This week, members of the House Energy and Commerce Committee from both sides of the aisle came together to advance draft legislation that, if enacted, would streamline the Food and Drug Administration’s (FDA’s) regulatory process, modernizing clinical trials and medical product regulation, and support the development of innovative cures. On April 29, the Committee released an updated discussion draft of the 21^st Century Cures initiative. On April 30, exactly one year after the initiative was announced, the Subcommittee on Health will review the draft and the FDA and National Institutes of Health (NIH) will provide testimony during a legislative hearing on Capitol Hill.

“[The] 21^st Century Cures hearing continues to drive home the importance of innovation in health care as we all work together toward more cost effective care and improved patient outcomes,” said ACC President Kim Allan Williams, Sr., MD, FACC, in a statement. “Our health care system cannot afford to remain stagnant; the increased funding for the NIH in the 21^st Century Cures draft is an important acknowledgment of the need for robust research to generate new and improved ways to treat patients. The American College of Cardiology appreciates the House Energy & Commerce Committee’s collaborative approach and looks forward to ongoing dialogue with the Committee to continue the essential work of providing patients with better care.”  

The Committee outlined key provisions included in the draft as follows:

• Incorporate the patient perspective in the discovery, development, and delivery process
• Increase funding for the NIH, both through reauthorization and $10 billion over five years in mandatory funding, 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 increased collaboration and data sharing among patients, researchers, providers and innovators
• Help 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 Committee noted that they’ve “done things differently with 21st Century Cures.” The draft 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 continues to refine 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.

“While we have made significant progress over the last year, there is still work left to do, and our staffs, as they have done for months, will continue working round the clock to ensure that the finalized legislation can gain broad support,” Committee leaders noted.

In the coming months, the ACC will continue to help shape the future of health care by working with Congress on 21^st Century Cures.

Keywords: Delivery of Health Care, Precision Medicine, Information Dissemination, Medicine, National Institutes of Health (U.S.), Registries, Research Personnel, Social Media, Societies, Medical, Software, Telemedicine, Therapies, Investigational, United States Food and Drug Administration

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