Bill Overview
Title: Discounted Drugs for Clinical Trials Act
Description: This bill allows researchers to obtain certain high-cost drugs and biologics at discounted prices from manufacturers. Researchers must apply to the Food and Drug Administration for approval; manufacturers must sell the approved quantity of drugs to researchers at the discounted price and are subject to civil actions from researchers for noncompliance.
Sponsors: Rep. Maloney, Carolyn B. [D-NY-12]
Target Audience
Population: People involved in clinical trials
Estimated Size: 300000
- The bill primarily targets researchers involved in clinical trials. These researchers will benefit from reduced costs for obtaining high-cost drugs and biologics needed for their studies.
- Patients participating in clinical trials may indirectly benefit, as lowered costs for drugs could potentially lead to larger or more frequent studies, giving patients more opportunities to participate in trials that may be their best treatment option.
- Pharmaceutical companies are also impacted as they are required to comply with this law by providing discounted drugs for approved clinical trials.
- Given the global nature of medical research, researchers from various countries may be involved in these clinical trials, expanding the target population globally.
Reasoning
- The policy mainly targets researchers and participants in clinical trials. It's crucial to understand the perspectives from both sides, as well as pharmaceutical companies that are required to provide discounted drugs.
- Researchers: They directly benefit from cost savings, which could allow for larger-scale studies or reinvestment into additional trials. Their well-being scores are likely to improve as their research goals become more achievable under budget constraints.
- Participants: Individuals participating in trials can potentially benefit, as more opportunities for trials become available, possibly for rare diseases or conditions lacking existing treatments.
- Pharmaceutical companies: While they face the financial burden of offering discounts, they could also benefit from the positive public perception and potential increase in drug usage in the long run.
- General Population: Some may not feel an immediate impact unless they are participating in or are invested in the results of these trials.
Simulated Interviews
Medical Researcher (Boston, MA)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- The policy will enable us to expand our trials and include more patients.
- Lower drug costs mean we can test more compounds, accelerating our research outcomes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Pharmaceutical company executive (San Francisco, CA)
Age: 56 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- It poses financial challenges but could improve the market reach of our products in the long run.
- We are wary of potential compliance costs impacting our bottom line.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Clinical trial participant (Chicago, IL)
Age: 29 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- It's a lifeline for patients like me needing access to cutting-edge therapies.
- Lower costs might lead to more trials for my condition, offering hope.
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 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Clinical trials manager (Houston, TX)
Age: 43 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- Budget constraints make it challenging to run effective trials; this will help.
- More accessible drugs mean better trials and more data.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 6 |
Senior citizen, Medicare recipient (Raleigh, NC)
Age: 62 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 10/20
Statement of Opinion:
- This could expand opportunities for seniors to access new treatments.
- More trials might mean improved treatments available sooner.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Bioethicist (New York, NY)
Age: 52 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This makes advanced therapies more democratically available.
- However, there needs to be oversight to ensure ethical distribution.
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 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Pharmacist (Philadelphia, PA)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 8/20
Statement of Opinion:
- Lower costs may simplify procurement and access to trial medications.
- It may require adjustments in how we manage drug inventories.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Medical university researcher (Dallas, TX)
Age: 34 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- Access to discounted drugs is crucial for our budget-constrained studies.
- It allows for comprehensive exploration of new drug efficiencies.
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 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Data analyst in clinical research (Seattle, WA)
Age: 27 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 7/20
Statement of Opinion:
- More trials mean more data to analyze, which is my core work responsibility.
- It enhances our understanding and creates career growth opportunities.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Patient advocate (Phoenix, AZ)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy can give hope to patients with rare diseases by increasing trial availability.
- It's a positive step for patient empowerment and access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 5 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $22000000 (Low: $17000000, High: $27000000)
Year 3: $23000000 (Low: $18000000, High: $28000000)
Year 5: $25000000 (Low: $19000000, High: $30000000)
Year 10: $28000000 (Low: $21000000, High: $35000000)
Year 100: $40000000 (Low: $30000000, High: $50000000)
Key Considerations
- The extent to which pharmaceutical companies comply with the discounted pricing policy and how they adjust their pricing strategies for other drugs to offset losses.
- The potential administrative burden and associated costs on the FDA in overseeing the program.
- The policy's long-term impact on pharmaceutical innovation and the willingness of companies to invest in new drug development.