December 13, 2022

Reps. Castor, Fitzpatrick, and Underwood Introduce Legislation to Promote Greater Inclusion of Pregnant and Lactating Women in Research

This blog post was originally published by the Coalition to Advance Maternal Therapeutics. The Society for Women’s Health Research, a member of the Coalition, has endorsed the following legislation.

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:

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: