Bill Overview
Title: Increasing Transparency in Generic Drug Applications Act of 2022
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: Rep. Kuster, Ann M. [D-NH-2]
Target Audience
Population: People using or impacted by access to generic drugs
Estimated Size: 200000000
- The bill aims to increase transparency in the process of approval for generic drugs by the FDA, which could impact pharmaceutical companies applying to produce generic drugs as they gain access to important information more quickly.
- Patients who depend on generic drugs due to their affordability would benefit indirectly as increased transparency could lead to quicker market introduction of generics, potentially lowering drug costs.
- Healthcare providers might also benefit as they could have access to a wider array of generic drug options to prescribe.
- The FDA, as an organization, will be impacted as it expands its task to provide feedback on the sameness of generic drugs to brand-name drugs.
Reasoning
- The budget for this policy limits the scope and scale of its implementation, meaning not every application may receive a detailed review. Furthermore, the impact on the healthcare system—and individual wellbeing—may not be immediate as changes in drug prices and availability due to increased transparency in applications take time to filter through.
- The policy is likely to most directly impact pharmaceutical companies involved in the production of generic drugs, who will experience savings in both time and resources by being informed about deficiencies in their applications earlier.
- The secondary impact is on individuals who rely on generic medications and healthcare providers who may see broader choices in drug prescriptions over time. However, the wellbeing of these individuals will likely be affected in a medium to long-term manner as market conditions adapt.
- Most immediate and noticeable effects will be observed among patients who have illnesses that require expensive medication, assuming the availability of cheaper generics reduces their financial burden.
- The FDA will need to allocate part of the budget to improving their processes and resources to accommodate the increased demand for information transparency.
Simulated Interviews
Pharmacist (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Any policy that promotes generic drug availability helps my patients.
- I believe more transparency can reduce the time it takes for generics to reach the market.
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 | 9 | 7 |
| Year 20 | 9 | 7 |
Retired (Los Angeles, CA)
Age: 68 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- I rely on affordable medication to manage my conditions.
- Lower drug costs through faster approval of generics could ease my financial stress.
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 | 5 |
Generic Drug Manufacturer (Miami, FL)
Age: 32 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This act could significantly ease part of our regulatory challenges.
- It could improve time-to-market for our products if implemented effectively.
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 | 7 | 5 |
| Year 20 | 6 | 5 |
Nurse (Austin, TX)
Age: 27 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 7/20
Statement of Opinion:
- I see daily how difficult it is for patients to afford their medication.
- Greater competition from generic drugs could lower prices and help my patients.
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 |
FDA Employee (Chicago, IL)
Age: 54 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This increases our workload but could make approval processes more streamlined.
- We'll need proper resources to ensure detailed feedback on applications.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 5 |
Healthcare Policy Analyst (Detroit, MI)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Providing clarity in drug applications enhances market dynamics.
- While direct benefits may be slow, this is a step towards better healthcare access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Patient Advocacy Outreach Coordinator (Phoenix, AZ)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Patients would benefit from more affordable medication arriving sooner.
- Skeptical about how quickly changes will be implemented.
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 | 7 | 7 |
Chronic Pain Patient (Seattle, WA)
Age: 60 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I've had to sacrifice other expenses to afford my medications.
- Quicker approval of generic drugs could save me a lot financially.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Hospital Administrator (Atlanta, GA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 4/20
Statement of Opinion:
- Efficient generic approval processes could trim our operating costs.
- It might lower the cost to the patient and hospital, a win-win scenario
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Insurance Underwriter (Dallas, TX)
Age: 36 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 5/20
Statement of Opinion:
- This can adjust the formulary to include more affordable generics.
- Transparent drug application processes might reflect positively in insurance premiums.
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 | 6 | 6 |
| Year 20 | 6 | 6 |
Cost Estimates
Year 1: $15000000 (Low: $10000000, High: $20000000)
Year 2: $14500000 (Low: $9500000, High: $19500000)
Year 3: $14000000 (Low: $9000000, High: $19000000)
Year 5: $14000000 (Low: $9000000, High: $19000000)
Year 10: $14000000 (Low: $9000000, High: $19000000)
Year 100: $14000000 (Low: $9000000, High: $19000000)
Key Considerations
- The bill mandates a potentially complex feedback loop between the FDA and generic drug manufacturers which could require a significant increase in administrative workload.
- Potential for accelerated generic drug approvals could indirectly lead to reduced healthcare costs for consumers.
- The FDA's operational processes might require changes to efficiently manage the additional responsibilities.
- Long-term impacts on drug prices and market dynamics in the pharmaceutical industry need to be monitored.
- Consideration of how the FDA's current resources could be strained without appropriate funding.