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, the brand-name drug is subject to an active patent or exclusivity period and a revised label for the brand-name drug is approved within 90 days (rather than 60 days) of the expiration of the patent or exclusivity period.
Sponsors: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Target Audience
Population: People relying on affordable medications
Estimated Size: 200000000
- The bill directly affects patients and consumers who require medication, particularly those who need access to affordable generic versions.
- The bill encourages the introduction of generic drugs to the market more quickly after the expiration of a patent or exclusivity period, resulting in a broader choice of affordable medications.
- The global population reliant on medications, especially those in countries with similar pharmaceutical patent laws to the US, will experience changes in drug availability.
- Manufacturers of generic drugs are indirectly affected as the legislation potentially streamlines their market entry.
- Medical professionals who prescribe medications may find more options in budget-friendly prescriptions for their patients.
Reasoning
- The population impacted by this policy is large, as many Americans rely on prescription medications, and generic options significantly reduce costs, making them more accessible.
- Not everyone in the US will be directly affected because some people might not be reliant on medications or can afford brand-name drugs.
- The policy has a limited budget, meaning not all scenarios can be addressed by this act. Therefore, actual impact may vary by demographic factors such as age, income, and current medication needs.
Simulated Interviews
retired (Florida)
Age: 70 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- I often struggle to afford my medications because they're so expensive.
- Having cheaper options sooner would help me manage my health better.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
nurse (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- I see the struggle patients have accessing affordable medications.
- More accessible generics would drastically improve outcomes for my patients and my own financial burden.
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 | 8 | 6 |
| Year 20 | 7 | 6 |
software engineer (New York)
Age: 28 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 10/20
Statement of Opinion:
- I am not affected much by drug costs because of my insurance.
- Still, I think it could benefit others who aren't as lucky in having good coverage.
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 |
primary school teacher (Texas)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 13/20
Statement of Opinion:
- As a teacher, my salary is not high, and saving money on medication would help a lot.
- I am all for policies that can make medication more affordable.
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 | 8 | 7 |
| Year 20 | 7 | 7 |
small business owner (Ohio)
Age: 52 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- My business expenses and healthcare costs are rising, making it tough to manage.
- Lower drug prices could allow me to redirect funds to my business and employees.
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 | 6 | 6 |
| Year 20 | 6 | 6 |
construction worker (Illinois)
Age: 62 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- I have to pay out-of-pocket for meds sometimes, and it's really hard.
- The policy seems like it could offer some relief from high costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
graduate student (Oregon)
Age: 25 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- Affording medication can be tough with my part-time income.
- A faster route for generics could lessen my financial stress.
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 | 7 |
| Year 20 | 7 | 7 |
pharmacist (New Jersey)
Age: 39 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- I see the impact of drug prices on my clients daily.
- This policy could significantly help those without insurance coverage.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
farmer (Montana)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Healthcare takes a big part of our family budget.
- Cheaper medications can mean more money for other important farm investments.
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 | 6 | 6 |
| Year 20 | 6 | 6 |
freelance journalist (Washington D.C.)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 7.0 years
Commonness: 6/20
Statement of Opinion:
- Freelancing leaves me at a disadvantage without employer coverage.
- Making generics more readily available would ease my out-of-pocket expenses.
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 | 7 |
| Year 20 | 7 | 7 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $21000000 (Low: $16000000, High: $26000000)
Year 3: $22000000 (Low: $17000000, High: $27000000)
Year 5: $24000000 (Low: $19000000, High: $29000000)
Year 10: $28000000 (Low: $23000000, High: $33000000)
Year 100: $40000000 (Low: $35000000, High: $45000000)
Key Considerations
- The bill impacts patent holders, potentially accelerating the market entry of competitors.
- The collaboration and effectiveness of the FDA's workflow with pharmaceutical companies is critical for successful implementation.
- Potential administrative and regulatory adaptation costs should be factored into long-term financial planning.