Heart of Health Policy | Members of the House Energy and Commerce Committee from both sides of the aisle came together in April to advance draft legislation that, if enacted, would streamline the U.S. Food and Drug Administration’s (FDA’s) regulatory process, modernizing clinical trials and medical product regulation, and support the development of innovative cures. Shortly after the Committee released an updated discussion draft of the 21st Century Cures initiative, the Subcommittee on Health held a legislative hearing on Capitol Hill to review the draft and hear testimony from the FDA and National Institutes of Health (NIH).

“[The] 21st 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. “Our health care system cannot afford to remain stagnant; the increased funding for the NIH in the 21st Century Cures draft is an important acknowledgment of the need for robust research to generate new and improved ways to treat patients. The ACC appreciates the House Energy and 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 fiscal year 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 proposal 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 also submitted two rounds of comments on the first discussion draft to help guide the Committee as it continues to refine the proposal.

“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.

Moving forward, the ACC will continue to help shape the future of cardiology by working with Congress to advance 21st Century Cures.

Keywords: Cardiology Magazine, ACC Publications, Cooperative Behavior, Delivery of Health Care, Health Services Needs and Demand, Precision Medicine, Information Dissemination, National Institutes of Health (U.S.), Software, Telemedicine, United States Food and Drug Administration

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