Bill Overview
Title: FORWARD Act of 2022
Description: This bill establishes programs to support research on endemic fungal diseases and the development of antifungal drugs, with a particular focus on Valley Fever. Endemic fungal diseases are fungal infections that tend to occur in specific geographic areas and affect older adults and other at-risk populations. Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' efforts to address endemic fungal diseases. The working group is comprised of experts from both relevant federal agencies and the private sector. In addition, the National Institutes of Health must continue its support for research on endemic fungal diseases. Furthermore, the Food and Drug Administration must issue guidance for entities seeking approval for therapies, diagnostics, and vaccines to prevent and treat Valley Fever. Additionally, the bill provides for the use of priority reviews and other fast-track procedures to incentivize and expedite development and approval of these medical products. The bill also requires the Biomedical Advanced Research and Development Authority to implement the Combating Antimicrobial Resistance Biopharmaceutical Accelerator Program to reduce and prevent antimicrobial resistance.
Sponsors: Sen. Kelly, Mark [D-AZ]
Target Audience
Population: People living in regions endemic with fungal diseases
Estimated Size: 5000000
- Valley Fever and other endemic fungal diseases particularly affect specific geographic areas, with Valley Fever prevalent in the southwestern United States.
- These diseases tend to affect older adults, people with weakened immune systems, and those with certain preexisting health conditions.
- The percentage of the global population affected by endemic fungal diseases is relatively low, but these regions have millions of residents.
- The full global target group includes those living in endemic areas worldwide, with specific focus on regions similar to the southwestern United States, accounting for potentially affected populations in other countries too.
Reasoning
- The policy targets research and treatment development for endemic fungal diseases, emphasizing Valley Fever. Considering its distribution primarily affects the southwestern United States, especially in places like Arizona and California.
- Valley Fever is especially prevalent among older adults and people with compromised immune systems, such as those undergoing treatments for organ transplants, cancer patients, and individuals with chronic illnesses.
- The American target population is estimated at 5 million, primarily residents in areas almost endemic to Valley Fever such as parts of Southern California and Arizona.
- Policy prioritizes research, fast-track approval, and biopharmaceutical enhancements that are meant to accelerate medicines' availability, impacting quality of life positively for targeted populations.
- The budget is structured to ensure efficient research while tackling persistent challenges in disease treatment and normal rating issued in R&D costs.
- There is an explicit need to include perspectives ranging from those directly affected to peripheral groups minimally influenced by the policy for a holistic impact analysis.
Simulated Interviews
Retired teacher (Phoenix, Arizona)
Age: 65 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The policy sounds promising, especially if it leads to more effective treatments for Valley Fever, which has affected my health significantly.
- I am optimistic about increased funding for research; it could lead to better medications and fewer side effects.
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 | 8 | 4 |
| Year 10 | 9 | 3 |
| Year 20 | 8 | 3 |
Retired agricultural worker (Tucson, Arizona)
Age: 72 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- Living in a hot spot for Valley Fever, it's necessary to have more focused research and treatments.
- I hope this brings relief quicker, since my condition complicates recovery from infections.
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 | 7 | 3 |
| Year 10 | 7 | 2 |
| Year 20 | 8 | 1 |
Nurse (San Joaquin Valley, California)
Age: 40 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 5/20
Statement of Opinion:
- Being frontline medical staff, I see firsthand how Valley Fever impacts patients. It's encouraging that more will be done to address it.
- Accelerated drug approvals can drastically improve how we manage these cases locally.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 8 | 4 |
Construction worker (Riverside, California)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 2/20
Statement of Opinion:
- It's reassuring knowing developments in treatments are being fast-tracked; prevention and cure must be a priority.
- Knowing there are structured efforts in place is comforting when working in high-risk areas.
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 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Software developer (New York City, New York)
Age: 31 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- For someone like me, living far from areas of prevalence, the policy has little direct impact.
- However, it represents a positive direction in public health commitments overall.
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 |
Full-time caregiver (San Diego, California)
Age: 47 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Improved drug availability and fast-tracked solutions can potentially improve the living conditions of those I care for.
- Prevention-focused policies like this could significantly ease long-term caregiving.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
Grad student (Los Angeles, California)
Age: 29 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- It's crucial that neglected diseases gain this level of attention and funding—could change future health strategies.
- Increasing public awareness is necessary alongside drug development.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Part-time librarian (Fresno, California)
Age: 66 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 1/20
Statement of Opinion:
- Hope the bill speeds up finding more effective preventive measures, especially for vulnerable elders.
- Research could lead to breakthroughs in how we address similar infections.
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 | 8 | 3 |
| Year 10 | 8 | 3 |
| Year 20 | 8 | 3 |
Educator (Houston, Texas)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Having had Valley Fever and recovering, emphasis on new preventive strategies matter most to me.
- Additional options being fast-tracked reassures me that effective prevention is forthcoming.
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 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Retired geologist (Flagstaff, Arizona)
Age: 76 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 1/20
Statement of Opinion:
- Policy feels like a long-overdue action. Scientific advancement could finally offer relief to longstanding issues.
- Local health initiatives can benefit greatly from any federal support formalized through this policy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Cost Estimates
Year 1: $150000000 (Low: $120000000, High: $180000000)
Year 2: $150000000 (Low: $120000000, High: $180000000)
Year 3: $160000000 (Low: $130000000, High: $190000000)
Year 5: $170000000 (Low: $140000000, High: $200000000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- A significant portion of targeted diseases is geographically limited, which may localize immediate impacts.
- Coordination efforts between federal agencies and the private sector are crucial for effective implementation.
- Potential risks of antimicrobial resistance necessitate substantial R&D investments and collaboration.
- Long-term savings depend on the successful development and approval of effective treatments.