Upton and DeGette Begin Work on Cures Act Reprise

Regulatory NewsRegulatory News | 25 November 2019 |  By 

Three years after the passage of the 21st Century Cures Act, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are starting work on a version 2.0 of the bill with a focus on access to new medicines, digital health and furthering the use of real-world evidence (RWE) by the US Food and Drug Administration (FDA).
In a two-page call to action paper, DeGette and Upton ask for input on how to address those and other healthcare challenges in a future legislative package by 16 December 2019.
“We are so proud of what the first effort of 21st Century Cures has been able to achieve in such a short amount of time, but one thing we have heard from listening to folks across the nation is that we need to do more to promote access to these life-saving cures,” DeGette and Upton said. “There are still too many patients without a treatment, and we need to do everything we can to help them now.”
However, even as they begin work on a new version of Cures, FDA and other federal agencies are still working to complete deliverables required under the original bill. For FDA, some of those upcoming deliverables include issuing final guidance on combination product innovation and patient-focused drug development in the coming year.
Based on the call to action document, Cures 2.0 looks to be more restricted in scope than the wide-ranging original act, which included provisions affecting dozens of programs at FDA and other agencies under the Department of Health and Human Services.
In the vision for Cures 2.0, the biggest area that would impact FDA is a proposal to build on the RWE provisions of the first Cures, which called on FDA to develop a framework and issue guidance on RWE. “We would like to build on our initial RWE work, both at FDA and across the federal health care landscape,” DeGette and Upton write.
They also say they want to improve coverage of digital health products and services by healthcare payers, including Medicare.
“Digital technologies have helped to transform other sectors of the US economy in ways that improve access to products and services and decrease their costs without harming quality. It is time for that same transformation to occur in health care,” DeGette and Upton write.
The representatives also want to address the lag between when new medical products are approved and when health insurers, Medicare and Medicaid offer coverage for them, noting that coverage is often more challenging for products developed for smaller populations.
Press Release, Call to Action


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