Bill Overview
Title: Reducing Animal Testing Act
Description: This bill removes animal studies as a required component of biosimilar applications and instead allows applicants to use other types of studies to assess toxicity.
Sponsors: Sen. Lujan, Ben Ray [D-NM]
Target Audience
Population: People impacted by changes in pharmaceutical testing requirements and ethics
Estimated Size: 250000000
- The bill affects the process of drug testing, specifically biosimilar applications, which is related to pharmaceutical industries.
- People concerned with pharmaceutical ethics, particularly animal testing, will be interested in and affected by this change.
- This includes healthcare professionals who prescribe medications, patients who use these drugs, and drug manufacturers.
- Animal rights activists and organizations will also be impacted by this legislation as it reduces the use of animals in testing.
- Given the global nature of pharmaceutical companies, this legislation could have international implications.
Reasoning
- The policy primarily affects pharmaceutical testing environments and ethical concerns related to animal testing, so impacted individuals may be healthcare professionals, patients using biosimilar drugs, pharmaceutical company executives, and animal rights activists.
- The budget limitation implies that while immediate impact on direct stakeholders can be substantial, broader societal change might be gradual and largely dependent on industry adoption and consumer awareness.
- Given the size of the pharmaceutical industry in the US and the number of potentially affected groups, we should expect varying impacts—some experiencing direct changes like pharmaceutical companies, others having more indirect effects such as healthcare providers.
- Animal rights organizations and activists are likely to have a high interest and perceive a significant impact, as this aligns with their goals of ethical treatment of animals.
Simulated Interviews
Pharmaceutical Researcher (San Francisco, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I believe this policy is a much-needed update to keep up with scientific advancements.
- Reducing animal testing aligns with ethical standards in research.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Healthcare Provider (New York, NY)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- The removal of animal study requirements will speed up drug availability.
- I am concerned about ensuring drug safety without animal testing.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Animal Rights Activist (Boston, MA)
Age: 62 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- This policy is a huge win for animal rights, reducing unnecessary suffering.
- I am hopeful for further legislative changes that align with ethical treatment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 5 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 7 |
| Year 10 | 10 | 8 |
| Year 20 | 10 | 9 |
Biosimilar Manufacturing Executive (Raleigh, NC)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 1/20
Statement of Opinion:
- This policy supports innovation and cost reduction in biosimilar development.
- It simplifies regulatory pathways which could reduce time to market.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 9 | 6 |
| Year 3 | 9 | 7 |
| Year 5 | 10 | 7 |
| Year 10 | 10 | 8 |
| Year 20 | 10 | 8 |
Scientist (Austin, TX)
Age: 28 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Reducing the emphasis on animal studies encourages better scientific methods.
- This policy could accelerate the adoption of modern, humane testing techniques.
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 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 10 | 8 |
Patient undergoing chronic treatment (Phoenix, AZ)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I am cautiously optimistic that this policy might make drugs more affordable.
- Ensuring the safety and efficacy of drugs is my primary concern.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Retired Pharmacist (Miami, FL)
Age: 68 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- Streamlining biosimilar approval can lead to broader access to necessary treatments.
- Patient safety should always be the top priority.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Regulatory Affairs Specialist (Denver, CO)
Age: 53 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- This policy could help harmonize US regulations with other markets globally.
- There are concerns about public perception of safety without animal testing.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
University Student of Biomedical Sciences (Seattle, WA)
Age: 22 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- The reduced reliance on animal studies is a step towards more ethical science.
- It presents opportunities for new scientific discoveries and methodologies.
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 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 10 | 8 |
Pharmaceutical Sales Representative (Houston, TX)
Age: 38 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy potentially opens up more opportunities for sales growth.
- It's essential to remain transparent about how these changes affect drug safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $7000000)
Year 2: $3000000 (Low: $2000000, High: $5000000)
Year 3: $2000000 (Low: $1000000, High: $4000000)
Year 5: $2000000 (Low: $1000000, High: $3000000)
Year 10: $1000000 (Low: $500000, High: $2000000)
Year 100: $500000 (Low: $200000, High: $1000000)
Key Considerations
- The bill may face opposition from stakeholders invested in maintaining current animal testing standards.
- Regulatory and scientific validation of alternative testing methods may require time and investment.
- International pharmaceutical regulations might influence or be influenced by this policy change.