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: Sen. Manchin, Joe, III [D-WV]
Target Audience
Population: People using or potentially using opioid analgesics for pain management
Estimated Size: 10000000
- The FDA is responsible for the regulation of drugs, including opioid analgesics, in the United States.
- Opioid analgesics are commonly prescribed for pain management and are used globally.
- The act targets new opioid analgesic drugs, suggesting that it primarily concerns pharmaceutical manufacturers producing these drugs.
- People who suffer from chronic pain and might be prescribed opioid analgesics are the end users of these drugs.
Reasoning
- The EFFECTIVE Act's budget constraints mean that its application will be fairly limited, likely impacting a fraction of the 10 million estimated American opioid users.
- The Act is meant to reduce opioid addiction and misuse by limiting approvals of less effective or redundant opioid drugs.
- Many users of opioid analgesics for chronic pain may not be directly affected if they are not using newly developed drugs.
- The policy will primarily affect the pharmaceutical companies introducing new drugs rather than existing users of opioid analgesics.
- Wellbeing scores will likely only improve if the policy effectively reduces future opioid crisis burdens or if individuals find equally effective alternative pain management strategies.
Simulated Interviews
retired teacher (West Virginia)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 1.0 years
Commonness: 10/20
Statement of Opinion:
- I'm worried that this policy might limit options for pain relief and could make it harder for people like me to manage pain.
- I understand the intent to curb opioid misuse, but there are people who genuinely need effective pain medication.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 5 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 3 |
software engineer (California)
Age: 30 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 15/20
Statement of Opinion:
- Limiting ineffective opioids makes sense. As someone who uses these occasionally, knowing they're only approved if they work better than existing options is reassuring.
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 | 8 | 8 |
| Year 20 | 8 | 8 |
pharmacy technician (Kentucky)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 8/20
Statement of Opinion:
- This could be really good if it reduces opioid abuse in my community.
- But, I worry about patients who genuinely need pain relief and if they’ll be affected.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 4 |
opioid recovery counselor (Texas)
Age: 28 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 7/20
Statement of Opinion:
- This act could prevent a new wave of opioid dependences by only approving truly superior medications.
- It aligns with the work I do, which often highlights the need for better regulation.
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 | 7 | 5 |
| Year 20 | 7 | 4 |
retired nurse (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 1.0 years
Commonness: 12/20
Statement of Opinion:
- If the policy leads to safer and more effective drugs, it's beneficial.
- My pain management needs existing drugs, so unless old ones are rescinded, my daily life isn't affected.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 4 |
research scientist in pharmaceuticals (New York)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy might slow down innovation by adding more regulatory challenges, but it could also push for truly innovative solutions.
- We absolutely need more effective regulations to tackle opioid misuse.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
chronic pain patient advocate (Ohio)
Age: 50 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 1.5 years
Commonness: 8/20
Statement of Opinion:
- I'm concerned about the limitations this could place on pain management options available for chronic pain sufferers.
- While well-intentioned, I hope the policy considers cases where new drugs are genuinely needed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 4 | 4 |
| Year 3 | 4 | 4 |
| Year 5 | 4 | 3 |
| Year 10 | 4 | 3 |
| Year 20 | 4 | 3 |
small business owner (Oregon)
Age: 34 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 1.5 years
Commonness: 10/20
Statement of Opinion:
- Fewer but more effective medications could reduce confusion and side effects for users.
- I hope this policy means any costs associated with new drugs are justified by their effectiveness.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
retired factory worker (Maine)
Age: 60 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 9/20
Statement of Opinion:
- I’ve seen too many friends get hooked on these drugs. Anything that makes it harder for unnecessary opioids to hit the market is positive.
- I worry though if this will mean less pain relief for genuine cases.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 3 |
ER nurse (Illinois)
Age: 38 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 2.5 years
Commonness: 8/20
Statement of Opinion:
- This can be a vital step towards reducing the number of opioids in circulation and the potential for misuse.
- I'm optimistic, but it's critical the policy doesn't inadvertently neglect those who need controlled, effective access to pain relief.
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 | 6 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 3 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $30000000)
Year 2: $20000000 (Low: $15000000, High: $30000000)
Year 3: $20000000 (Low: $15000000, High: $30000000)
Year 5: $20000000 (Low: $15000000, High: $30000000)
Year 10: $20000000 (Low: $15000000, High: $30000000)
Year 100: $20000000 (Low: $15000000, High: $30000000)
Key Considerations
- The FDA will need additional resources to implement the enhanced criteria for opioid approvals.
- The potential reduction in opioid prescriptions could lead to positive public health outcomes.
- There is a risk of increased litigation from pharmaceutical companies that have applications denied.
- Long-term healthcare savings could outweigh the initial increased costs for regulatory processes.