Bill Overview
Title: Food and Drug Amendments of 2022
Description: This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars. The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials. In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.
Sponsors: Rep. Eshoo, Anna G. [D-CA-18]
Target Audience
Population: People who use prescription drugs, medical devices, generic drugs, and biosimilars
Estimated Size: 220000000
- The bill impacts manufacturers of prescription drugs, devices, generic drugs, and biosimilars due to the continuation and modification of FDA user fee programs.
- Patients who use prescription drugs, generic drugs, biosimilars, and medical devices globally will be impacted by changes in the availability, quality, and safety of these products.
- The bill aims to increase diversity in clinical trials which impacts participants in such trials and could lead to improved healthcare outcomes for diverse populations worldwide.
- Healthcare professionals involved in prescribing and managing drug therapies and devices will be impacted due to changes in drug approvals and real-world evidence usage.
- Global supply chain modifications for drugs and devices as required by the bill will impact international producers, distributors, and consumers of these products.
Reasoning
- The policy targets a large population, considering 220 million Americans use prescription drugs and medical devices. These individuals represent diverse demographics and are spread across different regions and occupations.
- The key impacted groups are patients, healthcare professionals, manufacturers, and trial participants. As such, simulated persons include these categories to provide a good distribution.
- Budget constraints restrict immediate, large-scale impacts; initially, only moderate changes might be noticeable, gradually increasing over time with sustained funding and infrastructure adjustments.
- Diversity initiatives in clinical trials may not directly impact all patients immediately but could lead to broader, long-term benefits for diverse populations.
- Program size limits and budgetary constraints mean not every individual's wellbeing will be immediately affected, especially given the policy focuses on systemic changes that may take time to manifest impactful results.
Simulated Interviews
pharmaceutical research scientist (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- I believe the policy will improve clinical trial outcomes due to increased diversity, potentially leading to better drugs.
- There might be some initial pushback from companies due to changes in trial requirements.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
patient: insulin-dependent diabetic (Austin, TX)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- Any policy that could stabilize or reduce drug prices is welcome.
- There's always a concern about generic drug availability, so improved communication from FDA could help calm these worries.
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 | 7 | 6 |
| Year 20 | 6 | 5 |
cardiologist (Chicago, IL)
Age: 60 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- Streamlining approvals could greatly benefit my patients' options.
- I appreciate the emphasis on real-world evidence in supporting applications.
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 | 9 | 8 |
| Year 20 | 9 | 8 |
clinical trial participant (San Francisco, CA)
Age: 37 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy could ease entry and encourage more diverse participation which is essential.
- It's a long-needed move for better representation in trials.
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 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
generic drug manufacturer (Miami, FL)
Age: 52 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- It's good that FDA is becoming more informative about generic approvals.
- Additional fees and compliance costs are a concern though.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 6 | 7 |
| Year 20 | 6 | 7 |
nurse practitioner (Seattle, WA)
Age: 33 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- Diversity in clinical trials could mean more appropriate drug options for my patients.
- I hope these changes speed up new, effective treatments being available.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
FDA regulatory affairs specialist (Atlanta, GA)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The push for real-world evidence could streamline processes.
- Increased workload is expected but manageable with the right adjustments.
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 | 8 | 7 |
| Year 20 | 7 | 6 |
medical device engineer (Denver, CO)
Age: 28 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- The policy's emphasis on pediatric devices is beneficial.
- Regulatory adjustments could encourage more innovation.
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 |
biopharmaceutical executive (Los Angeles, CA)
Age: 39 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Balancing safety and innovation is challenging but necessary.
- FDA's supportive regulations can enhance our competitive edge globally.
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 | 8 | 8 |
| Year 20 | 8 | 7 |
public health official (Boston, MA)
Age: 55 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy supports my goals for more inclusive healthcare.
- Evidence-based strategies help in policy making and public trust.
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 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Cost Estimates
Year 1: $200000000 (Low: $180000000, High: $220000000)
Year 2: $205000000 (Low: $185000000, High: $225000000)
Year 3: $210000000 (Low: $190000000, High: $230000000)
Year 5: $220000000 (Low: $200000000, High: $240000000)
Year 10: $250000000 (Low: $230000000, High: $270000000)
Year 100: $300000000 (Low: $280000000, High: $320000000)
Key Considerations
- Consistent funding for the FDA user fee programs is crucial for effective drug and device regulation.
- Balancing the cost of clinical trial diversity enhancements with the long-term benefits to healthcare quality and inclusivity is essential.
- Efforts to revamp the supply chain will involve significant initial expenditure but can lead to supply stability benefits.
- Navigating the transition to using real-world evidence in regulatory processes will require substantial operational adjustments.