US House of Representatives Approves 21st Century Cures Act

July 16, 2015—The Energy and Commerce Committee of the US House of Representatives announced last week that H.R. 6, the 21st Century Cures Act, was approved by a bipartisan vote of 344 to 77. The legislation was drafted by a bipartisan team led by Committee Chairman Fred Upton (R-MI) and House Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO). In May, the Energy and Commerce Committee voted 51-0 for approval. The bill now moves to the US Senate for consideration.

According to the committee, the nonpartisan legislation will invest in science and medical innovation, incorporate the patient’s perspective, and modernize clinical trials to deliver better, faster cures to more patients. The committee’s web page provides background information and details about the legislation here.

A committee statement issued before the full House vote summarized key features of the legislation including the establishment of a temporary Innovation Fund that is fully offset and retains the critical role of the Appropriations Committee to determine the specific biomedical spending priorities through the regular appropriations process each year of its 5-year life.

The legislation has been supported by a number of advocacy groups and medical societies, including the American College of Cardiology, the Association of Clinical Research Organizations, and the Advanced Medical Technology Association. The Advanced Medical Technology Association's President and CEO Stephen J. Ubl issued a statement that is available in full here. The Association of Clinical Research Organizations' Executive Director Doug Peddicord's statement is available here.

In a statement available here, the American College of Cardiology outlined the key provisions of H.R. 6:

• Incorporate the patient perspective in the discovery, development, and delivery process
• Increase funding for the National Institutes of Health and the US Food and Drug Administration, both through reauthorization and over $9 billion in mandatory funding over 5 years, 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 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