Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) introduced the Cures 2.0 Act (H.R. 6000) on Nov. 15, a bill aimed at accelerating medical research and patient access to novel therapeutics. This formal introduction incorporates stakeholder feedback, including from the AAMC, to the June 22 discussion draft of the bill [refer to Washington Highlights, June 25, July 23].
The introduced bill removed a placeholder to add text to authorize President Joe Biden’s Advanced Research Projects Agency for Health (ARPA-H) proposal. “Diseases such as cancer, diabetes, Alzheimer’s and ALS don’t care if you’re a Democrat or Republican. They affect all of us the same. By creating ARPA-H, we will be bringing together some our nation’s greatest minds to help find cures to these devastating diseases,” DeGette and Upton said in a press statement.
Cures 2.0 would establish ARPA-H within the National Institutes of Health (NIH), as proposed by Biden and both House and Senate Appropriations Committees in their draft fiscal year (FY) 2022 spending bills. The bill would provide $6.5 billion for ARPA-H in FY 2022, to be available until expended.
The Cures 2.0 proposal would establish the ARPA-H director as a presidential appointee with a five-year term. The director would have authority to approve and terminate project funding, establish milestones, and coordinate with other federal research agencies.
The bill would require coordination between ARPA-H and other federal agencies to avoid duplication of efforts and would allow the director to seek advice from existing federal advisory committees or other external experts.
Rep. Anna Eshoo (D-Calif.) also introduced a stand-alone bill to authorize ARPA-H, the Advanced Research Project Agency-Health (ARPA-H) Act (H.R. 5585), on Oct. 15 [refer to Washington Highlights, Oct. 22]. While supporting similar research initiatives and structures for personnel, Eshoo’s bill would establish ARPA-H outside of the NIH and would provide $3 billion in funding beginning in FY 2022, while allowing for advanced appropriations in future years.
The introduced bill retains the provision to make permanent current telehealth waivers that were included in the discussion draft.
In the updated bill text, DeGette and Upton incorporated many of the AAMC’s previous recommendations on other parts of the discussion draft by adding new provisions and refining others, including:
- A reauthorization of the Research Policy Board and inclusion of the NIH director as a member of the board.
- Investments in better addressing Long-COVID-19 including a requirement for the NIH to conduct additional research in children, a National Academies study to evaluate disparities, and public and provider education programs.
- Language to avoid duplication of new grant programs with existing educational programs and training for caregivers.
- Improved interagency communication regarding enhanced approval of transformative new therapies, ensuring that approval processes for the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services remain separate and distinct.
- A requirement for the FDA to consider recommendations to decentralize clinical trials.
- Language reinforcing protections for Medicare beneficiaries regarding access to breakthrough technology.
DeGette and Upton have indicated they would like to pass the Cures 2.0 Act as quickly as possible, but next steps for committee consideration are unclear.