Bill Overview
Title: FDA Ethics Act of 2022
Description: This bill establishes several requirements for entities that contract with the Food and Drug Administration (FDA) relating to conflicts of interest, including requiring contractors to disclose conflicts of interest on an ongoing basis and prohibiting the FDA from hiring consultants who simultaneously provide services to drug manufacturers or other entities that are regulated by the FDA.
Sponsors: Rep. Kuster, Ann M. [D-NH-2]
Target Audience
Population: Individuals consuming FDA-regulated products worldwide
Estimated Size: 334000000
- The FDA regulates food and drugs in the United States, impacting the entire U.S. population.
- Ensuring ethics and conflict of interest in FDA operations maintains trust in drug approvals and safety measures, affecting all who consume food and drugs.
- Entities that contract with the FDA, including individuals, businesses, and drug manufacturers, will be directly impacted.
- Consumer safety and trust might indirectly impact their well-being as decisions will be more transparent and less conflicted.
Reasoning
- The policy primarily targets contractors, FDA employees, and consultants, aiming to enhance transparency to protect consumer interests.
- The general U.S. population might not directly feel the impact, but their trust in FDA-approved products could increase, influencing their perceived well-being.
- Budget and program size constraints mean direct effects are limited to inside players of the FDA and its contracts, but the wider perception of safety affects all consumers indirectly.
- Cantril Wellbeing scores provide a subjective measurement of quality of life before and after the enactment of the policy.
Simulated Interviews
FDA Consultant (Bethesda, Maryland)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- The Ethics Act will create a conflict of interest for me, forcing a choice between consulting roles.
- I may need to pivot to working directly for the FDA or one of the contracting companies, losing one income stream.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 8 | 7 |
Pharmaceutical Executive (Boston, Massachusetts)
Age: 38 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The policy could complicate our interactions with the FDA and increase scrutiny.
- In the long term, it might restore consumer trust, beneficial for our industry.
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 |
FDA Employee (Raleigh, North Carolina)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy strengthens our role and upholds the FDA's integrity.
- With transparency, public trust should increase but it burdens oversight processes.
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 | 9 | 6 |
Biotechnologist (San Francisco, California)
Age: 29 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The policy provides clarity for startups like mine looking to collaborate ethically.
- It may slow certain processes due to additional checks but ensures fairness.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Retired (Austin, Texas)
Age: 60 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- This kind of policy bolsters my trust in the medications I take.
- The immediate effects are negligible, but knowing there's less conflict gives peace of mind.
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 | 7 | 7 |
| Year 20 | 6 | 6 |
Graduate Student (Chicago, Illinois)
Age: 25 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- The Ethics Act serves as an interesting case study for my research.
- While I don't feel direct effects, understanding such policies will benefit my career.
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 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Regulatory Affairs Specialist (Seattle, Washington)
Age: 33 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Compliance with this policy is a part of my day-to-day job.
- It makes my role more demanding but improves long-term job satisfaction by contributing to ethical practices.
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 | 9 | 8 |
Chef (Denver, Colorado)
Age: 41 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- The ethics policy is abstractly reassuring, assuring ingredients are vetted safely.
- Indirectly affects my work, but overall it's a positive measure for consumer trust.
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 | 7 | 7 |
| Year 20 | 7 | 7 |
Consumer Advocate (Los Angeles, California)
Age: 48 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This policy addresses critical transparency concerns.
- Overall satisfaction improves knowing conflicts of interest are minimized.
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 | 9 | 8 |
| Year 20 | 9 | 8 |
Retired Pharmacist (Miami, Florida)
Age: 72 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- The Ethics Act reinforces the transparency that was sometimes lacking during my career.
- It's important for the younger generation and upholds safety and integrity.
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: $15000000 (Low: $10000000, High: $20000000)
Year 2: $15000000 (Low: $10000000, High: $20000000)
Year 3: $15000000 (Low: $10000000, High: $20000000)
Year 5: $15000000 (Low: $10000000, High: $20000000)
Year 10: $15000000 (Low: $10000000, High: $20000000)
Year 100: $15000000 (Low: $10000000, High: $20000000)
Key Considerations
- The FDA Ethics Act aims to improve transparency and reduce conflicts of interest at the FDA.
- Administrative costs largely drive the policy's implementation, with a focus on ongoing compliance and monitoring mechanisms.
- There may be indirect economic benefits from increased transparency, benefiting public trust in FDA-approved products.