Bill Overview
Title: Medical Supply Chain Security Act
Description: This bill requires manufacturers of essential medical devices (i.e., those that are life supporting, life-sustaining, or intended for use for a debilitating disease or condition) to notify the Food and Drug Administration (FDA) if the device is discontinued or if there is any meaningful disruption to the device's manufacturing. The bill also authorizes the FDA to expedite review of such a device to mitigate or prevent a shortage. The bill also requires the manufacturer of an essential medical device or drug to report annually to the FDA certain information, such as details about all locations of production and the sourcing of component parts or active pharmaceutical ingredients.
Sponsors: Rep. Gallagher, Mike [R-WI-8]
Target Audience
Population: People dependent on essential medical devices for survival or quality of life
Estimated Size: 30000000
- The bill aims to prevent shortages of life-supporting and life-sustaining medical devices.
- These devices are used by people with serious medical conditions who rely on them for survival or quality of life.
- The global population with serious medical conditions that require such devices could be in the tens of millions.
- Conditions like diabetes, heart disease, respiratory issues, and others often require medical devices.
- The bill's impact is also on aging populations who are more likely to use medical devices.
Reasoning
- The policy primarily affects individuals who rely on essential medical devices for survival or quality of life, such as those with chronic illnesses.
- A significant portion of the impacted population resides among aging individuals who are more susceptible to chronic conditions.
- This target population is a small subset of the overall U.S. population, thereby allowing the policy budget to be focused intensely on the most affected group.
- Considering the manufacturing and supply chain focus, individuals directly reliant on these devices will notice more impacts, while peripheral populations may not experience direct effects.
Simulated Interviews
Retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- I rely on my insulin pump every day, and any supply issues make me anxious.
- If there's a guarantee of no shortages, it would remove a big worry from my life.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 3 |
Engineer (California)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 10/20
Statement of Opinion:
- It's crucial that my pacemaker works without fail. Any disruption would be terrifying.
- The policy seems like a good safety net.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 7 | 4 |
| Year 20 | 7 | 3 |
Teacher (Texas)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- Oxygen is a lifeline for me, any disruption could be life-threatening.
- This policy could ensure I always have what I need.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 8 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 4 |
| Year 10 | 9 | 3 |
| Year 20 | 8 | 2 |
Retired (New York)
Age: 72 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- My medical alert system is key to my safety, especially living alone.
- Knowing it's reliably available will give me peace of mind.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 7 | 3 |
Software Developer (Illinois)
Age: 35 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 10/20
Statement of Opinion:
- Consistent access to my insulin delivery system is critical.
- This policy ensures a steady supply, minimizing disruption fears.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 6 |
| Year 3 | 9 | 6 |
| Year 5 | 9 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 3 |
Veteran (Ohio)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- Access can sometimes be an issue in rural areas.
- The policy might improve supply consistency here.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 3 |
| Year 10 | 7 | 3 |
| Year 20 | 7 | 2 |
Nurse (Colorado)
Age: 28 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 13/20
Statement of Opinion:
- I depend on my glucose monitor, especially for managing my active lifestyle.
- This policy is a great backup to prevent any gaps in device availability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Retired (Arizona)
Age: 83 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 7.0 years
Commonness: 6/20
Statement of Opinion:
- My caregivers rely on technology to keep me safe.
- Ensuring these devices are always available is comforting.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 3 |
| Year 5 | 7 | 3 |
| Year 10 | 6 | 2 |
| Year 20 | 5 | 1 |
Accountant (Michigan)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- My continuous glucose monitor is critical for managing my diabetes, especially with young kids at home.
- Ensuring supply would ease many worries.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 3 |
Legal Advisor (Washington)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 11/20
Statement of Opinion:
- Supply disruptions for my nebulizer might cause serious health risks.
- A policy ensuring continued availability is reassuring.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 4 |
| Year 10 | 7 | 3 |
| Year 20 | 6 | 3 |
Cost Estimates
Year 1: $100000000 (Low: $75000000, High: $125000000)
Year 2: $102000000 (Low: $76500000, High: $127500000)
Year 3: $104040000 (Low: $78000000, High: $130050000)
Year 5: $108243600 (Low: $81180000, High: $135351000)
Year 10: $120610352 (Low: $90454260, High: $150763440)
Year 100: $25937424601 (Low: $19453068450, High: $32421780752)
Key Considerations
- Coordination with manufacturers to ensure compliance without hampering production.
- Balancing the cost of new FDA processes against the benefits of preventing shortages.
- Impact on domestic manufacturing sectors versus those heavily reliant on imports.
- Potential long-term reductions in emergency imports and associated costs during shortages.