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# Bipartisan ‘Cures 2.0’ Concept Paper Out
- URL: https://www.fdaweb.com/bipartisan-cures-2-0-concept-paper-out/
- Published: 2020-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:13:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146678

Reps. **Diana DeGette** (D-CO) and **Fred Upton** (R-MI) have released a concept paper for their bipartisan “Cures 2.0.” The two say the paper looks at high levels of focus for Cures 2.0, which will look to safely and efficiently modernize the delivery of healthcare in the wake of the coronavirus pandemic. They introduced the first 21st Century Cures Act on 10/15/19.

DeGette and Upton say they expect Cures 2.0 to cover six areas: public health and pandemic preparedness, caregiver integration, patient engagement in healthcare decision-making, diversity in clinical trials, FDA modernization, and CMS (Centers for Medicare and Medicaid Services) modernization.

Concept paper ideas relating to FDA are: 

- require FDA to provide an update on the implementation of its action plan on clinical trial diversity required under the FDA Safety and Innovation Act;
- participate in an HHS task force on making ClinicalTrials.gov more user- and patient-friendly;
- work with CMS and the National Institutes of Health to improve access to already covered medical services at clinical trial sites
- require the FDA commissioner to work with CDER, CBER, and CDRH to establish a collaborative regulatory alignment on digital technology where advisable;
- provide funds to enable FDA to provide grants in the area of innovative clinical trial design and patient-focused drug development to further build the science in those areas
- require FDA to issue a guidance on using real-world evidence in breakthrough designation and accelerated approval products as part of post-approval commitments;
- require FDA to participate in a task force with patient groups, CMS, and private sector representatives to develop recommendations on ways to encourage patients to engage in generating real-world data; and
- establish an automatic communication requirement between FDA and CMS for products granted breakthrough designation to start at the time the designation is granted and continue through the collection of any real-world evidence after FDA approval.