Bill Overview
Title: A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Critical Path Public-Private Partnerships.
Description: This bill reauthorizes through FY2027 the Food and Drug Administration's Critical Path Public-Private Partnerships, which support medical product innovation, development, and safety.
Sponsors: Sen. Kelly, Mark [D-AZ]
Target Audience
Population: Individuals impacted by medical product innovations, healthcare providers, and industry participants globally
Estimated Size: 330000000
- The Critical Path Public-Private Partnerships aim at fostering medical product innovation, which typically impacts innovators in the biotech and pharmaceutical sectors, as well as healthcare providers and patients who benefit from improved medical products.
- Globally, there are millions of patients who would be potential recipients of new and innovative medical treatments supported by such partnerships.
- Biotechnology and pharmaceutical companies globally will benefit from continued innovation support.
- The global healthcare sector, including hospitals, clinics, and healthcare workers, will indirectly benefit from improved medical product safety and efficacy.
Reasoning
- Given the policy aims to support medical product innovation through public-private partnerships, the direct impact would be more significant on those working in the pharmaceutical, biotech, and healthcare sectors who are involved with drug innovation, development, and regulation.
- Indirect beneficiaries include patients who might eventually receive enhanced medical products leading to better health outcomes, though these effects might be seen over a more extended period.
- This policy, while impactful on a global scale, will require substantial funding to visibly affect the end-users like patients in terms of new treatments reaching the market quickly.
- Considering a budget of $100,000,000 in year 1 and $775,543,750 over 10 years, the budgetary constraints mean selecting critical projects and possibly a focus on harmony with other initiatives to maximize impact.
- The diversity of impact (from high-profile pharmaceutical companies to individual patients who might not feel the full effects for several years) leads to a varied distribution of Cantril wellbeing scores.
Simulated Interviews
Biotech Research Scientist (San Francisco, CA)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm hopeful that with continued funding, we can push through some significant advances in treatment for rare diseases.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 9 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 10 | 7 |
| Year 20 | 9 | 7 |
Pharmaceutical Executive (Boston, MA)
Age: 54 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Maintaining these partnerships is crucial for sustained innovation in our sector.
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 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Clinical Trials Coordinator (Austin, TX)
Age: 63 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This funding helps ensure we continue our trials without interruption.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Patient Advocate (Chicago, IL)
Age: 35 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 6/20
Statement of Opinion:
- Innovations can make existing treatments more effective or access to new treatments possible.
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 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Cardiologist (Miami, FL)
Age: 47 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- While directly I don't see an immediate change in my day-to-day, knowing better treatments are on the horizon is reassuring.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 7 |
Healthcare Policy Analyst (Los Angeles, CA)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Government involvement in public-private partnerships is essential to address gaps in health innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 7 |
Software Engineer in Health Tech (Seattle, WA)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- More funding means we can collaborate on projects to improve patient-centric software solutions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 7 |
Retired, former pharmaceutical researcher (New York, NY)
Age: 62 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- I see the importance, but any benefits will take years to materialize.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Pediatric Nurse (Houston, TX)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 11/20
Statement of Opinion:
- Policies supporting innovation could bring new hope for treatment-resistant cancers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Hospital Administrator (Phoenix, AZ)
Age: 48 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 12/20
Statement of Opinion:
- This funding may streamline our processes with newer medication options and protocols in future.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $100000000 (Low: $90000000, High: $120000000)
Year 2: $105000000 (Low: $95000000, High: $125000000)
Year 3: $110250000 (Low: $99750000, High: $130000000)
Year 5: $115762500 (Low: $105375000, High: $136500000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Continued support for medical innovation is critical for maintaining the pace of technological advancement in healthcare.
- Balancing the costs and expected advancements remains integral; monitoring and evaluating the program's outcomes will be vital to justifying future funding allocations.