Bill Overview
Title: ARPA–H Act
Description: s Agency-Health Act or the ARPA-H Act This bill establishes within the Department of Health and Human Services (HHS) the Advanced Research Projects Agency-Health to accelerate health and medical innovation by investing in high-risk, high-reward research. The bill also establishes a committee to advise on agency activities. HHS must transfer all authorities, functions, funds, and personnel from a similar entity within the National Institutes of Health to a new, independent agency. Additionally, the President must appoint a director to lead the agency. The director may submit testimony and recommendations concerning the agency to Congress without review or approval by other federal officers or agencies. The director must appoint personnel to administer the agency's research programs, including by selecting projects to support and making recommendations about terminating or continuing projects. The agency may use grants, prize competitions, and a variety of other mechanisms to support the research projects. The agency's budget is separate from that of HHS. The agency must coordinate with the Food and Drug Administration and the Centers for Medicare & Medicaid Services to expedite development and coverage of high-need cures. Additionally, the agency may partner with other public and private entities (e.g., institutions of higher education and patient advocacy organizations). The bill also requires the agency to develop and periodically update a strategic plan and annually report on its activities. Furthermore, (1) the National Academies of Sciences, Engineering, and Medicine must evaluate the agency's performance; and (2) the Government Accountability Office must review the research portfolio of HHS and its components, including the new agency.
Sponsors: Rep. Eshoo, Anna G. [D-CA-18]
Target Audience
Population: People whose wellbeing might be impacted by health and medical innovations from ARPA-H
Estimated Size: 330000000
- The establishment of ARPA-H aims to accelerate health and medical innovation, potentially impacting the entire global population by developing new health solutions.
- High-risk, high-reward research can lead to breakthroughs in treating or curing diseases, affecting people suffering from ailments worldwide.
- Coordination with the FDA and CMS aims to expedite cures for high-need diseases, indicating a focus on diseases with significant unmet medical needs.
- Patients in the U.S. might be the first beneficiaries of any new treatments and innovations due to the localization of the agency.
- Partnerships with public and private entities, including international ones, suggest a global impact of research outcomes.
- Investments in health innovation can lead to long-term benefits in global health, potentially improving health outcomes for billions of people.
Reasoning
- ARPA-H is expected to influence a wide array of individuals primarily in the U.S. with potential global impacts through health innovations aimed at high-need diseases.
- Budget restrictions imply that immediate impacts would be most focused on individuals relating to or impacted by diseases with high unmet needs, possibly those within research fields, patients awaiting treatments, healthcare professionals, etc.
- The initial budget allows for significant projects, but these must be prioritized. Large-scale, immediate breakthroughs may be limited by budget constraints, leading to more selective beneficiary targeting in the early stages.
- Understanding the policy's impact requires a range of perspectives, including those directly involved in the healthcare and research industries, patients, and more tangentially related individuals.
Simulated Interviews
Biomedical researcher (San Francisco, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- I'm hopeful this agency will fuel more innovative research projects that might not have been funded previously.
- The independence from NIH is interesting, but it will depend on how well the agency executes its goals.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 10 | 8 |
| Year 20 | 10 | 8 |
Oncologist (Houston, TX)
Age: 58 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- This could be transformative for patients with rare conditions who currently have limited options.
- There's always a concern about how long new approvals take, but this initiative might speed that up.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Graduate student in biochemistry (Boston, MA)
Age: 24 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- Excited about the possibility of more diverse funding options for risky projects.
- The agency's coordination with FDA could mean faster paths from research to treatment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Patient advocate (Phoenix, AZ)
Age: 32 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 18/20
Statement of Opinion:
- I'm optimistic that new breakthroughs from this agency could mean better outcomes for the individuals we represent.
- The agency's partnership with advocacy groups is a step in the right direction.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 9 | 6 |
Retired engineer (Miami, FL)
Age: 64 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 20/20
Statement of Opinion:
- I'm cautiously hopeful that this agency might support research that prevents or alleviates common age-related diseases.
- It's crucial that the projects funded lead to tangible treatments, not just theoretical research.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 4 |
Health policy advisor (Chicago, IL)
Age: 39 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 9/20
Statement of Opinion:
- The strategic plan will be critical; aligning projects with societal needs is vital.
- We need to see if this encourages novel preventive measures as much as it does curative research.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Primary care physician (Rural Kansas)
Age: 28 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 8/20
Statement of Opinion:
- Mastering the challenge of chronic illness through new innovations could really improve lives here.
- I'm hopeful but unsure how quickly any benefits would manifest in rural areas.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 9 | 6 |
Pharmaceutical executive (New York, NY)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- It could change the investment landscape by lowering the risk of early-stage innovations.
- I'm interested to see how public-private partnerships evolve with this initiative.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Software engineer (Los Angeles, CA)
Age: 30 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 14/20
Statement of Opinion:
- I'm hopeful for any progress that helps uncover new treatments for rare conditions.
- Coordination with patient advocacy could mean voices like mine are heard in how research is prioritized.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 6 |
Environmental health and safety officer (Seattle, WA)
Age: 55 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 4/20
Statement of Opinion:
- Excited about potential indirect benefits of biotechnological innovations on environmental health.
- Understanding long-term impacts and holistic views in health innovations is critical.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Cost Estimates
Year 1: $5000000000 (Low: $4000000000, High: $6000000000)
Year 2: $5500000000 (Low: $4500000000, High: $6500000000)
Year 3: $6000000000 (Low: $5000000000, High: $7000000000)
Year 5: $6500000000 (Low: $5500000000, High: $7500000000)
Year 10: $7000000000 (Low: $6000000000, High: $8000000000)
Year 100: $5000000000 (Low: $4000000000, High: $6000000000)
Key Considerations
- The bill aims to establish an agency modeled on DARPA, suggesting potential high-cost structures but also significant innovation outcomes.
- Coordination with FDA and CMS could necessitate regulatory adjustments, affecting cost and time to market for innovations.
- Effectiveness and efficiency of the agency's strategic plan and its alignment with the broader goals of HHS are crucial.