Bill Overview
Title: INSPECTIONS Act
Description: This bill modifies provisions relating to the inspection of foreign drug manufacturing facilities, including by incorporating the compliance history of facilities in foreign countries into inspections and requiring periodic assessments of whether additional agreements with foreign agencies are needed. The bill also requires the Government Accountability Office to report on inspections of foreign facilities.
Sponsors: Rep. Griffith, H. Morgan [R-VA-9]
Target Audience
Population: People dependent on pharmaceuticals from foreign sources
Estimated Size: 200000000
- The bill impacts the pharmaceutical manufacturing industry, especially those involved in the production of drugs and excipients.
- Foreign drug manufacturing facilities will be directly affected by the bill's inspection and compliance measures.
- The pharmaceutical supply chain, including raw material producers and suppliers, will be indirectly impacted through enhanced scrutiny and possibly new compliance requirements.
- Patients relying on medications could be impacted indirectly, as the bill aims to ensure safer pharmaceuticals.
- Regulatory agencies involved in international agreements and inspections are also directly affected.
- Public health may improve with potentially higher quality and safer drug supplies.
Reasoning
- The target population heavily relies on medications whose active ingredients are sourced from abroad. Hence, individuals from various walks of life would be indirectly impacted by any policy change affecting drug imports.
- The policy has a broad range due to its targeting of pharmaceutical safety, so it will impact healthcare providers, patients, and also indirectly affect logistics and supply chain operations.
- Not everyone will experience the changes equally – those who actively rely on medications or work in healthcare or pharmaceutical industries will see more pronounced effects.
- The policy has a long-term effect as it relates to public health improvements and medication safety, but immediate impacts may be less perceptible.
- The cost and budget constraints require focusing on significant, impactful inspections without disrupting the market or overlooking smaller but critical facilities.
Simulated Interviews
Pharmacist (New York, NY)
Age: 40 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- I believe that ensuring the safety of the drugs is crucial for patient safety.
- The policy seems to focus on improving the quality of foreign-sourced drugs, which is essential as many drugs come from abroad.
- There could be cost implications if drug supply is impacted during inspections.
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 |
Retired (Chicago, IL)
Age: 65 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 18/20
Statement of Opinion:
- I think it's important that the drugs I take meet safety standards.
- I'm concerned about the potential increase in cost if this policy is not properly managed.
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 | 7 | 6 |
Logistics Manager for Pharmaceuticals (Los Angeles, CA)
Age: 32 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 8.0 years
Commonness: 10/20
Statement of Opinion:
- The policy would help streamline compliance with foreign suppliers.
- Timely inspections and certifications are crucial to prevent bottlenecks in supply.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 10 | 9 |
| Year 20 | 10 | 9 |
General Practitioner (Houston, TX)
Age: 55 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- Ensuring drug safety from foreign sources ensures my patients receive the best care.
- Introducing more checks could increase operational costs.
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 |
Software Developer (San Francisco, CA)
Age: 29 | Gender: other
Wellbeing Before Policy: 9
Duration of Impact: 3.0 years
Commonness: 16/20
Statement of Opinion:
- The policy seems important for those who rely heavily on daily medication.
- I don't anticipate much change in my situation unless shortages occur.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Quality Assurance Manager in Pharmaceuticals (Miami, FL)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- This policy aligns with my role of maintaining quality standards.
- We may need more resources to ensure new compliance standards are met.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 10 | 9 |
| Year 20 | 10 | 9 |
Retired (Phoenix, AZ)
Age: 74 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 13/20
Statement of Opinion:
- The policy could increase confidence in medicine safety.
- However, availability is also a concern if restrictions cause shortages.
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 | 7 | 6 |
| Year 20 | 7 | 6 |
Regulatory Specialist (Seattle, WA)
Age: 45 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 8.0 years
Commonness: 11/20
Statement of Opinion:
- This bill necessitates tighter control which aligns with my compliance activities.
- There is a risk of increased workload and costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 10 | 9 |
| Year 20 | 10 | 9 |
Patient Advocate (Orlando, FL)
Age: 30 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 14/20
Statement of Opinion:
- Policy could improve medication safety but might increase costs for patients.
- Advocacy groups need to be prepared for changes in drug availability.
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 |
Public Health Official (Boston, MA)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- The policy helps reinforce public health safety.
- Monitoring its implementation is crucial to prevent negative supply chain impacts.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 10 | 9 |
| Year 20 | 10 | 9 |
Cost Estimates
Year 1: $60000000 (Low: $50000000, High: $70000000)
Year 2: $62000000 (Low: $51000000, High: $72000000)
Year 3: $64000000 (Low: $52000000, High: $74000000)
Year 5: $68000000 (Low: $55000000, High: $79000000)
Year 10: $72000000 (Low: $58000000, High: $83000000)
Year 100: $90000000 (Low: $72000000, High: $108000000)
Key Considerations
- The cost of hiring and training additional FDA inspectors for foreign facility compliance is a significant factor.
- Developing and maintaining international agreements for inspections might vary in cost depending on geopolitical and diplomatic contexts.
- Ensuring facilities comply with U.S. standards could temporarily disrupt the supply chain, influencing costs and market dynamics.