Upton, DeGette unveil next steps for 21st Century Cures 2.0
While 21st Century Cures focused on the discovery of new cures, second iteration of landmark legislation will explore ways to modernize the delivery of treatments to patients
Washington, April 27, 2020 | Josh Paciorek (202-225-3761)
WASHINGTON, D.C. – U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) today released the concept paper for their bipartisan “Cures 2.0.” The 12-page concept paper unveils high-level areas of focus for Cures 2.0, which will look to modernize the delivery of health care in the wake of the coronavirus pandemic. Click here for the Cures 2.0 concept paper.
“Our world today faces the worst public health crisis in more than a century, and Cures 2.0 offers hope for today’s pandemic and tomorrow’s challenges. It’s more important than ever that we continue our efforts to modernize the way we treat the world’s most vexing diseases,” DeGette and Upton said. “Our new bipartisan legislation will build on the successes of 21st Century Cures and help us take the next step toward finding and delivering more life-saving cures for patients in Michigan, Colorado, and across the country.”
Since the lawmakers announced they were starting to work on this new bill, they have received nearly 500 comments from stakeholders. Based on that feedback, they expect Cures 2.0 to cover six key areas:
· PUBLIC HEALTH AND PANDEMIC PREPAREDNESS: Among other things, the lawmakers are exploring ways to improve our nation’s pandemic surveillance and testing capabilities, support antimicrobial resistance product commercialization and expand vaccine education and surveillance. They are also considering ways to create a COVID-19 Rare Disease Support Program and establish a federal grant program to help patients and their families afford the cost of medical care involving pandemics.
· CAREGIVER INTEGRATION: With many Americans receiving care at home, lawmakers are considering how Cures 2.0 could create educational programs and training for caregivers to learn skills. This could help them to augment a care team and complement, not compete with, a clinical visit.
· PATIENT ENGAGEMENT IN HEALTH CARE DECISION-MAKING: Another goal of Cures 2.0 will likely be improved health literacy and access to health information. The goal of these provisions would be to help patients better understand their diseases or conditions, and thus empower them to become part of the decision-making process and take steps to get well.
· DIVERSITY IN CLINICAL TRIALS: Diversity in clinical trials is essential to ensuring medical products are safer and more effective for patients. The lawmakers are exploring provisions that could help ensure that regulators, industry, patients and researchers continue to improve diversity. This could also help improve access to already covered medical services at clinical trial sites.
· FOOD AND DRUG ADMINISTRATION MODERNIZATION: While the first Cures Act took steps to foster the development of digital health technologies, including at FDA, through inclusion of the Software Act, the lawmakers believe Cures 2.0 can help ensure that FDA’s regulatory framework is collaborative and inclusive of the various centers within the agency. DeGette and Upton also hope the legislation could help enable FDA to provide grants in the area of innovative clinical trial design and patient-focused drug development to further build the science in these areas. Another goal of Cures 2.0 is to speed up the development and utilization of real-world data (RWD) and real-world evidence (RWE).
· CMS MODERNIZATION: Modernizing coverage and care delivery in the United States is another top priority for DeGette and Upton. In order to do this, DeGette and Upton are seeking additional stakeholder feedback on how the U.S. can keep pace with technological and scientific advances, and what specific provisions must be included in the final Cures 2.0 package.
DeGette and Upton introduced the first 21st Century Cures Act in the House on May 19, 2015. It was passed in the House with strong bipartisan support on July 10, 2015 and signed into law by President Obama on December 13, 2016. Click here for more information on 21st Century Cures.“Thanks to Cures, we’re able to better prevent and screen cancer, we have a better understanding of the human brain, and we’re improving the field of stem cell science. We’ve seen a record number of new drugs approved, including new generics, which have helped lower health care costs for millions of Americans. And we’re on the cusp of finding a cure for sickle cell,” DeGette and Upton said. “But despite these successes, there’s still much more work to be done.”