Draft Legislation Would Create ARPA-H as Part of Cures 2.0
U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) have released draft legislation that would create an Advanced Research Projects Agency for Health, or ARPA-H, and authorize the more than $6.5 billion the White House says it needs to run the agency. The bill is expected to become part of a larger Cures 2.0 legislation, a follow-up to the 21st Century Cures Act.
The legislation coincides with a concept paper the White House published in Science Magazine outlining their vision for the new research agency. 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
DeGette and Upton noted that it wouldn’t be the first time the DARPA model is applied to biomedical research. It was DARPA that initially funded Moderna’s mRNA vaccine technology when other agencies were skeptical of the approach; an investment that later led to the development of a highly effective COVID-19 vaccine in record time that’s helped stop the spread of the virus both in the U.S. and abroad.
According to a fact sheet produced by the White House, further developing that mRNA vaccine technology to prevent most cancers is one of the projects ARPA-H could undertake.
Unlike other federally funded biomedical research programs, ARPA-H would be run by a relatively small number of program managers who would be given a much higher degree of autonomy to choose which projects to fund – allowing them to pursue high-risk, high-reward projects that other agencies would likely shy away from.
DeGette and Upton, who have been working with the White House for months to make the new entity a reality, have included the language needed to create it in a broader bill the pair has been working on for over a year to modernize how the U.S. delivers innovative new cures and treatments to patients.
That bill, known as Cures 2.0, seeks to build upon earlier legislation they sponsored in 2015, the 21st Century Cures Act.
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.
In addition to creating ARPA-H, the Cures 2.0 legislation would seek to :
• Improve how Medicare covers innovative new healthcare technologies, making them more available to those who need them.
• 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.
• Provide training and educational programs for caregivers – many of whom are often family members with no prior health care experience – to help improve the quality of care patients are provided at home, between clinical visits.
• Provide patients greater access to more health information to improve their understanding of the illness they face and make them a more integral part of the decision-making process when assessing which course of treatment is best for them.
• Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.
The legislation would also require the secretary of Health and Human Services to conduct a nationwide study to further understand the implications of long COVID, a condition that causes patients to experience a range of symptoms related to COVID-19 for weeks, and even months, after contracting the virus. And it calls on the secretary to develop a nationwide testing and vaccine distribution strategy to be used in future pandemics.
