Bill Overview
Title: To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.
Description: This bill reauthorizes through FY2027 (1) the Humanitarian Device Exemption Program (a specialized regulatory pathway for medical devices used to treat or diagnose diseases or conditions that affect no more than 8,000 individuals), and (2) the Pediatric Device Consortia Grants Program (a program that supports the development of medical devices for pediatric patients through nonprofit consortia).
Sponsors: Rep. Fletcher, Lizzie [D-TX-7]
Target Audience
Population: People with rare diseases and children requiring specialized medical devices
Estimated Size: 1000000
- The Humanitarian Device Exemption Program targets rare diseases affecting no more than 8,000 individuals per disease.
- There are numerous rare diseases; however, 8,000 is the maximum number of individuals affected per disease, implying a potentially large number when considering multiple rare diseases collectively.
- The Pediatric Device Consortia Grants Program targets development of medical devices for pediatric patients, potentially impacting children and their families worldwide.
- The global population of children is substantial, potentially influenced by this program if device development is successful.
Reasoning
- The key impact of this policy will be on people affected by rare diseases and children needing specialized medical devices. This involves evaluating both individual and broader healthcare systemic changes.
- This will encompass a varied group of stakeholders, including young children with healthcare needs, parents, individuals with rare diseases, and healthcare professionals. Additionally, companies involved in the development of these devices may also be indirectly impacted.
- Given the policy is budget-constrained, it is critical to consider how the allocated budget could effectively be utilized to maximize benefits for the largest number of people.
- It's important to also consider individuals who will not directly benefit from the policy, to provide a well-rounded understanding of its impact.
- The policy's reauthorization acts as an extension of existing efforts, providing a continuity of benefits to a currently served but also expanding reach to more newly diagnosed or previously unserved populations.
Simulated Interviews
Student (Chicago, IL)
Age: 10 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- I feel like sometimes it's hard because people don't know what I need.
- It makes me happy to have things that help me talk to my friends.
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 | 6 |
| Year 20 | 8 | 6 |
Medical Device Engineer (Houston, TX)
Age: 35 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Our work is crucial for many children and can make a big difference with more resources.
- The consistency of support will allow us to plan long-term projects.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
Parent (Los Angeles, CA)
Age: 42 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- It's always worrying about whether there will be new treatments or tools.
- Policies like this give hope to families fighting rare conditions.
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 | 8 | 5 |
| Year 20 | 7 | 5 |
Rare Disease Patient (New York, NY)
Age: 28 | Gender: other
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- Access to life-improving devices is a constant challenge.
- This policy could mean a better quality of life for people like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Pediatrician (Seattle, WA)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- I see firsthand how much these devices can change lives.
- The long-term backing facilitates continuity in patient care.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Graduate student (Miami, FL)
Age: 24 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 6/20
Statement of Opinion:
- The policy is motivating, showing there's support for new developments.
- I hope to contribute to life-changing projects for children.
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 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Health Policy Analyst (Boston, MA)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Reauthorizing support is essential to progress in rare diseases.
- It's necessary for sustaining effective device approval pathways.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Retired (Denver, CO)
Age: 67 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 3/20
Statement of Opinion:
- This policy reassures me that help will continue for my family.
- Access to devices improves our entire family dynamic.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Student (Phoenix, AZ)
Age: 14 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 6.0 years
Commonness: 4/20
Statement of Opinion:
- I'm curious about how my own equipment works and if it'll get better.
- This seems like it's good for those like me who need different medical things.
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 | 7 |
| Year 20 | 8 | 7 |
Hospital Administrator (San Francisco, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- The policy ensures continued innovation and availability of essential devices.
- We closely monitor these programs to equip our facility with cutting-edge solutions.
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 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $25000000 (Low: $20000000, High: $30000000)
Year 2: $25000000 (Low: $20000000, High: $30000000)
Year 3: $25000000 (Low: $20000000, High: $30000000)
Year 5: $25000000 (Low: $20000000, High: $30000000)
Year 10: $25000000 (Low: $20000000, High: $30000000)
Year 100: $25000000 (Low: $20000000, High: $30000000)
Key Considerations
- The programs have a defined target population, focusing on innovation for rare diseases and pediatric health.
- Costs for the programs are mainly administrative and involve awarding grants, which is straightforward to budget.
- The broader impact on healthcare costs is potential but not immediate or certain and depends on device developments.
- Revenue implications are indirect and may materialize through health sector growth over an extended period.