Bill Overview
Title: FDASRA Act of 2022
Description: This bill reauthorizes the authority of the Food and Drug Administration to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts.
Sponsors: Sen. Burr, Richard [R-NC]
Target Audience
Population: People who use drugs, medical devices, or biosimilar products
Estimated Size: 332000000
- The FDASRA Act of 2022 involves the reauthorization of FDA's ability to collect fees related to drugs, medical devices, and biosimilar products.
- Nearly all patients interact with drugs, medical devices, or biosimilars at some point in their lifetime, particularly in developed countries such as the US.
- Manufacturers and businesses related to pharmaceuticals and medical devices will be directly affected by changes in FDA fee structures.
- Changes in fee structures could potentially impact the pricing or availability of drugs and medical devices, indirectly affecting consumers worldwide.
Reasoning
- The target population for the FDASRA Act includes nearly all Americans due to the universal interaction with the healthcare system and medical products at some point in life.
- Given the budget constraints, the direct impact in terms of fee adjustments may be most prominently felt by pharmaceutical companies, manufacturers, and healthcare facilities.
- Consumers may experience indirect effects through possible changes in drug prices and availability, thus affecting their financial and health well-being.
- To capture a broad perspective of impact, the simulated interviews will cover patients, healthcare providers, and industry representatives.
Simulated Interviews
Retired nurse (Florida)
Age: 67 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I think the policy might affect my drug prices slightly, depending on how fees are adjusted for manufacturers.
- I am worried about potential drug shortages due to possible higher costs for manufacturers.
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 | 5 | 6 |
| Year 10 | 5 | 6 |
| Year 20 | 5 | 6 |
Software developer (California)
Age: 35 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 15/20
Statement of Opinion:
- I don't expect my occasional medication use to be impacted much by the fee changes.
- Tech industry and personal health seem mostly unrelated, so I doubt there will be noticeable effects.
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 |
Medical device sales (New York)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- The policy might increase operating costs for our company, which could affect my job stability.
- Changes in fees could push companies to prioritize innovation more efficiently.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Pharmaceutical researcher (Texas)
Age: 28 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy could redirect funding on research projects towards cost management strategies.
- While fees could hinder some projects, overall innovation might get a push in managing resources wisely.
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 |
Pharmacist (Michigan)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Potential increases in drug costs due to higher fees could affect my pharmacy's pricing and customer satisfaction.
- I'm concerned about maintaining profit margins while keeping drugs affordable.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 5 |
| Year 2 | 4 | 5 |
| Year 3 | 3 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Health policy analyst (Ohio)
Age: 48 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- I believe the policy will bring necessary changes and transparency to fee allocations.
- Potential short-term industry challenges but long-term benefits for regulating the healthcare market better.
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 | 9 | 7 |
| Year 20 | 9 | 7 |
Medical device manufacturer (Illinois)
Age: 60 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Adjustments in fees could increase production costs, possibly affecting our customer pricing.
- The act may place pressure on smaller firms, but it could foster market consolidation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 4 | 5 |
| Year 3 | 4 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Retired teacher (Arizona)
Age: 72 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- I'm concerned whether this policy might cause me to pay more for my medication or if there will be reforms in Medicare.
- Senior citizens might feel vulnerable if drug pricing shifts dramatically.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 5 | 6 |
| Year 5 | 5 | 6 |
| Year 10 | 5 | 6 |
| Year 20 | 5 | 6 |
Primary care physician (Massachusetts)
Age: 30 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- I expect possible price changes to ease after initial policy adjustments.
- This could urge manufacturers to focus on competitive pricing and patient benefits.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Biotech startup CEO (Colorado)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Our early-stage development might face cost challenges with additional fees.
- Long-term industry changes could streamline regulatory processes and foster innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 5 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $50000000 (Low: $40000000, High: $60000000)
Year 2: $51000000 (Low: $41000000, High: $61000000)
Year 3: $52000000 (Low: $42000000, High: $62000000)
Year 5: $54000000 (Low: $44000000, High: $64000000)
Year 10: $56000000 (Low: $46000000, High: $66000000)
Year 100: $60000000 (Low: $50000000, High: $70000000)
Key Considerations
- The reauthorization of FDA fees is primarily a continuation of existing policy, with fee modifications to reflect current market conditions and cost requirements.
- The financial effects predominantly impact FDA funding mechanisms rather than creating new fiscal obligations.
- Important considerations include industry adaptability to the modified fee structures and how these costs are passed onto consumers.