Bill Overview
Title: Enhanced Access to Affordable Medicines Act of 2022
Description: This bill specifies that the Food and Drug Administration may approve generic drugs with different labels than the brand-name versions if, among other requirements, a revised label for the brand-name drug is approved within 90 days of when the generic is otherwise eligible for approval.
Sponsors: Sen. Romney, Mitt [R-UT]
Target Audience
Population: People relying on prescription medications
Estimated Size: 220000000
- The bill primarily impacts individuals who require prescription medications, as it aims to enhance access to affordable generic drugs.
- Generic drugs typically cost less than brand-name drugs, so the potential cost savings could impact anyone who may require medication, lowering their out-of-pocket expenses.
- As the FDA is a U.S. agency, the primary impact is on U.S. residents, but the approval of generics potentially influences global markets by setting a precedent.
Reasoning
- The overall population affected by the policy is very large, given the widespread use of prescription medications in the U.S. However, the policy's immediate benefit is primarily financial, affecting individuals who frequently purchase medications, especially those on long-term prescriptions.
- The cost savings due to generic drugs may be more significant for individuals whose health conditions require expensive brand-name drugs not yet available in a generic form.
- The policy might have little impact on individuals who rarely need medications or whose conditions are already managed by existing generics.
- The effect on wellbeing will vary across the population, as some people may experience significant financial relief, while others may see little to no change in their situation. Therefore, individuals' scores will reflect diverse impacts.
- Considering the budget limitations, the policy must focus on those with the highest out-of-pocket costs or those needing the most expensive medications.
- In planning, acknowledging the diversity in drug needs across different demographics will help in identifying key groups that will benefit most and justify funding allocation.
Simulated Interviews
retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 15/20
Statement of Opinion:
- I really hope this policy reduces the costs of my medication. It gets expensive, especially being on a fixed income.
- Switching to generics has helped before, so having more options will surely ease my financial burden.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 4 |
software engineer (California)
Age: 45 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- I seldom need prescription meds, so I doubt this will impact me significantly.
- It will be nice to know generics are cheaper if I ever need them more regularly.
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 |
marketing (New York)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 20/20
Statement of Opinion:
- Since I take medications regularly, having more affordable options would be beneficial.
- It might not make a big difference in my life, but small savings add up over time.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
small business owner (Texas)
Age: 55 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- The cost of my diabetes medications is steep; having cheaper generics faster would ease a lot of my stress.
- Anything that drives prices down is a welcome change in my situation.
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 | 9 | 6 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
mechanic (Ohio)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Most of my medications are covered by veteran benefits anyway, so this policy might not affect me much.
- Still, having cheaper generics could lower the overall healthcare costs, which could be beneficial in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
teacher (Illinois)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- Getting a generic version of my antidepressants would help me save money.
- It's a small measure, but all cost reductions matter to me as a teacher.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
construction worker (Pennsylvania)
Age: 40 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 14/20
Statement of Opinion:
- With a family of four, healthcare costs are a big part of our budget.
- Generics usually mean lower prices, which could add up to real savings for us.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
freelance writer (Washington)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- Affordable generics can save me money I spend on statins.
- Even minor savings can make a difference on my independent income.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
retired (Arizona)
Age: 75 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 11/20
Statement of Opinion:
- My heart medications are quite expensive, so this could have a big impact on my wellbeing.
- I'm hopeful this means financial relief for lots of folks like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 7 | 3 |
stay-at-home parent (Georgia)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 7/20
Statement of Opinion:
- With young kids, any reduction in medication costs is helpful.
- Generics reduce the burden on our pocket, which adds security for our family.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Cost Estimates
Year 1: $10000000 (Low: $5000000, High: $15000000)
Year 2: $10000000 (Low: $5000000, High: $15000000)
Year 3: $10000000 (Low: $5000000, High: $15000000)
Year 5: $10000000 (Low: $5000000, High: $15000000)
Year 10: $10000000 (Low: $5000000, High: $15000000)
Year 100: $10000000 (Low: $5000000, High: $15000000)
Key Considerations
- As the FDA will be involved in additional reviews, their resource allocation and staffing may influence cost efficiency.
- The time to market for generics could be improved, significantly impacting drug pricing dynamics in the near term.
- The main goal is affordability and accessibility; thus, political and public feedback could shape long-term implementations.