Bill Overview
Title: DEPICT Act
Description: This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.) Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities. The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups. The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.
Sponsors: Rep. Eshoo, Anna G. [D-CA-18]
Target Audience
Population: Individuals participating in clinical trials
Estimated Size: 500000
- The DEPICT Act focuses on increasing demographic diversity in clinical trials, affecting people who participate in these trials.
- This bill addresses underrepresentation of various demographic subgroups, such as different age groups, sexes, races, and ethnicities, in clinical trials.
- Globally, the pharmaceutical and medical device sectors conduct clinical trials across various countries, involving a large number of participants.
- Diverse groups in clinical trials lead to more comprehensive data on drug and device effectiveness and safety, impacting global health outcomes.
Reasoning
- The DEPICT Act primarily affects individuals involved in clinical trials in the United States.
- The policy is designed to ensure demographic diversity, which can impact trial participants positively by providing more tailored and effective healthcare solutions.
- Not all clinical trial participants will feel the impact of the policy equally, as some may already be part of diverse trials or may not recognize the long-term benefits.
- The budget constraints require the policy to be implemented efficiently, focusing on trials with significant diversity issues or large participant pools.
- Wellbeing improvements over time may be more pronounced in populations who historically lacked representation, such as certain racial or ethnic groups.
Simulated Interviews
Clinical Trial Coordinator (Los Angeles, CA)
Age: 32 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- The DEPICT Act will definitely ensure more representation in trials, which has been lacking.
- It provides a framework that encourages inclusivity, which benefits everyone, not just minorities.
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 | 8 | 5 |
Patient in Cancer Clinical Trial (Houston, TX)
Age: 45 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Having a plan for diversity might increase the safety of treatments for people like me.
- I'm hopeful that the Act will allow for better treatment options that are tested on people like me.
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 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 4 |
Medical Device Developer (New York, NY)
Age: 28 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- The diversity plans may require more resources, but it'll likely improve overall device efficacy.
- Regulations might slow down development but should lead to more reliable devices in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Retired (Chicago, IL)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Ensuring diversity in trials is crucial for older adults like me who aren't always considered.
- The policy could mean newer, more effective treatments that account for age differences.
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 | 6 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Pharmaceutical Sales Representative (Atlanta, GA)
Age: 39 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- The DEPICT Act pushes for how sales teams market drugs, emphasizing diverse test results.
- It aligns with efforts to ensure drugs work well across demographics, which is crucial for cancer treatments.
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 |
University Student (Boston, MA)
Age: 22 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- The DEPICT Act is crucial for future research and equity in treatment efficacy.
- It provides a career pathway that integrates social justice with medical advancement.
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 | 10 | 8 |
Minority Health Advocate (Seattle, WA)
Age: 50 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy is necessary to address systemic biases in clinical trials.
- Representation means the world to those who have been overlooked for generations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Freelance Writer (Rural Kansas)
Age: 30 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- I hope the DEPICT Act helps improve healthcare access in rural areas by showing effectiveness across groups.
- This could reduce disparities but seems oriented towards urban issues.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Pharmaceutical Researcher (Miami, FL)
Age: 36 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- The policy could slow down research due to increased regulatory requirements.
- However, it also promises more comprehensive data for safer drugs.
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 | 8 |
| Year 20 | 8 | 7 |
Clinical Trial Participant (Denver, CO)
Age: 47 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I see the DEPICT Act as a step forward for patient rights and advocacy.
- It gives a voice to patients whose conditions were previously understudied.
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 | 8 | 5 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $15000000 (Low: $12000000, High: $20000000)
Year 2: $12000000 (Low: $10000000, High: $15000000)
Year 3: $10000000 (Low: $8000000, High: $12000000)
Year 5: $8000000 (Low: $6000000, High: $10000000)
Year 10: $5000000 (Low: $3000000, High: $8000000)
Year 100: $3000000 (Low: $1000000, High: $5000000)
Key Considerations
- The implementation of this act will increase upfront costs due to regulatory updates and compliance requirements for trial sponsors.
- Long-term potential savings arise from reduced inefficiencies and improved predictive power of clinical trials leading to safer and more effective drugs and devices.
- The policy's indirect economic benefits could outweigh immediate costs if implemented effectively, although such benefits might be realized over decades.