AAMC Chief Public Policy Officer Karen Fisher, JD, provided the association’s feedback to the recent discussion draft of the Cures 2.0 Act through two separate letters on July 19. The draft legislation, authored by Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), is aimed at accelerating medical research and patient access to novel therapeutics [refer to Washington Highlights, June 25] as a follow-up to their 2016 21st Century Cures Act.
One of the two letters responds to a request for information (RFI) issued in conjunction with the discussion draft, seeking input on various questions regarding President Joe Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H). The draft bill includes a placeholder for ARPA-H but does not outline specifications. The AAMC letter emphasized the importance of ensuring that the establishment of ARPA-H would complement — and not detract from — the National Institutes of Health (NIH) as it is currently configured, including ensuring robust, sustained investments in the foundational science NIH supports.
That letter also proposed establishing a committee of scientific and other experts that would have the authority to review research portfolios at regular intervals to evaluate progress on the selected projects. This panel would augment the expertise of ARPA-H program managers and provide additional “checks” to ensure that resources are expended wisely. “As lawmakers and the Administration consider how ARPA-H might supplement and build upon the work currently supported by NIH, we urge you to keep in mind the principles underlying the scientific processes that have served the NIH as the world’s gold standard for decades,” Fisher wrote.
Additionally, the letter responds to questions on opportunities for ARPA-H to build on specific successes of the Defense Advanced Research Projects Agency; the additional impact of supporting research applicable across scientific disciplines and disease states; the role of ARPA-H in balancing independence from and collaboration with existing agencies, industry, and academia; and the importance of a funding stream separate from the yearly NIH appropriation.
The Ad Hoc Group for Medical Research, convened by the AAMC, also provided feedback on the discussion draft with a focus on funding for medical research. The letter thanked Congress for its continued bipartisan commitment to increased funding for the NIH, including six years of above-inflation increases for the agency.
“As you consider how to establish ARPA-H, the Ad Hoc Group urges you to work with appropriators to ensure that investments in ARPA-H are balanced with robust investment in NIH-supported, foundational, investigator-initiated research. … There is room in this ecosystem for both advanced R&D approaches like ARPA-H and foundational science that is the core of NIH’s mission, but — critically — the former depends on the latter,” said Ad Hoc Group Executive Director Tannaz Rasouli.
Meanwhile, the NIH and White House Office of Science and Technology Policy have organized a series of listening sessions “to get feedback from patient advocacy groups, industry, scientific professional organizations, and other stakeholders” regarding the president’s ARPA-H proposal. The series of more than 10 sessions launched on July 14 and will continue through mid-August.
In a separate letter, the AAMC responded to the remainder of DeGette and Upton’s Cures 2.0 discussion draft, including comments on provisions related to:
- Research, including appreciation for the inclusion of the Research Investment to Support the Economy Act that is intended to mitigate COVID-19’s impact on medical research and the workforce [refer to Washington Highlights, Feb. 5].
- Public health, focusing on the implications of long COVID-19; enhancing national testing, vaccine, and response strategies for future pandemics; and addressing antimicrobial resistance.
- Patients and caregivers, commenting on improving patient health and digital literacy, increasing diversity in clinical trials, and supporting coverage of clinical trials funded by the Patient-Centered Outcomes Research Institute.
- The U.S. Food and Drug Administration (FDA), including opportunities to equitably increase digital health technology utilization, incorporate real-world evidence in the drug approval process, and enhance communication between the FDA and other health agencies.
- The Centers for Medicare & Medicaid Services, including increasing telehealth utilization and extending telehealth flexibilities, coverage for innovative technologies and breakthrough devices, and access and coverage of genetic testing and precision medicine interventions.
- Other considerations, including the establishment of the Research Policy Board recommended in the 21st Century Cures Act (P.L. 114-255), support for research lessons learned from COVID-19, and federal funding for physician training.
DeGette and Upton are expected to release an updated version of the Cures 2.0 Act following Congress’ August recess.