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: Rep. Maloney, Carolyn B. [D-NY-12]
Target Audience
Population: People who use pharmaceutical drugs or biologics
Estimated Size: 220000000
- Transparency in pharmaceutical research could lead to increased scrutiny and potentially affect the pricing strategies of pharmaceutical companies.
- Citizens, particularly patients, could access information on drug research costs, which might impact their perceptions of drug pricing fairness.
- Policy makers and regulatory bodies will have more data to assess the pharmaceutical industry, potentially leading to tighter regulations.
- Healthcare providers might use cost data to make more informed decisions regarding drug prescriptions.
- The pharmaceutical industry workforce may see changes as companies adjust to increased transparency demands.
Reasoning
- The policy primarily impacts those engaged with the pharmaceutical industry or dependent on pharmaceutical products, which is a substantial portion of the population (220 million Americans).
- The transparency may not directly reduce costs for individuals but could lead to industry-wide changes like cost management, affecting overall drug pricing potentially in the long term.
- Our simulation covers various stakeholder perspectives, including patients, healthcare providers, industry workers, and policymakers.
- The $25 million budget in year one is focused on setting up systems for data collection and dissemination, affecting those involved in trial cost management and transparency efforts.
- Over 10 years, the policy may indirectly contribute to more informed decision-making among healthcare providers and patients, leading to possible improvements in trust and well-being.
Simulated Interviews
Pharmaceutical researcher (Nashville, TN)
Age: 34 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I'm concerned about the additional workload this policy might generate publicizing detailed trial cost data.
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 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Patient Advocacy Group Leader (New York, NY)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This transparency will empower patients to engage in discussions about drug pricing fairness.
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 | 8 | 6 |
Drug Pricing Analyst (San Francisco, CA)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- The policy will lead to a more informed investment environment but might present short-term volatility.
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 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Primary Care Physician (Chicago, IL)
Age: 53 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 8/20
Statement of Opinion:
- Access to detailed cost data could help me prescribe more cost-effectively for my patients.
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 | 8 | 7 |
Pharmaceutical Company Executive (Houston, TX)
Age: 39 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Transparency might pressure us to alter our R&D strategy but offers a chance to highlight our efficient practices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Grad Student in Public Health (Minneapolis, MN)
Age: 26 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This law is a positive step towards a more transparent healthcare system.
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 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 9 | 6 |
Retired (Phoenix, AZ)
Age: 67 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 12/20
Statement of Opinion:
- I would like to see clearer pricing strategies that align with actual research costs.
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 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Pharmaceutical Sales Representative (Los Angeles, CA)
Age: 42 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- This could be challenging for sales but gives an opportunity to focus on genuine value.
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 |
Factory Worker (Detroit, MI)
Age: 50 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 15/20
Statement of Opinion:
- I hope this leads to cheaper drug prices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 7 | 4 |
Regulatory Affairs Specialist (Miami, FL)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- Transparency aligns well with regulatory goals, though it requires more oversight.
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 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $25000000 (Low: $20000000, High: $40000000)
Year 2: $20000000 (Low: $18000000, High: $35000000)
Year 3: $15000000 (Low: $12000000, High: $30000000)
Year 5: $15000000 (Low: $10000000, High: $30000000)
Year 10: $8000000 (Low: $5000000, High: $25000000)
Year 100: $3000000 (Low: $1000000, High: $15000000)
Key Considerations
- The challenge of ensuring data privacy while making trial data public.
- Potential resistance from pharmaceutical companies due to competition concerns.
- The effect on pharmaceutical innovation if research costs become heavily scrutinized.
- Dependence on pharmaceutical companies' accurate reporting of costs.
- Technological and logistical challenges in setting up and maintaining the national repository.