Washington Update

CURES 2.0 Bill Contains New ARPA-H Guidelines

By: Kyle Cavagnini
Thursday, December 2, 2021
On November 17, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the bipartisan Cures 2.0 Act (H.R.6000), which is designed to revolutionize care to patients and change how biomedical research is conducted as a follow on to their successful 21st Century Cures Act enacted into law in 2016. A section-by-section summary of their current bill can be found here

Section 501 under Title V, Research in Cures 2.0, provides an updated framework for the Advanced Research Projects Agency for Health (ARPA-H). This agency, to be located within National Institutes of Health (NIH), will fund high-risk high-reward projects addressing the most pressing biomedical needs of the country, including cancer, diabetes, and Alzheimer’s disease. Cures 2.0 appropriates $6.5 billion to ARPA-H for the 2022 fiscal year. The agency, overseen by a presidentially appointed director, will employ program officers to manage portfolios consisting of multiple projects which work toward a common target.  Projects will be selected based on their novelty, scientific merit, potential for future commercialization, and the unmet needs within patient populations. Funding multiple projects that coalesce around a shared goal increases the chances of success. 

ARPA-H will have broad leeway to forge research and development partnerships with other federal agencies, public and private research institutions, commercial entities, and nonprofit organizations. This is key to the ARPA-H goal of delivering promising new treatments to patient populations and developing new infrastructure to enhance biomedical research.  Cures 2.0 directs the secretary of the U.S. Department of Health and Human Services to coordinate with U.S. Food and Drug Administration to expedite review of clinical products produced from ARPA-H research.

Earlier this year Rep. Anna Eshoo (D-CA), chair of the House Energy and Commerce’s Subcommittee on Health, introduced a standalone ARPA-H bill, ARPA-H Act (H.R.5585). The duties of the director and program managers and criteria for project selection are comparable between the two bills. Both bills also mandate the director make efforts to recruit and retain a diverse workforce, including individuals underrepresented in science and medicine. Cures 2.0 and the ARPA-H Act specify that the agency will be funded independent of the existing NIH budget allocations, an issue the biomedical research community said was important during stakeholder listening sessions earlier this year. 

Several key differences exist between the two proposed ARPA-H frameworks. Notably, the ARPA-H Act only appropriates $3 billion to the agency. The ARPA-H Act also includes a deputy director to assist the director and serve as acting director if needed. Procedures for the strategic plan timeline, annual reporting, and budget requests to Congress also differ between the bills. The ARPA-H Act calls for a review of the program by the National Academies of Sciences, Engineering, and Medicine within eight years of the bill’s enactment, a provision not found in Cures 2.0.