Proposed Cures 2.0 Act May Have Implications for Researchers
Members of the U.S. House of Representatives have introduced updates to the 21st Century Cures Act, which was signed into law in December 2016. The proposed legislation coincides with a detailed concept paper the White House published Tuesday in Science Magazine outlining their vision for the new research agency.
The 21st Century Cures Act, known as “Cures”, was initiated to modernize the U.S. healthcare system. The far-reaching law included provisions to advance precision medicine, accelerate the development of new medical products, and bring new innovations to patients more efficiently.
The new bill, called the Cures 2.0 Act would create an Advanced Research Projects Agency for Health, or ARPA-H, and would authorize more than $6.5 billion to run the agency. The mission of ARPA-H will be to speed transformational innovation in health research and speed application and implementation of health breakthroughs.
Under the terms of the lawmakers’ proposal, the new ARPA-H would be largely modeled after the military’s Defense Advanced Research Projects Agency, or DARPA, which has been responsible for successfully developing some of the most significant technological advancements of our time, including the Internet, GPS and self-driving cars. DARPA initially funded mRNA vaccine technology, which led to the development of a highly effective COVID-19 vaccine in record time that’s helped slow the spread of the virus both in the U.S. and abroad.
While the 21st Century Cures Act sought to improve how new drugs and treatments are researched and developed in the U.S., Cures 2.0 seeks to improve how those new treatments and therapies are delivered to patients.
The bill provides $25 billion to independent research institutions, public laboratories and universities throughout the country to continue their work on thousands of federally-backed projects. In addition to the funding, some of the sections of the legislation will have direct implications for researchers, specifically:
- Increase diversity in clinical trials.
- Require FDA to expand the collection and use of “real world evidence” to aid in the development of new, patient-focused treatment approaches.
- Require study sponsors to collect patient experience data in clinical trials.
- Ensure coverage for clinical trials under existing standard of care: allows Medicare to cover the costs of their beneficiaries in PCORI-funded clinical trials
- Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) — possibly opening opportunities for more remote clinical trials.
- Provide grants for innovative clinical trial design and patient experience data to further build the science in these areas.
- Minimize or remove requirements for IND applications to initiate accelerated approval if sponsors meet proper criteria.
- Allow for use of evidence such as clinical evidence, patient registries, or other real-world evidence, to fulfill post approval study requirements to confirm the predicted clinical benefit of a therapy.
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) plan to hold roundtables about their proposal in June and July with the aim of releasing a final bill after Congress returns from its August break, according to reports.
ARPA-H Fact Sheet (https://upton.house.gov/uploadedfiles/final_cures_2.0_2-pager.pdf)
A section-by-section summary of the bill https://degette.house.gov/sites/degette.house.gov/files/Cures%202.0_DD%20SxS_FINAL1.pdf
Article published in Science (https://science.sciencemag.org/content/early/2021/06/22/science.abj8547)