Bill Overview
Title: 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: Rep. O'Halleran, Tom [D-AZ-1]
Target Audience
Population: Individuals whose health and wellbeing may be impacted by medical product innovation
Estimated Size: 331000000
- The Critical Path Public-Private Partnerships aim to accelerate the process of FDA review for new medical products, which can make these products available more quickly.
- Medicines and medical product development affect both the patients who will use them as well as the developers and researchers involved.
- This will likely impact populations needing medical treatments, such as patients with chronic illnesses or rare diseases, as well as general populations who could benefit from medical advancements.
- Developers, manufacturers, and researchers in the pharmaceutical and medical device industries will be directly impacted by changes in regulations and funding opportunities through the FDA partnerships.
- The total global population could be impacted as faster approval processes may lead to quicker global distribution of new medical innovations.
Reasoning
- Medical product innovation largely influences individuals who could directly benefit from new treatments available through accelerated review processes.
- Not every American will feel the direct impact of the policy, but those within certain groups, such as patients with chronic or rare diseases or those focused on innovative medical procedures, will likely benefit.
- Researchers and developers in the biomedical field will experience changes in opportunities and processes, which may influence job satisfaction and productivity.
- Considering the policy's budget constraints, the reach could be vast in terms of potential impact on drug and device availability, but would be more focused on individuals in immediate need or involved in creation and regulation.
- The policy will not directly change the everyday life of all Americans immediately, but the perceived long-term health benefits could be significant.
- Individuals aware and informed about medical innovations likely will feel more optimistic when knowing that the regulatory processes are being streamlined for modern healthcare solutions.
Simulated Interviews
Medical Researcher (Boston, MA)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy seems very promising as it might fast-track our drug approvals.
- In the long-term, it could increase our funding opportunities and improve workplace optimism.
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 | 6 |
| Year 20 | 7 | 6 |
Biomedical Engineer (Austin, TX)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- FDA processes are quite slow, any speed-up is welcome.
- Policy could enable us to get our devices to market quicker, benefitting patients sooner.
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 | 6 |
Patient with Chronic Illness (San Francisco, CA)
Age: 29 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- New treatments can't come fast enough for people like me.
- The policy might make a huge difference in our lives if it speeds up access to innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 7 | 5 |
Retired (New York, NY)
Age: 67 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- As an older patient, faster approval for new medical devices and treatments could positively impact my health management.
- I hope this policy also means more innovative solutions soon.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 5 | 5 |
Health Policy Analyst (Seattle, WA)
Age: 34 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Public-private partnerships are crucial for innovation, if done transparently and safely.
- This policy aligns with improving regulatory frameworks and I support it.
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 | 8 | 8 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Retired Nurse (Miami, FL)
Age: 74 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- While speeding up approvals is great, patient safety must remain the priority.
- I'm cautiously optimistic about this policy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 5 |
Biotech Entrepreneur (Chicago, IL)
Age: 45 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- Policies like this are pivotal for startups like ours to survive in the competitive biotech landscape.
- Potential lower barriers and cooperation could significantly boost innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
Tech Developer in Health Apps (Atlanta, GA)
Age: 25 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Improvements in medical technology approvals could benefit our app development processes.
- Speedy approval means we can incorporate the latest tech into our work quickly.
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 | 8 | 8 |
| Year 10 | 7 | 7 |
| Year 20 | 6 | 6 |
Pharmaceutical Sales Rep (Houston, TX)
Age: 52 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Policy could mean a surge in the variety of products available for us to market.
- Faster approvals echo excitement and boost in business operations.
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 | 8 | 7 |
| Year 20 | 6 | 6 |
Insurance Underwriter (Los Angeles, CA)
Age: 39 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- Accelerated approval could impact insurance claims and coverage policies.
- Initial concerns about the cost of new innovations on insurance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 5 | 5 |
Cost Estimates
Year 1: $150000000 (Low: $130000000, High: $170000000)
Year 2: $155000000 (Low: $135000000, High: $175000000)
Year 3: $160000000 (Low: $140000000, High: $180000000)
Year 5: $170000000 (Low: $150000000, High: $190000000)
Year 10: $180000000 (Low: $160000000, High: $200000000)
Year 100: $250000000 (Low: $220000000, High: $280000000)
Key Considerations
- Reauthorization is a continuation not an entire overhaul, so minimal disruption in current processes.
- Potential increases in efficiency and yield in FDA approvals can directly affect health outcomes.
- Inflation and changes in public-private research trends could affect actual costs.
- International impacts are significant given the FDA's global influence on regulatory standards.