Bill Overview
Title: Registration of Certain Foreign Establishments Act
Description: This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration. Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
Sponsors: Sen. Peters, Gary C. [D-MI]
Target Audience
Population: Workers at foreign manufacturers of drugs or medical devices exporting to the U.S.
Estimated Size: 100000000
- The bill affects foreign manufacturers of drugs or medical devices for the U.S. market.
- These foreign establishments must now comply with additional registration requirements with the FDA.
- There are countless manufacturers across the globe that export to the U.S., making the exact number difficult to pin down.
- Each manufacturer likely employs a number of workers whose jobs may be affected by these new regulations.
Reasoning
- The policy primarily affects foreign manufacturers who export drugs and devices to the U.S., but changes in availability and cost could trickle down to affect U.S. citizens, especially those who rely on imported drugs or medical devices. Such impacts might take the form of adjustments in healthcare options or availability of medications, affecting their reported wellbeing.
- To illustrate the range of impacts, we've simulated interviews across different roles such as healthcare providers, patients, and those working in regulatory or supply chain sectors. Their reactions help us gauge indirect implications like shifts in medical practice, changes in availability, and public health repercussions.
- Despite the reach of this policy affecting a substantial number of people indirectly, its immediate tangible effects on well-being for some may not be drastic, leading to variations ranging from 'none' to 'medium'. The commonness metric helps assess how typical each scenario is within the U.S. population impacted, ensuring a diverse representation.
Simulated Interviews
Pharmacist (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- This policy seems needed for ensuring drug safety, but I'm concerned about potential delays in receiving medications due to new layers of compliance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Patient (Ohio)
Age: 62 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- If this policy disrupts the supply of my device, I might have to switch to a less effective alternative or face higher costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Healthcare consultant (Texas)
Age: 33 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- This regulation can increase opportunities for me to help clients navigate compliance, though there may be pushbacks.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Medical supply chain manager (New York)
Age: 28 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- New compliance requirements might complicate supply chains initially, but these regulations could enhance quality assurance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
FDA regulatory officer (Washington)
Age: 54 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- This policy strengthens my role in ensuring public safety, though it could stretch resources thin in the short term.
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 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Biochemistry student (Florida)
Age: 19 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 15/20
Statement of Opinion:
- I think it's important for the U.S. to maintain high standards for drug safety, but we need to consider global impacts too.
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 | 9 | 9 |
| Year 20 | 9 | 9 |
Hospital administrator (Illinois)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 8/20
Statement of Opinion:
- This regulation could tighten budgets if imports get pricier, yet it serves to reinforce patient safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
General practitioner (Boston)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 9/20
Statement of Opinion:
- This will hopefully improve patient outcomes by ensuring higher quality drugs; however, it may complicate medication access temporarily.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 9 |
| Year 20 | 9 | 9 |
Import/export business owner (Georgia)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 11/20
Statement of Opinion:
- The regulation may lead to additional paperwork and delays initially, but it potentially opens the market for compliance-ready businesses.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Health policy analyst (Arizona)
Age: 48 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 7/20
Statement of Opinion:
- This policy is a necessary step towards systemic regulatory improvement, but careful oversight will be crucial to minimize patient impacts.
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 | 9 | 9 |
| Year 20 | 9 | 9 |
Cost Estimates
Year 1: $45000000 (Low: $40000000, High: $50000000)
Year 2: $30000000 (Low: $25000000, High: $35000000)
Year 3: $20000000 (Low: $15000000, High: $25000000)
Year 5: $15000000 (Low: $10000000, High: $20000000)
Year 10: $10000000 (Low: $5000000, High: $15000000)
Year 100: $5000000 (Low: $2000000, High: $10000000)
Key Considerations
- Foreign manufacturers are now required to comply with U.S. regulations, potentially increasing their operational costs.
- This could affect drug prices or supply chains due to the additional compliance burden on foreign entities.
- The FDA's role is expanding, requiring additional funding and resources but also improving public health safety.