Bill Overview
Title: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.
Description: This bill requires the Food and Drug Administration (FDA) to report to Congress on barriers to the domestic manufacturing of imported active pharmaceutical ingredients, finished drug products, and devices that are critical to public health. The report must recommend strategies to overcome such barriers. The FDA may, to the extent appropriate, implement the strategies.
Sponsors: Rep. Herrell, Yvette [R-NM-2]
Target Audience
Population: People dependent on pharmaceutical products and medical devices
Estimated Size: 300000000
- The bill aims to improve domestic manufacturing capabilities, which could affect pharmaceutical companies and their employees in the U.S.
- Improving domestic manufacturing could increase the availability of essential medications and medical devices for the U.S. population.
- Consumers of pharmaceuticals and medical devices in the U.S. might experience changes in pricing and availability, impacting their access to these products.
Reasoning
- The policy aims to identify and overcome barriers in domestic manufacturing of pharmaceuticals which could have diverse impacts.
- Given the budget, the impact may vary among different stakeholders such as pharmaceutical companies, healthcare providers, and consumers.
- Employee perspectives might vary based on the proximity and relevance of the manufacturing initiatives to their work.
- Consumers might not see immediate changes in prices or availability due to the time it takes for manufacturing adjustments.
- A broad range of the population could indirectly benefit through more stable supply chains and potentially lower costs long-term.
Simulated Interviews
Pharmaceutical Sales Representative (New Jersey)
Age: 35 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- This policy could help us in the long-term to reduce reliance on imports for critical components.
- There might be uncertainties in the short term as the industry adjusts.
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 | 8 | 7 |
| Year 20 | 8 | 7 |
Healthcare Policy Analyst (California)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This could provide significant data to help policymakers enhance self-reliance in healthcare essentials.
- The $5 million budget is a limiting factor, but it's a start.
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 | 8 | 7 |
Small Business Owner in Medical Supply (Texas)
Age: 43 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- A clear understanding of manufacturing barriers is much needed.
- If implemented well, could stabilize supplies and reduce costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Chronic Illness Patient (New York)
Age: 55 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- Reducing dependency on imports could lower my medication costs eventually.
- I'm worried about initial disruptions, though.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 4 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Pharmacist (Ohio)
Age: 39 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- If we can produce more domestically, it may lead to more consistent supply and pricing.
- Implementation will need careful monitoring.
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 | 8 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Retired (Florida)
Age: 62 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 15/20
Statement of Opinion:
- I hope this leads to lower prescription costs.
- The changes might be slow, but hopefully worth it.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 6 |
Factory Worker (Michigan)
Age: 47 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- Enhancing local production could mean more job security for people like me.
- The assessment and strategy phases might take time.
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 |
College Student (Illinois)
Age: 25 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- This initiative could greatly benefit public health in the long run.
- It's a great learning opportunity for students like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Health Insurance Consultant (Georgia)
Age: 51 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- Understanding manufacturing barriers could lead to more predictable insurance markets.
- I'm concerned about the transition period costs.
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 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Biomedical Engineer (Georgia)
Age: 33 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm excited to see advancements in domestic production.
- This could speed up R&D in drug manufacturing technologies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $10000000)
Year 2: $0 (Low: $0, High: $0)
Year 3: $0 (Low: $0, High: $0)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The actual impact of FDA's implementation of strategies is uncertain and could vary widely.
- Cost estimates account for immediate administrative costs but may not capture long-term economic shifts.
- Potential savings and impacts on GDP depend on the FDA's recommendations being effectively implemented.