Heart of Health Policy | The House of Representatives on July 10 passed legislation that would provide significant new funding for the National Institutes of Health (NIH) and streamline the U.S. Food and Drug Administration's (FDA's) regulatory process – modernizing clinical trials and medical product regulation – to support the development of innovative cures. H.R. 6, the 21st Century Cures Act, earned broad bipartisan support and passed the House by a 344 – 77 vote.

"The increased mandatory funding for the NIH drives home the importance of innovation and medical research, and the health care community's efforts to improve patient outcomes through new treatments," said ACC President Kim Allan Williams Sr., MD, FACC. The U.S. has long been a leader in medical research that has advanced patient care throughout the world. Our health care system – and more importantly our patients – can't afford for us to become stagnant. This legislation helps address that need."

The key provisions of H.R. 6 are as follows:

• Incorporate the patient perspective in the discovery, development and delivery process
• Increase funding for the NIH and FDA, both through reauthorization and over $9 billion in mandatory funding over five years, starting in FY 2016
• Foster development of treatments for patients facing serious or life-threatening diseases
• Repurpose drugs for serious or life-threatening diseases and conditions
• Modernize clinical trials
• Break down barriers to increase collaboration and data sharing among patients, researchers, providers and innovators
• Support the development of personalized and precision medicines so the right patient can receive the right treatment at the right time
• Provide for continued work in the telehealth space Advance a truly interoperable health care system
• Provide clarity for developers of software products used in health management and medical care

The House Energy and Commerce Committee, which drafted the original bill, noted that it has "done things differently with 21st Century Cures." The legislation is the result of months of bipartisan efforts to solicit feedback from "every corner of the health care innovation infrastructure." The ACC had a chance to provide insight into health care innovation when ACC Immediate Past President Patrick T. O'Gara, MD, MACC, shared cardiology's perspective during a roundtable discussion on personalized medicine last summer. The College has also submitted two rounds of comments on the first discussion draft to help guide the Committee as it refined the proposal.

The legislation will now move to the Senate, where the outlook is still unclear. The ACC will continue to help shape the future of health care by working with Congress on important concepts included in 21st Century Cures.

Keywords: Biomedical Research, Precision Medicine, Telemedicine, United States Food and Drug Administration, Research

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