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: Sen. Stabenow, Debbie [D-MI]
Target Audience
Population: People involved in clinical trials (researchers and patients)
Estimated Size: 500000
- Clinical trial researchers often face high costs when procuring drugs for testing, which can hinder the progress of medical research and development. This act aims to alleviate such financial burdens by facilitating access to high-cost drugs at discounted prices.
- The bill primarily affects researchers who are conducting clinical trials, as these individuals and organizations will benefit from reduced costs of procuring necessary drugs.
- The ability to obtain drugs at lower prices may enhance the operational efficiency of clinical trials, potentially accelerating the development of new medical treatments and benefiting patients globally.
- Patients, particularly those with conditions that are currently part of clinical trials, may benefit indirectly through faster and possibly more thorough research outcomes.
Reasoning
- Clinical researchers form a niche group but play a critical role in advancing healthcare. By reducing drug procurement costs, the policy directly impacts their financial burden and could accelerate research timelines, indirectly affecting a broad patient population.
- Given that the main beneficiaries are researchers and potentially their patients, the overall impact on individual wellbeing scores would generally appear significant within this community.
- The target population in the US is estimated at 500,000, suggesting a reasonable level of reach despite the policy's budget constraints.
- The policy's benefits might manifest as improved efficiency and outcomes of clinical trials, but the direct perceptible impact may vary, especially among those not directly involved in conducting or participating in trials.
Simulated Interviews
Clinical Trial Researcher (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- This policy greatly benefits my work on oncology drugs. We can test more drugs without constantly worrying about the budget.
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 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Biotech Entrepreneur (San Francisco, CA)
Age: 35 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- This policy could accelerate our trials, potentially bringing treatments to market faster.
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 | 9 | 7 |
Clinical Trials Manager (Raleigh, NC)
Age: 28 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Financial relief from this policy would allow us to increase the size and scope of our trials.
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 | 7 | 5 |
| Year 20 | 8 | 5 |
Research Coordinator (Chicago, IL)
Age: 62 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 3/20
Statement of Opinion:
- The potential to expand our trials' reach with reduced costs is promising.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Pharmacologist (Ann Arbor, MI)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Access to lower-cost drugs is a critical enabler for our research to progress efficiently.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Principal Investigator (Houston, TX)
Age: 56 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 12.0 years
Commonness: 5/20
Statement of Opinion:
- This act aligns well with our need for cost-effective solutions in drug procurement.
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 | 8 | 5 |
| Year 20 | 8 | 5 |
Clinical Scientist (Seattle, WA)
Age: 42 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 4/20
Statement of Opinion:
- Anything that helps reduce financial hurdles in obtaining new drugs is welcome.
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 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
CEO of a Clinical Research Organization (New York, NY)
Age: 39 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- The policy has the potential to significantly reduce our operational costs.
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 | 6 |
| Year 20 | 9 | 6 |
Professor of Pharmacology (Atlanta, GA)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Our academic work could reach further with such cost reductions.
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 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Clinical Trials Consultant (Miami, FL)
Age: 48 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- This policy provides a needed boost for smaller firms facing steep drug costs.
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 | 7 | 5 |
Cost Estimates
Year 1: $10000000 (Low: $8000000, High: $12000000)
Year 2: $10500000 (Low: $8500000, High: $12500000)
Year 3: $11000000 (Low: $9000000, High: $13000000)
Year 5: $12000000 (Low: $10000000, High: $14000000)
Year 10: $13500000 (Low: $11500000, High: $15500000)
Year 100: $20000000 (Low: $18000000, High: $22000000)
Key Considerations
- The ability to sustain drug discounts without destabilizing drug manufacturer finances.
- Potential regulatory and bureaucratic challenges in implementing and monitoring compliance with the discounted drug policy.
- The indirect benefits to patients through access to new treatments developed more rapidly because of more efficient clinical trials.
- Legal implications and protection for researchers to act against non-compliant manufacturers.