Bill Overview
Title: Advancing Safe Medications for Moms and Babies Act of 2022
Description: 2022 This bill establishes programs and requirements to support the inclusion of pregnant and lactating women in clinical research. For example, the bill requires the Department of Health and Human Services to align the Food and Drug Administration's regulations for human subjects in clinical trials with other departmental regulations for pregnant women in clinical research. The bill also establishes (1) a national online clearinghouse with information about clinical trials that enroll pregnant and lactating women, (2) an advisory committee to help coordinate federal activities with respect to clinical research for pregnant and lactating women, and (3) an educational campaign on the importance of including pregnant and lactating women in clinical research. The National Institutes of Health must also prioritize certain research projects on new and existing medications for pregnant and lactating women based on need, feasibility, and the potential impact of the research.
Sponsors: Rep. Castor, Kathy [D-FL-14]
Target Audience
Population: Pregnant and lactating women globally
Estimated Size: 7500000
- The global population size for pregnant women can be estimated given the global yearly birth rate of approximately 130 million babies, assuming similar numbers of pregnancies.
- The bill specifically focuses on pregnant and lactating women's involvement in clinical research, which is essential for creating safer pharmaceuticals for these groups.
- Given that many lactating women are also pregnant or were recently pregnant, there is a significant overlap in these groups.
- Promoting the inclusion of pregnant and lactating women in clinical trials has far-reaching implications worldwide as pharmaceuticals are globally distributed.
- Many countries follow the FDA's guidelines or consider them influential, hence the impact of this legislation could extend globally.
Reasoning
- Focusing on pregnant and lactating women, the policy will primarily impact those populations.
- Not all individuals will see direct impacts; there's a need for increased participation and educational awareness.
- Healthcare professionals such as obstetricians and researchers will also be indirectly impacted.
- Average citizens without a direct connection to the target groups will likely experience low to no impact.
- The interdisciplinary nature of this policy integrates healthcare, research, and public health education.
Simulated Interviews
Software Engineer (New York, NY)
Age: 30 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I felt excluded from some trials when I was pregnant, which was frustrating.
- The new policy seems beneficial as it prioritizes my current health needs.
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 | 6 |
| Year 20 | 8 | 5 |
Obstetrician (Austin, TX)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- I have always advocated for more inclusion of pregnant women in trials, this is a step in the right direction.
- It's great to have a national clearinghouse and advisory committee.
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 | 8 | 7 |
| Year 20 | 7 | 7 |
Pharmaceutical Researcher (Chicago, IL)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy will likely enhance the scope and safety of our trials involving pregnant women.
- The advisory committee could provide useful insights.
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 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 7 | 7 |
Stay-at-home mom (Portland, OR)
Age: 27 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- I find it hard to get information about drug safety in pregnancy.
- This policy's educational campaign seems very promising.
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 | 4 |
Public Health Advocate (Miami, FL)
Age: 33 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- This is a crucial policy for public health advancement.
- The educational aspects can bridge many gaps in health literacy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 5 |
Elementary School Teacher (Denver, CO)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- I'm generally supportive of health initiatives, though I don't see how this directly affects me.
- Awareness campaigns might be insightful.
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 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
PhD Student in Maternal-Fetal Medicine (San Francisco, CA)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Much needed awareness and resources for pregnant populations.
- This policy aligns with my research interests, potentially improving my academic environment.
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 | 7 |
Health Journalist (Los Angeles, CA)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- It's essential to bring light to the needs of pregnant women in clinical trials.
- This is a potential goldmine for news stories on public health.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Rural Family Doctor (Rural Indiana)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- Limited direct benefits, but useful for educating patients.
- Helps in addressing questions related to medication safety for my patients.
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 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Retired Nurse (Phoenix, AZ)
Age: 52 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- Finally addressing a long-standing gap in clinical trial representation.
- Hopeful for better outcomes for future generations.
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 | 8 | 7 |
| Year 20 | 7 | 7 |
Cost Estimates
Year 1: $50000000 (Low: $40000000, High: $60000000)
Year 2: $35000000 (Low: $30000000, High: $40000000)
Year 3: $35000000 (Low: $30000000, High: $40000000)
Year 5: $35000000 (Low: $30000000, High: $40000000)
Year 10: $35000000 (Low: $30000000, High: $40000000)
Year 100: $35000000 (Low: $30000000, High: $40000000)
Key Considerations
- Setting up and maintaining the online clearinghouse with accurate, up-to-date information.
- Coordination and roles of the advisory committee within federal research activities.
- Effectiveness and reach of the educational campaign to enlighten stakeholders about the importance of including pregnant and lactating women in trials.