Bill Overview
Title: FDASLA Act of 2022
Description: This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process; requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA; requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets; requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.
Sponsors: Sen. Murray, Patty [D-WA]
Target Audience
Population: People worldwide using FDA-regulated drugs, medical devices, cosmetics and dietary supplements
Estimated Size: 331000000
- The bill impacts products commonly used by the general public, including drugs, medical devices, cosmetics, and dietary supplements.
- Cosmetic and dietary supplement manufacturers will be required to provide more information to the FDA, potentially impacting how these products are marketed and distributed.
- Patients who rely on drugs, including biosimilars, will be affected by changes in the approval processes, including accelerated approval for serious conditions, which could influence the availability of new treatments.
- The regulation of in vitro clinical tests will affect healthcare providers and labs that develop or use these tests.
Reasoning
- The FDASLA Act of 2022 will have varying impacts on the population segments. Some groups will benefit from improved regulations and safety standards, while others may face increased costs due to new compliance requirements.
- People using cosmetics and dietary supplements constitute a large segment of the U.S. population, but only a subset is likely to notice a significant impact on their wellbeing scores.
- Healthcare professionals and those with serious illnesses may experience a moderate impact due to changes in drug approval processes and the regulation of in vitro tests.
- The budget constraints suggest a focus on impactful but cost-effective implementations, potentially prioritizing systemic changes with wide-reaching benefits without substantially increasing costs to the end consumer.
- The policy's impact will differ across individuals based on their personal interactions with FDA-regulated products. Those with limited use of these products (e.g., cosmetics, supplements) may see little to no change in their wellbeing.
Simulated Interviews
Cosmetic Manufacturer (Los Angeles, CA)
Age: 34 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The increased regulations are necessary for safety, but they will increase business costs, which may affect product pricing.
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 | 6 | 7 |
| Year 10 | 6 | 7 |
| Year 20 | 6 | 7 |
Pharmaceutical Researcher (Austin, TX)
Age: 45 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- The accelerated approval process is critical for bringing important medications to patients more quickly.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cosmetic Consumer (Miami, FL)
Age: 26 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- Knowing that the FDA will enforce new safety standards on cosmetics gives me peace of mind.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Dietary Supplement Producer (Chicago, IL)
Age: 53 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- These regulations will increase our manufacturing costs, and we must adjust our prices accordingly.
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 |
Retiree (Seattle, WA)
Age: 68 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- Any changes that might lead to higher drug prices are worrying on a fixed income.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 4 | 5 |
| Year 20 | 4 | 5 |
Laboratory Scientist (New York, NY)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- The need for FDA approval of in vitro tests is a necessary step toward ensuring public health safety.
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 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Healthcare Policy Analyst (San Francisco, CA)
Age: 30 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- These changes are a positive step towards improving public health standards.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
College Student (Boston, MA)
Age: 22 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- Streamlining the drug approval process can revolutionize access to new therapies.
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 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Small Business Owner (Phoenix, AZ)
Age: 50 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Concerned that increased regulatory compliance could impact business operations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 4 | 5 |
| Year 20 | 4 | 5 |
Stay-at-Home Parent (Raleigh, NC)
Age: 37 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- I appreciate that the FDA is taking steps to ensure our health supplements are safe.
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 | 6 | 7 |
| Year 20 | 6 | 7 |
Cost Estimates
Year 1: $300000000 (Low: $250000000, High: $350000000)
Year 2: $350000000 (Low: $300000000, High: $400000000)
Year 3: $350000000 (Low: $300000000, High: $400000000)
Year 5: $275000000 (Low: $225000000, High: $325000000)
Year 10: $100000000 (Low: $75000000, High: $125000000)
Year 100: $50000000 (Low: $40000000, High: $60000000)
Key Considerations
- The FDA's enhanced regulatory authority will require robust oversight mechanisms to ensure proper implementation without unnecessary delays.
- Industry adaptation to new regulations might affect product prices and availability in the short term.
- Long-term public health benefits could offset initial costs through improved population health outcomes.