On July 10, the House of Representatives 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.

“Today’s passage of H.R. 6 demonstrates the House’s commitment to working together in a bipartisan manner to improve health care in the U.S. The increased mandatory funding for the NIH drives home the importance of innovation and medical research in 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. We thank Chairman Fred Upton (R-MI), Congresswoman Diana DeGette (D-CO), and their colleagues who spearheaded and advanced this praiseworthy effort.”

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 first round of ACC’s comments focused on the provisions affecting clinical data registries. The College, drawing on its vast experience in clinical data registries, stressed the importance of needs-based registry development, well-developed organizational structure and support, and data accuracy and quality. The College also underscored the importance of collaborating with stakeholders, including medical specialty societies and clinical data registry operators, on additional requirements that are imposed on registries. The second set of comments stressed the need to ensure patient access to innovative therapies and appropriate care. The College provided recommendations on priority review for breakthrough devices, modernizing the regulation of social media, coverage with evidence development, telemedicine, interoperability, precision medicine and more.

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, Cooperative Behavior, Delivery of Health Care, Precision Medicine, Information Dissemination, National Institutes of Health (U.S.), Patient Care, Research, Software, Telemedicine, United States Food and Drug Administration

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