Bill Overview
Title: Pharmaceutical Research Transparency Act of 2022
Description: This bill requires the disclosure of costs associated with clinical trials and pharmaceutical research and development. Specifically, the National Institutes of Health must create a publicly available repository of cost data from certain clinical trials that test the efficacy of drugs, biological products, and devices in human subjects. For each applicable trial, the registry must, among other information, include the total and per patient cost of the trial, as well as costs for personnel, health care services, and other categories of expenditures. Information must be added to the registry within one year of the trial's completion. The bill also requires drug manufacturers to include their research and development expenditures for drugs and biological products in annual disclosures made to the Securities and Exchange Commission.
Sponsors: Sen. Stabenow, Debbie [D-MI]
Target Audience
Population: People involved or interested in clinical trials and pharmaceutical research
Estimated Size: 15000000
- The bill directly affects pharmaceutical companies, as they must disclose clinical trial costs and R&D expenditures.
- Clinical trial sites, which could include hospitals and research facilities, will also be impacted since their costs and data are part of the required disclosures.
- Researchers involved in clinical trials will indirectly be affected due to transparency in funding and costs.
- Patients participating in clinical trials might see changes in how trials are managed due to increased cost transparency.
- Medical professionals and healthcare administrators involved in or consulted for clinical trials will be affected by changes in reporting requirements.
- Consumers of pharmaceuticals, although indirectly, can benefit from the potential lowering of drug costs due to transparency.
Reasoning
- The policy primarily impacts pharmaceutical companies due to new reporting requirements, leading to potential operational cost increases initially.
- Clinical trial sites will need to be more diligent in tracking and reporting costs, which could increase administrative workload.
- Researchers might have more access to data, which can enhance decision-making regarding trial participation and funding.
- Patients in trials might indirectly benefit if increased transparency leads to lower drug prices or more efficient trials.
- Medical professionals could experience a shift in trial dynamics as reporting requirements are enforced.
- Consumers might see long-term benefits through potential drug pricing impacts, albeit indirectly.
- The policy's budget and reach are limited, hence direct impact is mainly on pharmaceutical companies and associated research entities.
Simulated Interviews
Pharmaceutical Executive (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- The new transparency requirements might increase our operational costs due to the additional administrative burden.
- We hope that this transparency could enhance the industry’s reputation and potentially prevent unfair pricing strategies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 7 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Clinical Trial Manager (Boston, MA)
Age: 38 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- These new reporting requirements might initially complicate our budgeting, but could lead to better cost management in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 8 | 7 |
Healthcare Administrator (San Francisco, CA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Accessing the trial cost data could enhance our ability to align budgets and justify new trial initiatives.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Research Scientist (Austin, TX)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- This policy could lead to increased transparency, which might attract more researchers to join clinical trials.
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 | 9 | 8 |
Consumer Advocate (Chicago, IL)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- I hope that this policy leads to more competitive pricing and greater public trust in drug pricing.
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 | 6 |
| Year 20 | 8 | 7 |
Pharma Sales Representative (Los Angeles, CA)
Age: 42 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- This could lead to a tougher sales environment if it causes drug prices to be more scrutinized.
- Transparency could build better relationships with healthcare providers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 7 |
| Year 20 | 8 | 7 |
Pharmaceutical R&D Specialist (Miami, FL)
Age: 36 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- Ensuring accurate cost reporting could improve resource allocation and project management within our teams.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 9 |
Independent Pharmacist (Seattle, WA)
Age: 60 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Transparency in trial and drug development costs may eventually lead to more favorable pricing for consumers.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Clinical Trial Participant (Denver, CO)
Age: 34 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- I’m hopeful that this legislation could improve the quality and management of trials I participate in.
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 | 7 |
| Year 20 | 7 | 8 |
Insurance Analyst (Houston, TX)
Age: 48 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 8/20
Statement of Opinion:
- Transparency might lead to more informed pricing and policy decisions within the insurance sector.
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 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $25000000 (Low: $15000000, High: $35000000)
Year 2: $20000000 (Low: $12000000, High: $28000000)
Year 3: $20000000 (Low: $12000000, High: $28000000)
Year 5: $18000000 (Low: $10000000, High: $26000000)
Year 10: $15000000 (Low: $9000000, High: $21000000)
Year 100: $5000000 (Low: $3000000, High: $7000000)
Key Considerations
- Need for reliable IT infrastructure to support data management and security.
- Potential resistance from pharmaceutical companies regarding data disclosure.
- The challenge of standardizing cost reporting across diverse clinical trials.