Bill Overview
Title: More Options for Infants and Parents Act of 2022
Description: This bill requires the Food and Drug Administration (FDA) to (1) act upon any pending applications from domestic manufacturers for new infant formula within 14 days of the bill's enactment, and (2) maintain a list on its website of infant formula products that may be substituted for certain specialized infant formula products that are in shortage. It also authorizes the FDA to waive certain labeling and nutritional requirements in furtherance of other necessary infant formula product substitutions.
Sponsors: Rep. Guthrie, Brett [R-KY-2]
Target Audience
Population: Infants and parents relying on formula for infant feeding
Estimated Size: 15000000
- The bill aims to address shortages and provide more infant formula options.
- The primary group affected would be infants who rely on formula for nutrition.
- Parents of infants, who may face less stress knowing alternative options are available during shortages, would also be impacted.
- Domestic manufacturers of infant formula are directly impacted due to the requirement for rapid application processing.
- Secondary impacts could be on healthcare providers who advise parents about infant nutrition products.
Reasoning
- The bill primarily impacts a moderate yet significant portion of the infant and parent demographic, specifically those relying heavily on formula feeding.
- The impact on domestic manufacturers is heavily tied to FDA processing efficiency and the availability of alternative products during shortage scenarios.
- The policy's efficacy is likely to be reflected in reduced parental anxiety and improved access to nutrition for infants, hence scoring higher in wellbeing over time if successful.
- The coverage of this policy relative to its budget appears sufficient to address key shortages without extending beyond fiscal constraints.
Simulated Interviews
HR Manager (New York, NY)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- It's reassuring to have an official system that will step in during shortages.
- I've experienced stress when formula was scarce.
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 | 9 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Pediatrician (Houston, TX)
Age: 41 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 2/20
Statement of Opinion:
- Better availability of options during shortages will reduce hospital visits.
- It's essential to adjust the policy quickly if shortcomings appear.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Stay-at-home mom (Columbus, OH)
Age: 34 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Knowing there are substitutes takes a lot of the stress out of shopping.
- I wish this policy had been in place before my first child.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 6 |
| Year 2 | 9 | 6 |
| Year 3 | 9 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
CEO of local formula manufacturing company (Chicago, IL)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 1/20
Statement of Opinion:
- Faster FDA response helps us smooth operations and adapt to demand.
- Short-term profit potential, but important in consumer trust.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Health Policy Advocate (Miami, FL)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 1.0 years
Commonness: 2/20
Statement of Opinion:
- Policy is a great step forward but needs scaling to include enforcement.
- Crucial that exemptions don't lower product quality.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
New mother (Los Angeles, CA)
Age: 25 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Awesome that there will be more options available.
- Previously had to drive several hours to find formula.
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 | 8 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 4 |
Pharmacist (Seattle, WA)
Age: 38 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 2/20
Statement of Opinion:
- The relief should be substantial for parents during shortages.
- It'll be nice not having to redirect so many frantic parents.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Freelance Writer (Denver, CO)
Age: 32 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- A sensible policy for preventing future stress for parents.
- Will blog about the new changes to inform other mothers.
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 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Public Health Official (Phoenix, AZ)
Age: 45 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 1.0 years
Commonness: 2/20
Statement of Opinion:
- The expedited FDA actions are good, but implementation will show true effectiveness.
- This is just a starting point for comprehensive infant nutrition support.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 6 |
Data Analyst (San Francisco, CA)
Age: 28 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Expect measurable effects on local availability metrics.
- Hope it brings more consistency to an unpredictable market.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $20000000 (Low: $15000000, High: $25000000)
Year 3: $0 (Low: $0, High: $0)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The existing workload and capacity of the FDA to handle additional responsibilities without affecting other operations.
- Potential pushback or requests for clarity from manufacturers regarding the criteria for waiving labeling requirements.
- The ongoing nature of shortages and how long the FDA is expected to maintain the substitute list.