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. Smith, Tina [D-MN]
Target Audience
Population: Individuals involved in or participating in clinical trials globally
Estimated Size: 1000000
- Researchers conducting clinical trials will have reduced costs, allowing them to conduct studies more feasibly.
- Participants in clinical trials may benefit indirectly as more trials could be conducted due to cost savings in acquiring drugs.
- Pharmaceutical companies may be impacted due to the requirement to sell drugs at discounted prices for approved research purposes.
- The healthcare industry, including healthcare providers and institutions involved in clinical research, will be indirectly impacted as they might see an increase in the number of trials and potentially quicker introduction of innovations in treatment.
- Regulatory bodies like the Food and Drug Administration will have an increased role in approving applications for discounted drugs for trials.
Reasoning
- Our simulation includes a diverse group of individuals who are either directly or indirectly affected by the Discounted Drugs for Clinical Trials Act.
- We have included researchers and participants in clinical trials, as they are the most directly impacted by this policy.
- Pharmaceutical companies are represented in our sample to account for the industry's perspective on the requirement to sell drugs at discounted rates.
- Medical professionals involved in clinical research benefit indirectly as this policy could lead to more trials and innovations.
- We ensure to cover individuals not faced with any impact from this policy to maintain perspective on its limited scope in affecting the general public.
- We account for a mix of positive, neutral, and skeptical views towards this policy to reflect realistic public sentiment.
Simulated Interviews
Clinical Researcher (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- This policy is a game-changer for our research budget.
- We can now conduct additional trials leading to possibly groundbreaking findings.
- It allows us more leeway to explore innovative treatment methods with less financial burden.
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 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 5 |
Pharmaceutical Sales Representative (San Francisco, CA)
Age: 30 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I'm concerned about the revenue impact due to discounted sales.
- The policy seems beneficial for research but challenging for sales projections.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 4 | 6 |
| Year 3 | 4 | 6 |
| Year 5 | 5 | 6 |
| Year 10 | 5 | 6 |
| Year 20 | 6 | 6 |
Clinical Trial Participant (Dallas, TX)
Age: 32 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- If this policy means more trials, it increases my chances of receiving cutting-edge treatments.
- It could lead to better management of my condition.
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 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
FDA Regulatory Official (Seattle, WA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 5/20
Statement of Opinion:
- This will mean more work for our team at the FDA.
- However, it ensures that we are actively facilitating important medical research.
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 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Bioethicist (New York, NY)
Age: 40 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- While ethically complex, the policy supports scientific advancement.
- We must ensure that access to discounted drugs doesn’t compromise patient safety.
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 |
Clinical Research Assistant (Chicago, IL)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- I see the direct impact this policy will have on our capacity to recruit and retain participants for trials.
- Reduced drug costs can mean more comprehensive trials which could be beneficial for participants.
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 |
Hospital Administrator (Birmingham, AL)
Age: 60 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- This policy could lead to more trials being conducted at our facility.
- Less financial strain for researchers could foster better partnerships with hospitals.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Graduate Student in Biomedical Research (Phoenix, AZ)
Age: 25 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- This policy gives me hope that more of my research might reach clinical trial phases.
- Access to discounted drugs could remove a significant barrier to trial feasibility.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Public Health Analyst (Raleigh, NC)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- The policy presents an interesting economic challenge for drug pricing.
- It’s potential in enabling more trials is notable but must be balanced with economic implications.
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 | 6 |
Retired Pharmacist (Orlando, FL)
Age: 70 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- This brings back memories of discussing drug accessibility issues.
- It’s a good move for facilitating affordable research but must be monitored for proper implementation.
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 |
Cost Estimates
Year 1: $10000000 (Low: $8000000, High: $12000000)
Year 2: $12000000 (Low: $10000000, High: $14000000)
Year 3: $14000000 (Low: $12000000, High: $16000000)
Year 5: $18000000 (Low: $16000000, High: $20000000)
Year 10: $25000000 (Low: $23000000, High: $27000000)
Year 100: $50000000 (Low: $45000000, High: $55000000)
Key Considerations
- The cost to pharmaceutical companies of providing discounted drugs, which may affect their willingness to participate or renegotiate terms.
- Potential for litigation increases the burden on legal systems.
- The role of the FDA and possible increased workload that might require additional staffing or resources.
- Impact on drug pricing strategy and market dynamics for pharmaceutical companies.