Bill Overview
Title: Formula Shortage Reporting Act of 2022
Description: This bill requires manufacturers of infant formula to notify the Food and Drug Administration (FDA) at least 72 hours in advance of a manufacturing interruption or product discontinuance that is expected to meaningfully disrupt the product's supply. The FDA must post such information on its website and notify health care providers.
Sponsors: Rep. Johnson, Dusty [R-SD-At Large]
Target Audience
Population: Infants relying on infant formula
Estimated Size: 4800000
- Infant formula is crucial for infants who are not breastfed, and any disruption in its supply can critically impact their health and nutrition.
- Manufacturers are required to notify the FDA, meaning the bill primarily impacts companies producing infant formula to comply with new reporting requirements.
- Healthcare providers will use this information to advise parents and guardians on the availability of infant formula products.
- Approximately 20% of infants in the United States rely on formula exclusively, and up to 50% may use it as a supplement, indicating a large portion of infants may be impacted.
- Any parent or guardian using infant formula, regardless of location, will be interested in potential shortages that could affect their ability to feed their child.
Reasoning
- The Formula Shortage Reporting Act of 2022 primarily impacts families with infants who rely on formula as they are directly affected by potential supply disruptions.
- The policy enables healthcare providers to better advise parents and caregivers by promptly informing them about possible shortages, thus potentially minimizing stress and anxiety related to feeding their infants.
- The act may also indirectly impact some family support services and caregivers who work with affected families, potentially leading to better planning and resource distribution.
- It is unlikely to impact individuals without children or those whose children are beyond the infant stage. Hence, their wellbeing scores will remain largely unchanged regardless of policy implementation.
Simulated Interviews
Financial Analyst (New York City, NY)
Age: 30 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 2.0 years
Commonness: 15/20
Statement of Opinion:
- I constantly worry about formula availability, especially with past shortages.
- Knowing ahead of time about any disruptions would help me plan better and decrease daily stress.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 3 |
Software Developer (Los Angeles, CA)
Age: 34 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- With twins, tracking formula availability is even more critical.
- Advance notification will allow better handling of feeding needs and reduce worry.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 5 | 3 |
| Year 20 | 4 | 3 |
Pediatric Nurse (Chicago, IL)
Age: 40 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- As a healthcare professional, having real-time updates on formula supply is critical to support concerned families.
- Being ahead of shortages helps us better manage prescription choices and parental guidance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Freelance Writer (Austin, TX)
Age: 25 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 20/20
Statement of Opinion:
- I don't have children, so formula shortages don't directly impact me.
- I see this bill as a positive measure, given past shortages and the stress they caused to the affected families I know.
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 | 8 | 8 |
| Year 20 | 8 | 8 |
Stay-at-home Mom (Miami, FL)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 13/20
Statement of Opinion:
- The stress of not knowing when or if there'll be a shortage can be overwhelming.
- This legislation could alleviate some of that stress by allowing me to plan in advance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 7 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 3 |
Infant Formula Manufacturer Executive (Indianapolis, IN)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy requires flexible adjustment in our production and notification processes.
- It pushes for better coordination internally and externally, yet it provides foresight to mitigate potential issues on the consumer side.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 6 | 3 |
Social Worker (Phoenix, AZ)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Notifications can help prevent crises among the most vulnerable families we work with.
- Information is power, and this policy delivers the essential foresight that these families need.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 4 |
Primary Care Physician (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 7/20
Statement of Opinion:
- The ability to inform patients about formula supply can reduce parental anxiety.
- It's a strategic move in patient care where information leads to proactive decision-making.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Grocery Store Manager (Atlanta, GA)
Age: 42 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 1.0 years
Commonness: 8/20
Statement of Opinion:
- Knowing about formula shortages allows for better stocking and communication with customers.
- This relies heavily on the timeliness and accuracy of manufacturers' reporting.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Retail Banking Specialist (Houston, TX)
Age: 33 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 1.0 years
Commonness: 12/20
Statement of Opinion:
- During our time using formula, a policy like this would have been very beneficial.
- It's reassuring to see measures to prevent such critical shortages for new parents now.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Cost Estimates
Year 1: $3000000 (Low: $2000000, High: $5000000)
Year 2: $3000000 (Low: $2000000, High: $5000000)
Year 3: $3000000 (Low: $2000000, High: $5000000)
Year 5: $3000000 (Low: $2000000, High: $5000000)
Year 10: $3000000 (Low: $2000000, High: $5000000)
Year 100: $3000000 (Low: $2000000, High: $5000000)
Key Considerations
- Compliance by manufacturers is crucial to the policy's success, requiring clear guidelines and enforcement mechanisms.
- The effectiveness of the FDA's communication strategy will determine the level of preparedness among healthcare providers and parents.
- Balancing the administrative burden against the potential benefits of improved supply chain transparency is essential.