Today, Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) introduced H.R. 9487, the Advancing Safe Medications for Moms and Babies Act of 2022. The ultimate goal of the bipartisan legislation is “to better our understanding of the effect of medications on pregnant and lactating women and their infants.”
The Advancing Safe Medications for Moms and Babies Act builds on the work of the Safe Medications for Moms and Babies Act of 2016, which established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). PRGLAC was tasked with advising the U.S. Secretary of Health and Human Services (HHS) about gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. Its work culminated in a September 2018 Report to the HHS Secretary and Congress, which included a List of 15 Recommendations, and a Report Implementation Plan that was released in 2020 with steps that federal agencies, industry, and stakeholders should take to carry out the Task Force’s recommendations.
The new legislation from Reps. Castor, Fitzpatrick, and Underwood would put many of the implementation steps into action. As shared in the legislation summary document, steps outlined in the legislation include:
- Updating U.S. Food and Drug Administration (FDA) regulations to remove pregnant women as a vulnerable research population
- Establishing a national clearinghouse of educational materials and current information on registries and clinical trials that enroll pregnant and lactating women
- Creating a Committee on Research Specific to Pregnant and Lactating Women to coordinate federal activities to address gaps in knowledge and research regarding safe and effective therapies, promote inclusion in research, and develop annual summaries of progress toward implementing recommendations for pregnant and lactating women
- Raising awareness of clinical research that includes pregnant and lactating women through an educational campaign for the public, health care providers, and other stakeholders
- Directing the NIH to prioritize research on existing and new medications prescribed for pregnant and lactating women
As Rep. Castor states in the press release, “Pregnant and lactating women have very little information on the safety of therapeutics and vaccines in pregnancy, and even less on the safety for the baby while breastfeeding… We can do better. Expectant mothers and their doctors should have accurate information about the effects of medications used during pregnancy to ensure the best health outcomes for themselves and their babies.”
Read Rep. Castor’s press release on the bill introduction here, and find a section-by-section summary of the bill here.
Additional Resources and Links:
- Task Force on Research Specific to Pregnant Women and Lactating Women Web Page
- “Pregnant Women Must Be Included in Medical Research,” Scientific American
- Inclusion of Pregnant and Lactating Persons in Clinical Trials – A Workshop, National Academies of Sciences, Engineering, and Medicine
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