In 2016, the U.S. Congress passed the 21st Century Cures Act, landmark legislation overhauling the development of medical treatments and cures for patients.
Alliance Comments on 21st Century Cures Act 2.0 Draft Legislation
Published July 16, 2021
July 16th, 2021 – Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) recently released a discussion draft of the 21st Century Cures 2.0 Act (Cures 2.0).
Broadly, Cures 2.0 would bolster funding for vaccine and immunization programs, encourage investment in new antimicrobial drugs, expand collection of patient experience data in clinical trials, promote the use of real-world evidence, and establish coverage for breakthrough medical devices. Additionally, the bill would create two new disease Centers of Excellence at the FDA and authorize the creation of the Advanced Research Projects Agency for Health (ARPA-H) to fund transformational research. ARPA-H was first proposed in President Biden’s 2022 budget proposal.
In the letter, the Alliance indicated support for many provisions in Cures 2.0, while encouraging changes to:
- Promote inclusion of older adults by creating a policy for the FDA similar to the Inclusion Across the Lifespan policy at the National Institutes of Health (NIH), that requires a for plan for including individuals across the lifespan and the justification of exclusions based on age.
- Increase transparency and access to data in patient registries for the Centers for Medicare and Medicaid Services (CMS) and the public
- Support for the new Centers of Excellence at the FDA, and designation of one of the centers to focus on neuroscience
- Clarify standards around CMS coverage with evidence development status
- Ensure that ARPA-H complements current research efforts at the NIH and supports transformational research.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org