Bill Overview
Title: Increasing Transparency in Generic Drug Applications Act
Description: This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
Sponsors: Sen. Hassan, Margaret Wood [D-NH]
Target Audience
Population: Users of generic drugs
Estimated Size: 270000000
- Generic drug manufacturers who submit applications to the FDA will be directly affected as the bill pertains to their application process.
- Brand-name drug manufacturers may experience indirect impacts due to potential increases in generic competition.
- Consumers who rely on generic drugs for affordability will be affected through potential changes in drug availability and pricing.
Reasoning
- The Growing Transparency in Generic Drug Applications Act specifically targets drug manufacturers and consumers who rely on those drugs. Therefore, we need to consider both manufacturers—who are small in number but crucial to drug availability—and the larger consumer base.
- A significant budget constraint limits the policy's initial year spending to $8 million and $80 million over ten years, suggesting it is unlikely to cover large-scale implementations that would affect every potential switchable drug consumer immediately.
- The population of U.S. generic drug users is widespread; household dependencies on generics are common due to cost-effectiveness, but brand-to-generic switching won't happen overnight.
- Policy impact is direct for generic drug manufacturers and indirect for consumers.
- Primary affected users are adults, with variety across occupation, age, and regions.
- Wellbeing impact will differ significantly between manufacturers affected by more accessible FDA procedures and consumers who might see gradual improvements in drug pricing or availability.
Simulated Interviews
Generic Drug Manufacturer (New Jersey)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy will help us with faster approvals and potentially get more drugs to market.
- Currently, we lose time rectifying errors we could have easily avoided with more upfront transparency from the FDA.
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 | 7 |
| Year 20 | 8 | 7 |
Pharmacist (California)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- More generic availability could mean better prices and choices for my customers.
- Transparency will likely bring a slight decrease in medication costs over time.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Retired (Florida)
Age: 62 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- If generics become more affordable, it could really help my fixed income situation.
- But I'm skeptical about how quickly anything will change for prices at the consumer level.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Healthcare Policy Analyst (Texas)
Age: 55 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 1/20
Statement of Opinion:
- This is a step forward for manufacturer transparency, could slightly lower drug costs eventually, but won't revolutionize the market overnight.
- We may see some market dynamics shifts if generic drugs become more competitive.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Brand-name Drug Representative (New York)
Age: 40 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- This policy might increase competition slightly, but brand names have their stronghold on market trust.
- I'm concerned about potential revenue impacts on some lesser-known brand-name drugs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 7 | 8 |
| Year 5 | 7 | 8 |
| Year 10 | 7 | 8 |
| Year 20 | 7 | 8 |
Medical Resident (Illinois)
Age: 28 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 4/20
Statement of Opinion:
- Potentially increased access to affordable generics is a positive.
- I hope this transparency translates into actual benefits for patients' out-of-pocket costs.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Retired Veteran (Ohio)
Age: 70 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- The VA does a good job already, but any additional help in medication pricing or availability is a good thing.
- Hope this can streamline and reduce costs within the system.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Government Healthcare Consultant (Washington)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- Increased transparency should reduce the time manufacturers spend on FDA applications.
- It's potentially a big win for healthcare costs if the savings are passed to consumers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Small Business Owner (Georgia)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- More generics could mean increased competition but also more sales if customers can save money.
- Hopeful this policy increases our ability to stock a wider variety of generics.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Primary Care Physician (Michigan)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 4/20
Statement of Opinion:
- Anything that improves medication affordability is beneficial.
- Hope it leads to more competitive generic pricing for my patients.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $8000000 (Low: $5000000, High: $12000000)
Year 2: $8000000 (Low: $5000000, High: $12000000)
Year 3: $8000000 (Low: $5000000, High: $12000000)
Year 5: $8000000 (Low: $5000000, High: $12000000)
Year 10: $8000000 (Low: $5000000, High: $12000000)
Year 100: $8000000 (Low: $5000000, High: $12000000)
Key Considerations
- The feasibility and timelines of implementing these procedural changes within the FDA.
- Estimating the exact volume of requests and additional reviews the FDA will need to handle because of this policy.
- The overall effect on the generic drug market and the pace at which new generics enter the market.