Bill Overview
Title: Accelerating Access for Patients Act of 2022
Description: This bill modifies requirements relating to accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring guidance from the Food and Drug Administration and coordinated plans with product sponsors on appropriate postapproval studies.
Sponsors: Rep. McMorris Rodgers, Cathy [R-WA-5]
Target Audience
Population: people with serious or life-threatening diseases
Estimated Size: 50000000
- The bill focuses on drugs for serious or life-threatening diseases, which can affect any person globally since these conditions are widespread.
- Chronic diseases, cancers, and rare diseases are some of the conditions that might need accelerated drug approval. These conditions do not know borders.
- Serious and life-threatening diseases affect millions of people globally.
Reasoning
- The policy primarily targets individuals with serious or life-threatening diseases, as these patients would benefit significantly from faster access to potentially life-saving drugs.
- The budget limits mean the policy can only support a portion of affected individuals annually, focusing on those with the most critical needs or for whom new treatments are emerging.
- Many people have conditions that can be severe and life-threatening, like cancer, cardiovascular disease, and rare genetic disorders, thus they might be included in the target group.
- The Cantril wellbeing scores reflect both physical health and peace of mind; improvements indicate better health outcomes or reduced stress due to increased access to treatments.
- A range of responses is necessary because not every person with these conditions might be directly impacted; some might not find immediate new treatments developed or released.
- The policy has a substantial budget but must prioritize innovations that can yield the most significant potential benefits in wellbeing across diverse populations.
Simulated Interviews
Retired teacher (Seattle, WA)
Age: 67 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I really hope this policy can get drugs approved more quickly.
- It gives me hope that there might be more options soon.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 3 |
| Year 5 | 7 | 3 |
| Year 10 | 6 | 2 |
| Year 20 | 4 | 1 |
Software engineer (Houston, TX)
Age: 45 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I hope this policy speeds up access to new treatments for my condition.
- Any improvement in drug approval systems gives us hope for better lives.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 5 | 3 |
| Year 3 | 5 | 3 |
| Year 5 | 6 | 3 |
| Year 10 | 7 | 3 |
| Year 20 | 5 | 2 |
PhD student (San Francisco, CA)
Age: 29 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- While my current treatment is managed, the prospect of better drugs faster is promising.
- Supporting drug innovation is vital for managing lifelong diseases.
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 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Construction worker (Miami, FL)
Age: 52 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- I'm hopeful that new developments can slow my disease progression.
- Policies that accelerate access to treatments are essential for people like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 5 | 3 |
Healthcare consultant (Chicago, IL)
Age: 35 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 15.0 years
Commonness: 7/20
Statement of Opinion:
- Increasing access to innovative drugs could significantly affect my treatment outcomes.
- I support the idea of more comprehensive plans post-approval.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 3 |
| Year 10 | 8 | 2 |
| Year 20 | 6 | 1 |
College professor (Boston, MA)
Age: 40 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- The policy could bring treatments sooner, potentially alleviating symptoms.
- I think it's crucial to involve patients in post-approval processes to ensure needs are met.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 4 |
Retired nurse (Phoenix, AZ)
Age: 65 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- I'm encouraged by efforts to improve access to treatments for others who are still fighting.
- The continuance of research and development is pivotal.
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 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Truck driver (Denver, CO)
Age: 58 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- New treatments changing the game for heart conditions could directly affect my life.
- Better drug policies are vital for those on the brink.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 9 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 5 | 3 |
Digital marketer (Los Angeles, CA)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- The acceleration of drug approvals is critical for people with CF.
- Mitigating delays in access to treatment could change lives drastically.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 4 |
Artist (New York, NY)
Age: 55 | Gender: other
Wellbeing Before Policy: 3
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- Access to better treatments could significantly improve my quality of life.
- Policies that support innovation in treatment are worth investing in.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 5 | 3 |
| Year 3 | 6 | 3 |
| Year 5 | 6 | 2 |
| Year 10 | 7 | 1 |
| Year 20 | 5 | 1 |
Cost Estimates
Year 1: $200000000 (Low: $150000000, High: $250000000)
Year 2: $210000000 (Low: $160000000, High: $260000000)
Year 3: $220000000 (Low: $170000000, High: $270000000)
Year 5: $240000000 (Low: $190000000, High: $290000000)
Year 10: $300000000 (Low: $250000000, High: $350000000)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Ensuring rigorous safety standards remain intact during the acceleration of drug approvals.
- Potential shifts in market dynamics for drug pricing and availability.
- Impact on domestic vs. international pharmaceutical companies and their activities in the U.S. market.