Bill Overview
Title: EFFECTIVE Act
Description: This bill specifies that the Food and Drug Administration may deny an application for a new opioid analgesic drug upon a determination that the drug does not provide a significant advantage or clinical superiority compared to other drugs.
Sponsors: Rep. Trone, David J. [D-MD-6]
Target Audience
Population: People who are prescribed and use opioid analgesic drugs
Estimated Size: 30000000
- Opioid misuse and addiction has been a significant public health crisis globally, impacting millions of people.
- Healthcare providers and patients are heavily involved in the prescribing and use of opioid analgesic drugs.
- Pharmaceutical companies that develop and market opioid analgesics will be directly impacted by this legislation.
- Regulatory frameworks like the FDA impact global pharmaceutical approval processes, influencing drug availability worldwide.
- The well-being of individuals suffering from chronic pain conditions may be affected if new opioid drugs are limited.
Reasoning
- The EFFECTIVE Act is designed to limit the approval of new opioid analgesics that do not offer significant improvement over existing drugs to help combat the opioid crisis.
- Given the large target population, the policy has to efficiently manage the budget constraints, focusing on high-impact areas like legality and prescription regulation.
- Healthcare providers and patients involved in opioid prescriptions are directly affected, implying their experiences and perceptions are crucial to understanding the potential impacts.
- While pharmaceutical companies will face stricter regulations, patients with chronic pain may be concerned about the availability of effective pain management solutions.
- As opioids are heavily used and misused in the US, any policy impacting their prescription will likely have broad and varied consequences on different population segments.
Simulated Interviews
Nurse (Kentucky)
Age: 54 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I think stricter regulations on opioid approvals are necessary to curb the misuse.
- However, we also need to ensure that patients genuinely in need of opioids aren't left without options.
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 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 6 | 4 |
Construction Worker (West Virginia)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- I'm worried about not having access to effective pain management.
- I understand the need for regulation but hope it considers people like me as well.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 7 |
| Year 2 | 4 | 7 |
| Year 3 | 4 | 6 |
| Year 5 | 5 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 7 | 4 |
Retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- While I see the need for this policy, educational efforts alongside it are crucial.
- Opioids should be used responsibly, but alternatives and education must be promoted.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Pharmaceutical Company Employee (California)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy could affect our business significantly.
- We may need to invest more in developing truly innovative pain management solutions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 7 |
| Year 2 | 5 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 5 |
Primary Care Physician (Ohio)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- This policy aligns well with best patient care practices.
- We should always prioritize alternative and effective treatments over more opioids.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Regulatory Affairs Specialist (New York)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- Stricter regulations will likely make approvals more challenging but more rigorous.
- Ensures only the best solutions for opioid disorders make it to market.
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 | 8 | 7 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
Graduate Student (Texas)
Age: 27 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- The EFFECTIVE Act is a step toward prioritizing public health.
- It might inspire similar policies globally if successful.
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 | 7 |
| Year 20 | 9 | 6 |
Chronic Pain Patient (Arizona)
Age: 62 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I worry about my access to pain relief amid increased regulation.
- I'm exploring alternative therapies but they don't always work.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 5 |
| Year 2 | 4 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 5 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 3 |
Pharmacy Technician (Illinois)
Age: 23 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- Reducing unnecessary opioids through policy like this is essential.
- We need consistent guidelines to help implement these changes smoothly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Substance Abuse Counselor (Oregon)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- It's crucial to address the opioid crisis through various means, including regulation.
- This policy may help reduce addiction rates significantly.
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 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
Cost Estimates
Year 1: $15000000 (Low: $10000000, High: $20000000)
Year 2: $16500000 (Low: $11000000, High: $22000000)
Year 3: $18000000 (Low: $12000000, High: $24000000)
Year 5: $21000000 (Low: $14000000, High: $28000000)
Year 10: $27000000 (Low: $18000000, High: $36000000)
Year 100: $100000000 (Low: $60000000, High: $140000000)
Key Considerations
- Balancing effective regulation with the availability of necessary pain medication.
- Ensuring FDA resources are sufficient for enhanced review processes.
- Potential impact on pharmaceutical innovation and market dynamics.
- Consideration of broader U.S. health policies targeting the opioid crisis.