Bill Overview
Title: Accelerated Approval Integrity Act of 2022
Description: This bill establishes requirements relating to postapproval studies for drugs that receive accelerated approval for serious or life-threatening diseases or conditions, such as requiring product sponsors to agree in advance to conduct such studies and terminating product approval if certain benchmarks are not met.
Sponsors: Rep. Pallone, Frank, Jr. [D-NJ-6]
Target Audience
Population: Individuals with serious or life-threatening conditions needing accelerated drug approval
Estimated Size: 5000000
- Accelerated Approval is a pathway used primarily for serious or life-threatening diseases where there is an unmet clinical need.
- The legislation impacts those who rely on drugs approved through this pathway.
- These individuals typically suffer from serious or life-threatening conditions such as cancer, HIV/AIDS, or ALS.
- These conditions require rapid access to treatment options that can extend or improve lives.
- Globally, serious diseases affect millions; for example, cancer alone affects roughly 19 million people worldwide annually.
Reasoning
- Considering the budget of the policy, not all individuals with serious conditions will be directly impacted, especially in the initial years.
- The policy is designed to ensure the safety and efficacy of treatments, impacting those who rely on accelerated approvals for continuity in their medication regimens.
- With five million Americans potentially impacted, the policy will particularly affect those currently on or needing drugs undergoing accelerated approval.
- The Cantril Self-Anchoring Scale will help gauge perceptions of wellbeing among those both affected and unaffected directly.
- The budget limits suggest that the policy can only provide support up to a certain number of individuals concurrently.
- The simulation includes a range of individuals from those directly impacted by accelerated drug paths to those less immediately impacted but within the broader demographics affected.
Simulated Interviews
nurse (Chicago, IL)
Age: 56 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I am hopeful about my treatment but concerned about the study's demands.
- The policy seems like a good step to ensure drug safety; however, it should not delay access.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
software developer (Miami, FL)
Age: 45 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- It's vital to know the drugs are safe long-term; rapid approval is critical for us.
- I am happy the policy enforces more transparency but worried about drug withdrawal.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 7 | 6 |
retired teacher (San Francisco, CA)
Age: 63 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This policy gives hope for better oversight of the treatments I rely on.
- But the accelerated approvals process must remain swift for ALS therapies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 5 | 4 |
fitness trainer (Houston, TX)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I appreciate the emphasis on safety; it's reassuring.
- The policy must be careful not to stifle new treatment access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
pharmaceutical researcher (Denver, CO)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Balancing safety and speedy access for patients is crucial.
- The policy might increase costs and time for research developments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 8 |
| Year 10 | 8 | 9 |
| Year 20 | 7 | 8 |
healthcare advocate (New York, NY)
Age: 42 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 18/20
Statement of Opinion:
- The policy is a double-edged sword; necessary but should not make access tougher.
- I'm advocating for better awareness and understanding of these changes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 10 |
| Year 20 | 9 | 7 |
journalist (Los Angeles, CA)
Age: 39 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- This policy is likely to draw a lot of industry attention.
- Balancing public health and commercial interests will be key.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 9 |
| Year 20 | 7 | 7 |
biotech CEO (Seattle, WA)
Age: 51 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- While safety is essential, the timing is concerning for our operations.
- More guidance from regulatory bodies on implementation would be helpful.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 6 | 7 |
| Year 20 | 5 | 6 |
patient advocate (Detroit, MI)
Age: 47 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- Policies like this are necessary but could slow down approvals.
- Patients must have ongoing dialogue with policymakers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 10 |
| Year 10 | 9 | 10 |
| Year 20 | 8 | 9 |
medical researcher (Raleigh, NC)
Age: 37 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- The policy shifts focus on long-term data integrity—not just short-term gains.
- Could push research into more validated avenues.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $25000000 (Low: $15000000, High: $35000000)
Year 2: $20000000 (Low: $12000000, High: $28000000)
Year 3: $15000000 (Low: $9000000, High: $21000000)
Year 5: $15000000 (Low: $9000000, High: $21000000)
Year 10: $15000000 (Low: $9000000, High: $21000000)
Year 100: $15000000 (Low: $9000000, High: $21000000)
Key Considerations
- Maintaining drug prices is crucial as new standards might increase development costs.
- Healthcare providers and patients must be closely involved to ensure benchmarks align with real patient outcomes.
- Additional regulatory compliance may deter smaller pharmaceutical firms from entering the market.