While Congress and the Administration had several priorities toward the end of the 117th Congress, including passing an end-of-year spending package for fiscal year 2023, the Coalition to Advance Maternal Therapeutics (CAMT) was successful in its efforts to help drive policy toward greater inclusion of pregnant and lactating populations in research.
Fiscal Year 2023 Omnibus
Within the Consolidated Appropriations Act, 2023 (H.R. 2617), which was signed into law by President Biden on December 29, 2022, there were several provisions that would support the inclusion of pregnant and lactating people in clinical trials.
Among the spending package’s health care provisions, the Office of Women’s Health in the Office of the U.S. Department of Health and Human Services (HHS) Secretary received $200,000 to establish an Advisory Committee to monitor the implementation of recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), a Task Force established to advice the HHS Secretary about gaps in knowledge and research on safe and effective therapies for pregnant and lactating women.
With respect to the U.S. Food and Drug Administration (FDA), there was report language accompanying the bill requiring the FDA to work toward consensus standards for pregnancy and lactation registries. Additionally, the bill included language that would require new drug or device sponsors to submit a diversity action plan to the FDA for Phase 3 studies. Pregnant and lactating people are included in the list of populations for sponsors to consider when developing enrollment goals for those diversity plans.
Advancing Safe Medications for Moms and Babies Act
Another achievement for this area in 2022 was the introduction of H.R. 9487, the Advancing Safe Medications for Moms and Babies Act of 2022. The bill, introduced by Representatives Castor (FL-14), Fitzpatrick (PA-01), and Underwood (IL-14) in December 2022, is a follow up to the Safe Medications for Moms and Babies Act of 2016, which became law as part of the 21st Century Cures Act in 2016. The 2016 legislation established PRGLAC to advance research and information on medication use during pregnancy and breastfeeding. The new legislation would build upon that legislation to better our understanding of the effect of medications on pregnant and lactating women and their infants. Rep. Castor, in the legislation’s press release, spoke to the importance of the bill:
“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 effects of medications used during pregnancy to ensure the best health outcomes for themselves and their babies.”
Rep. Kathy Castor (FL-14), Rep. Castor Introduces Bipartisan Legislation to Promote the Inclusion of Pregnant and Lactating Women in Clinical Research, 12/13/2022
The Advancing Safe Medications for Moms and Babies Act will likely be reintroduced for the 118th Congress at the end of February. If your national organization would like to endorse the legislation, please complete this Google Form.
For questions, please contact Lindsey Horan.
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