Bill Overview
Title: Give Kids a Chance Act of 2022
Description: Give Kids a Chance Act This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).
Sponsors: Rep. Butterfield, G. K. [D-NC-1]
Target Audience
Population: Children with cancer
Estimated Size: 16000
- Pediatric cancer patients are the primary beneficiaries, as they will have access to potentially more effective treatment combinations through mandated trials.
- There are approximately 400,000 new cases of pediatric cancer globally each year. Though not all will be eligible for or directly affected by trials, these patients represent the global target of such regulatory actions.
- The FDA's actions impact global pharmaceutical company strategies, affecting all patients supported by drugs developed with the US market in mind.
Reasoning
- Pediatric cancer patients in the U.S. number about 16,000 annually, but not all will directly participate in new trials. Indirect benefits may occur due to improved treatment options being available sooner.
- Urban areas with large medical centers might see more direct impacts due to proximity to research hospitals conducting trials.
- Families with children currently under treatment may have immediate interest in trial eligibility and outcomes.
- Socioeconomic status plays a role; families with better resources might access new treatments faster.
- Medical professionals and researchers are key stakeholders; they are not directly benefitted as patients but are crucial in implementing policy.
- Pharmaceutical companies face changed drug development timelines and procedures, impacting strategy and potentially pricing.
Simulated Interviews
N/A (Seattle, WA)
Age: 7 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- The policy gives hope because there might be more drugs available sooner.
- My family is anxious about trial side effects.
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 | 6 |
| Year 20 | 7 | 5 |
Oncologist (Phoenix, AZ)
Age: 38 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 4/20
Statement of Opinion:
- This policy could lead to breakthroughs faster.
- The administrative load may increase initially.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Pharmaceutical executive (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Requires shift in strategy, but access to markets will grow.
- Increased R&D costs are a concern.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
School teacher (Chicago, IL)
Age: 52 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Hopes for new treatment options.
- Worried about accessibility of new drugs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 7 | 4 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
Farmer (Rural Kansas)
Age: 62 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 5/20
Statement of Opinion:
- Unlikely to be directly impacted by the policy.
- Concerned about overall healthcare system costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Clinical trial coordinator (San Francisco, CA)
Age: 29 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- The policy could increase work but also benefit the complexity and reach of trials.
- There's optimism about recruiting participants more easily.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
N/A (Miami, FL)
Age: 10 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Not directly understanding the policy.
- Parents express optimism due to potential new treatments.
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 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Software engineer (Austin, TX)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- The policy lends hope for more tailored treatment options.
- The focus on pediatrics is reassuring but questions about inclusivity remain.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Nurse (Boston, MA)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 4/20
Statement of Opinion:
- There's potential for better outcomes due to the policy.
- Staff workload around trial participation may increase.
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 | 7 |
| Year 20 | 7 | 7 |
Policy analyst (Los Angeles, CA)
Age: 55 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Sees strategic global impact on drug trial regulations.
- Cautions about resource allocation challenges if the policy is not managed well.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Cost Estimates
Year 1: $500000000 (Low: $400000000, High: $600000000)
Year 2: $520000000 (Low: $420000000, High: $620000000)
Year 3: $540000000 (Low: $440000000, High: $640000000)
Year 5: $600000000 (Low: $500000000, High: $700000000)
Year 10: $700000000 (Low: $600000000, High: $800000000)
Year 100: $1000000000 (Low: $900000000, High: $1100000000)
Key Considerations
- The impact on pharmaceutical companies' research and development strategies could be substantial.
- There is a potential risk of higher drug costs due to increased trial requirements.
- The administration of such programs would need stringent monitoring and evaluation by the FDA.