Bill Overview
Title: Data Transparency and Drug Safety Act of 2022
Description: This bill makes it a prohibited act under the Federal Food, Drug, and Cosmetic Act to destroy or falsify certain records pertaining to drugs regulated by the Food and Drug Administration (FDA). Specifically, the bill prohibits falsifying, destroying, omitting. or removing records or information that (1) must be produced during the development or manufacture of a drug, (2) must be produced in an application for FDA approval for a drug or maintained after a drug is approved, or (3) is subject to FDA inspection. A person (entity or individual) that violates this provision shall be subject to civil monetary penalties. The bill also provides for additional monetary penalties in instances where the violation is not sufficiently remedied after the responsible person has received written notice from the FDA of the violation.
Sponsors: Rep. Schrier, Kim [D-WA-8]
Target Audience
Population: Global population benefiting from safer drug regulations
Estimated Size: 331000000
- The bill impacts pharmaceutical companies and entities involved in drug manufacturing and development due to new obligations regarding record keeping and the potential for penalties in cases of non-compliance.
- The bill will indirectly affect all consumers of FDA-approved drugs because increased transparency and accountability in drug production are expected to enhance drug safety.
- Researchers accessing drug manufacturing data, healthcare institutions, and policymakers may have better access to accurate data, improving overall drug safety measures.
Reasoning
- The target population includes both producers of pharmaceuticals and consumers as the policy involves both parties. While the direct impact is on FDA-regulated companies, the broad public benefits from increased drug safety and transparent practices.
- Ensuring transparency may save costs related to litigations and health incidents from unsafe drugs, but initially, the financial impact through penalties or compliance expenses on pharmaceutical companies will be evident.
- The budget constraints should also consider the enforcement and administrative costs which encompass audits, investigation, and reporting measures to ensure compliance.
- The policy's long-term goal is to build trust in drug safety, which reduces healthcare costs and potential health crises.
Simulated Interviews
Clinical Trial Manager (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- I think the policy will encourage accountability and improve the data accuracy in clinical trials, which is crucial for safe drug development.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Regulatory Affairs Specialist (New Jersey)
Age: 30 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This adds further regulatory pressures which can be challenging, but overall, it should enhance the reputation and trust in our drugs.
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 |
Healthcare Consultant (Texas)
Age: 50 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- The long-term benefits could outweigh the immediate challenges; hospitals will rely more on transparent reports that ensure drug safety.
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 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Biomedical Researcher (Massachusetts)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy is crucial for the integrity of my work. It means more reliable data and subsequently better health outcomes.
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 | 10 | 7 |
| Year 20 | 10 | 7 |
FDA Inspector (Washington)
Age: 55 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- This will make inspections more efficient and meaningful, ultimately leading to better drug safety measures.
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 |
Physician (Illinois)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 6/20
Statement of Opinion:
- Improved safety and transparency help physicians trust new medications more fully.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Drug safety is paramount in my life. I believe these changes will make my medications safer.
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 |
Pharmacy Student (New York)
Age: 22 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- This policy signifies an important progression in pharmaceutical education and practice, emphasizing ethics in compliance.
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 |
Pharmaceutical Compliance Officer (Georgia)
Age: 39 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Although the increased scrutiny challenges us, it compels our company to uphold superior standards.
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 |
Public Health Advocate (Michigan)
Age: 48 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- The broader implications of this policy lead to stronger consumer protections, which is a fundamental goal of our work.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $45000000 (Low: $35000000, High: $55000000)
Year 2: $45000000 (Low: $35000000, High: $55000000)
Year 3: $45000000 (Low: $35000000, High: $55000000)
Year 5: $45000000 (Low: $35000000, High: $55000000)
Year 10: $45000000 (Low: $35000000, High: $55000000)
Year 100: $45000000 (Low: $35000000, High: $55000000)
Key Considerations
- The balance between enforcement costs and revenues from fines and penalties will significantly impact overall fiscal outcomes.
- The potential for indirect savings in healthcare costs must be weighed against direct enforcement and compliance costs.
- Implementation timelines can affect both short-term and long-term financial estimates and need to be considered.