AAMC Chief Public Policy Officer Karen Fisher, JD, offered the affiliation’s suggestions to the latest discussion draft of the Cures 2.0 Act by two separate letters on July 19. The draft laws, authored by Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), is aimed toward accelerating medical analysis and affected person entry to novel therapeutics [refer to Washington Highlights, June 25] as a follow-up to their 2016 twenty first Century Cures Act.
One of the 2 letters responds to a request for info (RFI) issued along side the dialogue draft, searching for enter on numerous questions relating to President Joe Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H). The draft invoice features a placeholder for ARPA-H however doesn’t define specs. The AAMC letter emphasised the significance of making certain that the institution of ARPA-H would complement — and never detract from — the National Institutes of Health (NIH) as it’s presently configured, together with making certain strong, sustained investments within the foundational science NIH helps.
That letter additionally proposed establishing a committee of scientific and different specialists that may have the authority to evaluation analysis portfolios at common intervals to consider progress on the chosen tasks. This panel would increase the experience of ARPA-H program managers and supply extra “checks” to be certain that assets are expended correctly. “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 alternatives for ARPA-H to construct on particular successes of the Defense Advanced Research Projects Agency; the extra impression of supporting analysis relevant throughout scientific disciplines and illness states; the function of ARPA-H in balancing independence from and collaboration with present businesses, trade, and academia; and the significance 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 dialogue draft with a concentrate on funding for medical analysis. The letter thanked Congress for its continued bipartisan dedication to elevated funding for the NIH, together with six years of above-inflation will increase for the company.
“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,” mentioned 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” relating to the president’s ARPA-H proposal. The collection of greater than 10 periods launched on July 14 and can proceed by mid-August.
In a separate letter, the AAMC responded to the rest of DeGette and Upton’s Cures 2.0 dialogue draft, together with feedback on provisions associated to:
- Research, together with appreciation for the inclusion of the Research Investment to Support the Economy Act that’s meant to mitigate COVID-19’s impression on medical analysis and the workforce [refer to Washington Highlights, Feb. 5].
- Public well being, specializing in the implications of lengthy COVID-19; enhancing nationwide testing, vaccine, and response methods for future pandemics; and addressing antimicrobial resistance.
- Patients and caregivers, commenting on enhancing affected person well being and digital literacy, growing range in scientific trials, and supporting protection of scientific trials funded by the Patient-Centered Outcomes Research Institute.
- The U.S. Food and Drug Administration (FDA), together with alternatives to equitably enhance digital well being expertise utilization, incorporate real-world proof within the drug approval course of, and improve communication between the FDA and different well being businesses.
- The Centers for Medicare & Medicaid Services, together with growing telehealth utilization and lengthening telehealth flexibilities, protection for revolutionary applied sciences and breakthrough units, and entry and protection of genetic testing and precision drugs interventions.
- Other issues, together with the institution of the Research Policy Board beneficial within the twenty first Century Cures Act (P.L. 114-255), assist for analysis classes realized from COVID-19, and federal funding for doctor coaching.
DeGette and Upton are anticipated to launch an up to date model of the Cures 2.0 Act following Congress’ August recess.