPS expressly supported provisions expanding opportunities for young scientific researchers and supported centralizing the Institutional Review Board Process. Additionally, ASPS wrote in favor of the creation of a new "regenerative advanced therapy" U.S. Food and Drug Administration designation. This new designation will expedite the review of potential breakthrough regenerative therapy products. ASPS also advocated for the provisions in the Act that seek to improve interoperability between electronic health record systems and makes clear that data blocking is impermissible.

Ultimately, the bill passed with broad-based support in from both parties. However, those not supporting the package, like Senators Elizabeth Warren (D-MA) and Bernie Sanders (D-VT), cited concerns that the bill was a windfall for pharmaceutical manufacturers and did not address drug pricing issues. Other members expressed concerns over the high cost of the legislation. The final package contains a total of $6.3 billion in spending. This includes $4.8 billion in funding over 10 years for the National Institutes of Health (NIH).

Read ASPS's Comments Supporting the 21st Century Cures Act