Rep. Castor Reintroduces Bipartisan Legislation to Promote the Inclusion of Pregnant and Lactating Women in Clinical Research

This week, Representatives Kathy Castor (FL14), Brian Fitzpatrick (PA01), and Lauren Underwood (IL14) reintroduced H.R. 1117, the Advancing Safe Medications for Moms and Babies Act of 2023. This bipartisan bill would build upon prior legislation to better our understanding of the effect of medications on pregnant and lactating women and their infants. By updating FDA regulations, establishing a national clearinghouse of educational materials, creating a coordinating committee of federal activities, and raising awareness for patients and providers, this legislation would help ensure that moms and babies stay safe and healthy.

A section-by-section is available here.

"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 whilebreastfeeding," said Castor. "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. The presumption that the use of medications throughout pregnancy and lactation is unsafe is inaccurate in many cases, and may actually endanger the health of moms and babies. I thank Representatives Fitzpatrick and Underwood for joining me in leading the effort to promote the inclusion of pregnant and lactating women in clinical research through our Advancing Safe Medications for Moms and Babies Act."

"It is vital that we continue to advance medications and treatments for pregnant and lactating women to keep them healthy," said Fitzpatrick. "I am proud to work alongside Representatives Castor and Underwood to push for updated FDA regulations, continued educational materials, and overall awareness of how medications impact pregnant and lactating women."

"Pregnant and lactating people must be protected through research, not excluded from it," said Underwood. "The exclusion of this population from clinical trials for COVID-19 vaccines led to a serious information gap that resulted in lower vaccination rates for pregnant people. Evidence now shows that COVID-19 vaccines are safe and effective for people who are pregnant or trying to become pregnant. We must do more to protect this population, and the Advancing Safe Medications for Moms and Babies Act takes important steps to ensure that pregnant and lactating people can safely access life-saving vaccines and therapeutics."

"Despite the fact that 90% of pregnant individuals take at least one medication during pregnancy, they were excluded from 70% of clinical trials last year," said Iffath Abbasi Hoskins, MD, president of the American College of Obstetricians and Gynecologists (ACOG). "To their detriment, pregnant and lactating individuals have been historically excluded from clinical trials, preventing us from gathering the critical data needed regarding the effects of most medications and therapeutics during pregnancy and lactation. ACOG applauds the leadership of Representatives Kathy Castor, Brian Fitzpatrick, and Lauren Underwood in introducing the Advancing Safe Medications for Moms and Babies Act, legislation that will help ensure that pregnant and lactating individuals are no longer put at a disadvantage and without the necessary information to make informed, evidence-based decisions about their health."

"Nearly all pregnant and lactating people rely on some type of medication, vaccine, or medical device; yet, these populations are systematically excluded from most clinical trials, leaving patients and clinicians with little evidence to guide treatment decisions," said Rebecca Abbott, Senior Director of Advocacy for the Society for Maternal-Fetal Medicine (SMFM). "Maternal-fetal medicine subspecialists and their patients are uniquely impacted by the dearth of data, as high-risk pregnant patients often enter pregnancy with health conditions or develop conditions during pregnancy that require treatment with medications. They are left will little or no data on the safety and efficacy of therapeutics during a critical period for both mother and baby. As such, SMFM thanks Representatives Castor, Fitzpatrick, and Underwood for introducing the Advancing Safe Medications for Moms and Babies Act of 2023 and leading efforts in the US House of Representatives to ensure pregnant and lactating people are included in clinical research."

"The Society for Women's Health Research is grateful to Representatives Castor, Fitzpatrick, and Underwood for introducing this critically needed legislation. We owe it to women everywhere to have the greatest understanding possible of the safety and efficacy of treatments used during pregnancy and lactation. Ensuring pregnant and lactating populations are included will clinical trials will lay that necessary foundation and equip us with evidence that can help improve outcomes for them and their babies."

"As the nation's leader on maternal and infant health policy, March of Dimes strongly supports the Advancing Safe Medications for Moms and Babies Act of 2022. Our organization is devoted to working to raise awareness about research gaps in therapeutics for pregnant and lactating individuals, and the need to include them in clinical trial studies. This legislation will take important steps to better our understanding of the effect of medications on pregnant and breastfeeding individuals and their infants. We applaud Rep. Kathy Castor, Rep. Brian Fitzpatrick, and Rep. Lauren Underwood for their leadership," said Stacey Y. Brayboy, Senior Vice President, Public Policy and Government Affairs.

This legislation is a follow-up to the Safe Medications for Moms and Babies Act of 2016, sponsored by Rep. Castor and Rep. Jaime Herrera-Beutler, which became law as part of the 21st Century Cures Act in 2016. It established a Task Force of federal and medical experts to advance research and information on medication use during pregnancy and breastfeeding.

The bill is supported by the following organizations: 2020 Mom, American Academy of Pediatrics, American Academy of Allergy, Asthma, and Immunology, and Immunology, Association of Maternal & Child Health Programs, American College of Nurse-Midwives, Children's Hospital Association, Elizabeth Glaser Pediatric AIDS Foundation, Endocrine Society, Epilepsy Foundation, March of Dimes, Maternal Mental Health Leadership Alliance, National Association of Nurse Practitioners in Women's Health, Organization of Teratology Information Specialists, Society for Birth Defects Research and Prevention, Society for Maternal-Fetal Medicine, Society for Women's Health Research, Treatment Action Group, TSC Alliance, UCB, WomenHeart.