Bill Overview
Title: To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
Description: This bill requires the Food and Drug Administration to conduct a pilot program to increase the number of unannounced inspections of foreign drug manufacturing facilities and evaluate the differences between inspections of domestic and foreign facilities.
Sponsors: Rep. Hudson, Richard [R-NC-8]
Target Audience
Population: People involved in the manufacturing, regulation, and distribution of foreign drugs
Estimated Size: 1500000
- The bill targets foreign human drug establishments which directly affects those involved in the manufacturing process including employees and managerial staff of these facilities.
- Indirectly, the bill impacts the supply chain that depends on foreign drug manufacturers. This includes distribution companies, pharmacies, healthcare providers, and patients using medications sourced from these facilities.
- It is anticipated that the findings of these inspections could lead to changes in regulatory practices which would impact all drug manufacturing establishments, both foreign and domestic, though primarily foreign ones in the immediate term.
- The global pharmaceutical market is heavily reliant on manufacturing facilities located in countries such as India and China, who are major suppliers of generic drugs worldwide.
Reasoning
- The policy primarily impacts individuals working in and interacting with foreign drug manufacturing facilities. This includes employees overseas, U.S. regulatory staff involved in inspections, and potentially affects pharmacies and healthcare providers through changes in drug availability.
- A significant secondary group includes U.S. consumers who rely on medications manufactured in foreign facilities. Changes in the inspection process may lead to scrutiny which could affect availability, safety, and trust in these medications.
- The policy is constrained by budget limits, meaning the number and scope of inspections need to be strategically planned to maximize impact without overspending.
- Given the indirect nature of this policy's impact on the average U.S. resident, the diversity of opinions and degrees of impact will vary significantly, with more pronounced effects among those directly involved in pharmaceutical manufacturing and regulation.
Simulated Interviews
Pharmacist (Boston, MA)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- I think it's important for there to be more transparency in the drug manufacturing process.
- As a pharmacist, my main concern is ensuring that patients receive safe medications.
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 | 7 | 6 |
| Year 20 | 6 | 5 |
FDA Inspection Officer (Los Angeles, CA)
Age: 34 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The policy might mean more work for us, but it could lead to safer drugs on the market.
- I am concerned about the logistics and whether budget is sufficient for meaningful changes.
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 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Healthcare Provider (Chicago, IL)
Age: 55 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- If this leads to better monitoring, it is beneficial for patient safety.
- I fear the policy might cause drug shortages if facilities are found lacking.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Medical Researcher (New York, NY)
Age: 26 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- Research could benefit from understanding how foreign manufacturing standards affect drug quality.
- Concerned about potential delays in drug availability impacting research timelines.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 6 |
Supply Chain Manager (Houston, TX)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 8/20
Statement of Opinion:
- The policy might create supply chain disruptions depending on inspection outcomes.
- Improving the reliability of foreign manufacturing is beneficial in the long run.
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 | 5 |
| Year 20 | 6 | 5 |
Patient (San Francisco, CA)
Age: 49 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 18/20
Statement of Opinion:
- Safety is critical but am worried about costs and accessibility of medications after inspections.
- Policies must balance between safety and affordability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Journalist (Seattle, WA)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 1.0 years
Commonness: 9/20
Statement of Opinion:
- The transparency aspect is crucial for public trust in pharmaceuticals.
- It's important to approach these inspections without bias to ensure fair reporting.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Retired (Miami, FL)
Age: 63 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 20/20
Statement of Opinion:
- I want reassurance that medications are safe, but not at the cost of availability.
- There's a need for balance between thorough checks and practical outcomes.
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 | 5 | 5 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Drug Manufacturer (Philadelphia, PA)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- The policy is necessary but might lead to cost increases if facilities need retrofitting.
- Long-term improvements could increase trust in drugs, offsetting short-term costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Regulation Specialist (Washington, DC)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 6/20
Statement of Opinion:
- The policy could streamline compliance standards worldwide if executed well.
- It’s essential to ensure that foreign inspections truly reflect domestic standards.
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 | 8 | 7 |
| Year 20 | 8 | 6 |
Cost Estimates
Year 1: $15000000 (Low: $10000000, High: $20000000)
Year 2: $15000000 (Low: $10000000, High: $20000000)
Year 3: $15000000 (Low: $10000000, High: $20000000)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- This is a pilot program and its primary costs involve the administrative and logistical expenses of increased inspections and analyses.
- There is potential for policy changes following the pilot conclusions, which could result in broader impacts not entirely predictable at present.
- Coordination with foreign governments and compliance with their rules and regulations might introduce additional complexities and costs.