Bill Overview
Title: GAIN TOOLS Act of 2022
Description: This bill expands the definition of a qualified infectious disease product (QIDP) to include eligible biological products. Under current law, the first application (or supplement) for a specific product and indication to be designated a QIDP shall receive priority review for market approval by the Food and Drug Administration. Generally, a biological product designated as a QIDP is one that acts on bacteria or fungi and is intended to treat a serious or life-threatening infection. However, a biological product with a QIDP designation shall not receive the market exclusivity extension currently available to drugs that receive the designation.
Sponsors: Sen. Casey, Robert P., Jr. [D-PA]
Target Audience
Population: People suffering from serious or life-threatening bacterial or fungal infections
Estimated Size: 5000000
- The bill impacts patients suffering from serious or life-threatening bacterial or fungal infections, as biological products that act on these diseases would now be expedited for market review if designated as QIDPs.
- Expanding the definition of QIDPs to include biological products could lead to faster availability of these treatments globally.
- Healthcare providers treating serious infections may gain access to a wider range of treatment options due to this act.
- The pharmaceutical and biotech industries are stakeholders impacted due to changes in regulation around product approval processes.
Reasoning
- The GAIN TOOLS Act expands the QIDP designation to include biological products, potentially affecting patients with conditions treatable by these products and healthcare providers who treat infections.
- The policy aims to expedite availability of biological products for serious infections which could improve patient treatment outcomes, but it does not provide market exclusivity, limiting some financial incentives for manufacturers.
- Considering the target population, this policy mostly impacts those with severe infections likely to benefit directly from such products, such as immunocompromised individuals or those in hospitals.
- Some individuals, like employees in the pharmaceutical industry, might perceive indirect impacts due to changes in drug approval strategies.
- Many individuals not suffering from severe infections or not working in relevant industries will likely remain unaffected directly by this policy.
Simulated Interviews
Retiree (New York, NY)
Age: 65 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I believe it's crucial to have faster approvals for new treatments, especially for people like me who are more vulnerable to infections.
- This policy might bring hope to those awaiting new treatments for antibiotic-resistant infections.
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 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Infectious disease specialist (Chicago, IL)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Access to newer biological products could significantly improve treatment success rates in my practice.
- However, the lack of market exclusivity might limit the number of products that actually reach us.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Biotech employee (San Francisco, CA)
Age: 32 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- This might boost our development pipeline for biological treatments.
- I am not directly affected health-wise, but it could mean new projects and opportunities for my company.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Diabetes patient (Houston, TX)
Age: 58 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 7.0 years
Commonness: 9/20
Statement of Opinion:
- I'm constantly worried about contracting infections and resistance issues.
- Knowing that there might soon be more treatment options is reassuring.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 4 |
Stay-at-home parent (Miami, FL)
Age: 39 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 20/20
Statement of Opinion:
- I haven't been affected by serious infections, so this doesn't immediately impact me.
- It's good to know progress is happening in healthcare, though.
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 |
Pharmaceutical executive (Boston, MA)
Age: 51 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 8/20
Statement of Opinion:
- It's a step forward for the industry, but without exclusivity, the financial motivator for developing QIDP-designated biologicals is still lacking.
- Our company might need to adjust our strategies to align with this policy.
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 | 7 | 6 |
| Year 20 | 7 | 6 |
Research scientist (Seattle, WA)
Age: 28 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- This policy can provide a further impetus for our team to push certain projects towards clinical trials submission.
- It's about opening up as many options as possible for patients.
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 | 5 |
Retired teacher (Phoenix, AZ)
Age: 70 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 6.0 years
Commonness: 12/20
Statement of Opinion:
- Recently had a tough time with pneumonia; it was scary given antibiotic resistance concerns.
- I'm hopeful that the policy will enable better treatments to be there when needed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 4 |
General practitioner (Kansas City, MO)
Age: 41 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 14/20
Statement of Opinion:
- This policy is promising as it might widen my treatment arsenal.
- However, translating policy into practical drug availability often takes time.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Public health official (Denver, CO)
Age: 34 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- From a public health perspective, this policy is a needed adjustment given global shifts in infectious disease trends.
- Ensuring treatments reach people efficiently is part of our changing strategies.
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 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $7000000)
Year 2: $5200000 (Low: $3100000, High: $7300000)
Year 3: $5400000 (Low: $3300000, High: $7600000)
Year 5: $5800000 (Low: $3500000, High: $8000000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The impact of the bill on public health through quicker approval of necessary treatments.
- Budgetary implications of additional FDA resource allocation and staffing for expedited reviews.
- Anticipated effects on healthcare savings related to treating and managing infections.