Bill Overview
Title: Protecting Infants from Formula Shortages Act of 2022
Description: This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism. A manufacturer of such a food must notify the Food and Drug Administration (FDA) of any circumstance that is likely to lead to a meaningful disruption of the U.S. supply of the food, including a discontinuance or interruption of manufacturing. The manufacturer must submit the notification at least six months prior to the cause of the disruption or, if that is not possible, as soon as practicable. The FDA must provide the Department of Agriculture and appropriate organizations information about the cause of the disruption. The FDA must inform a person (an individual or entity) of their failure to comply with these notification requirements. If the failure continues for a certain time period, the person shall be subject to fines, imprisonment, or both. During a public health emergency, the FDA may impose additional conditions for such notifications and designate additional categories of food that are subject to the notification requirements. The bill also requires each manufacturer of such a food to develop and maintain a redundancy risk management plan that identifies and evaluates risks for each manufacturing establishment for the food.
Sponsors: Rep. Schrier, Kim [D-WA-8]
Target Audience
Population: People dependent on infant formula and medical foods
Estimated Size: 1830000
- Infants dependent on formula are the primary population targeted by this bill as they rely on formula for nutrition.
- Parents and caregivers of these infants are also directly impacted as they are responsible for obtaining and providing the formula.
- Manufacturers of infant formula are the entities affected by compliance regulations and required to notify the FDA about disruptions in supply.
- The bill targets to prevent shortages and ensure a consistent supply of formula, addressing concerns raised by prior formula shortage events.
Reasoning
- The policy aims to prevent formula shortages, directly affecting infants reliant on formula, their parents, and caregivers. Therefore, I simulated a mix of parents/caregivers who vary in awareness and perspective about the policy.
- A segment of the population relies heavily on formula due to medical conditions, including metabolic disorders. This highlights the need for representation from caregivers of children with special nutritional needs.
- Manufacturers and industry employees are directly impacted by compliance and operational changes. Including their perspectives offers insight into industry challenges, costs, and benefits of increased regulation.
- Rural and low-income populations may feel the effects differently due to limited market access and slower relief in emergencies. Their inclusion provides depth to understanding varied impact by geography and socioeconomic status.
- Given budget limitations, the policy's large-scale preventive nature could lead to less tangible immediate effects but noticeable across broader timelines, justifying analysis over various future scenarios.
Simulated Interviews
Stay-at-home parent (Chicago, IL)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 15/20
Statement of Opinion:
- I depend entirely on formula for my baby's nutrition, so any action to ensure it remains available is crucial.
- This policy sounds like a good safety net in case manufacturers run into production issues. I hope it can avoid scares like I heard about happening to others.
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 | 9 | 5 |
| Year 20 | 9 | 5 |
Dairy Farmer (Rural Kentucky)
Age: 42 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- I live in a rural area where access to formula is already fewer and far between.
- If this policy means helping avoid disruptions to the supply, I'm all for it, but it needs to reach people like us who live far out.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 7 | 3 |
Pediatric Nutritionist (New York, NY)
Age: 28 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 12/20
Statement of Opinion:
- Frequent disruptions or even the fear of them create stress for both parents and healthcare professionals.
- This bill should address one of the structural flaws that could prevent family crises and enable better health outcomes for infants.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 7 |
| Year 3 | 9 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 10 | 5 |
| Year 20 | 10 | 5 |
CEO of Infant Formula Company (San Francisco, CA)
Age: 35 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- Although the policy might increase responsibility and scrutiny, it's necessary for maintaining public trust.
- Any failures in managing supply create issues for families and our business reputation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 3 |
Grocery Store Manager (Houston, TX)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- Shortages seem to cause panic buying like we saw at the height of the pandemic.
- This plan might help keep shelves stocked more consistently. Less disruption means happier customers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 8 | 3 |
Nurse (Phoenix, AZ)
Age: 26 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 12/20
Statement of Opinion:
- It was worrisome during the shortage periods when it felt like there might not be enough for my baby.
- This policy might help ease that anxiety by preventing supply disruptions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 9 | 4 |
Public Health Official (Miami, FL)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 14/20
Statement of Opinion:
- Ensuring we're proactive rather than reactive in maintaining formula supplies is key.
- This bill strengthens our ability to mitigate risks and avoid unnecessary public health panic.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 5 |
| Year 20 | 10 | 5 |
Single Parent (Minneapolis, MN)
Age: 33 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 11/20
Statement of Opinion:
- It's terrifying when there are shortages as options and access become limited when you depend on assistance programs.
- This bill might bring more security and predictability. That's a big relief.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 9 | 2 |
Supply Chain Analyst (Boston, MA)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 9/20
Statement of Opinion:
- Managing risk in critical supplies like infant formula is essential to avoid crisis scenarios.
- This policy's requirement for redundancies should be standard practice across industries.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 4 |
Retired (Portland, OR)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 13/20
Statement of Opinion:
- As someone who helps take care of my grandbaby, I remember seeing my daughter stress during formula shortages.
- This policy seems like it could ease those fears, making me feel better about my grandbaby's future needs.
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 | 7 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 4 |
Cost Estimates
Year 1: $30000000 (Low: $25000000, High: $35000000)
Year 2: $25000000 (Low: $20000000, High: $30000000)
Year 3: $25000000 (Low: $20000000, High: $30000000)
Year 5: $25000000 (Low: $20000000, High: $30000000)
Year 10: $25000000 (Low: $20000000, High: $30000000)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Requiring manufacturing establishments to notify the FDA about potential disruptions in production can prevent significant supply shortages.
- The need for redundancy plans might impose additional operational costs on the manufacturers, passing costs onto consumers.
- The timely enforcement of notification and compliance procedures will be crucial to maintaining a stable supply.
- Public health emergency conditions might affect the scalability and cost of the implemented systems.