Bipartisan Leaders Release #Cures2015 Discussion Draft as Legislative Process Continues
WASHINGTON, DC – After nearly a year of listening to patients, innovators, researchers, providers, consumers, and regulators, bipartisan Energy and Commerce Committee leaders have released a discussion draft marking continued progress in the 21st Century Cures initiative. On Thursday, exactly one year to the day since full Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched the initiative, the Subcommittee on Health will hold a legislative hearing to review the draft. The committee has held eight hearings, issued a number of white papers, and committee members have hosted more than two-dozen roundtables across the country to generate ideas for this initiative. The discussion draft is the product of months of bipartisan negotiations and bipartisan staff continues working toward finalized legislation.
Chairman Upton, Oversight and Investigations Subcommittee Ranking Member DeGette, full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX) together released the draft. The draft legislative text is available online here.
The five bipartisan leaders said, “We’ve done things differently with 21st Century Cures, taking our time to listen and solicit feedback from every corner of the health care innovation infrastructure. It is because of this transparent, collaborative process that we are now ready and excited to take the next step in boosting research and delivering hope to patients and families all across the country. The ideas outlined in this draft represent a year of listening and working together to develop a product that we believe will truly help patients and bring our health care innovation infrastructure into the 21st century.”
The bipartisan leaders continued, “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. We look forward to Thursday’s testimony from the NIH and FDA and appreciate the input and involvement of all those who have been a part of this truly collaborative effort.”
The discussion draft includes provisions to:
• Incorporate the patient perspective in the discovery, development, and delivery process.
• Increase funding for the National Institutes of Health, 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.
A complete section-by-section summary of the discussion draft is available online here.
A one-page summary is available online here.
Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the National Institutes of Health, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA will testify at Thursday’s hearing.
Learn more about 21st Century Cures online here.