Castor, Fitzpatrick, Underwood Reintroduce Bipartisan Legislation to Promote the Inclusion of Pregnant and Lactating Women in Clinical Research

TAMPA, Fla. - Ahead of Mother's Day, Representatives Kathy Castor (FL-14), Brian Fitzpatrick (PA-01), and Lauren Underwood (IL-14) reintroduced H.R. 8651, the Advancing Safe Medications for Moms and Babies Act. The bipartisan legislation builds on earlier congressional efforts to strengthen and deepen the understanding of how medications affect pregnant and lactating women and their infants. It would modernize FDA regulations, raise awareness of research that includes pregnant and lactating women, and encourage high-quality priority research projects to be conducted at the NIH-to help ensure moms and babies stay safe and healthy.

"Excluding pregnant and lactating women from research and trials creates significant information gaps that can impact the health of mothers and babies," said Rep. Castor. "We can and must do better. Expectant mothers and their doctors deserve clear, accurate guidance about how medications affect both mom and baby so they can make informed decisions and achieve the best possible health outcomes. Too often, a blanket assumption that medications are unsafe during pregnancy or breastfeeding is simply wrong-and in some cases, it can put moms and babies at greater health risk of costly complications. I'm grateful to my colleagues, Representatives Brian Fitzpatrick and Lauren Underwood, for their partnership in advancing this bipartisan effort to expand high-quality scientific research and improve health outcomes through the 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 Rep. 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 Rep. 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."

"The American College of Obstetricians and Gynecologists (ACOG) has long advocated for the inclusion of pregnant people in clinical trials to help ensure the safety and efficacy of medication taken during pregnancy. Ninety percent of pregnant individuals take at least one medication during pregnancy, and yet seventy percent of medications approved by the FDA have no human pregnancy data. Not only does this present challenges for clinicians who have to manage the treatment of chronic conditions during pregnancy, but it creates uncertainty for patients when there is a lack of critical data on the effects of medications and therapeutics taken during pregnancy and lactation," said ACOG President Camille A. Clare, MD, MPH, CPE, FACOG. "By taking steps to ensure pregnant and lactating women are included in clinical trials, the Advancing Safe Medications for Moms and Babies Act will help give our patients and their physicians peace of mind when taking needed medications during pregnancy and lactation. We applaud the continued leadership of Representatives Kathy Castor, Brian Fitzpatrick, and Lauren Underwood for introducing this legislation and ensuring that this issue remains at the forefront."

"As the nation's leading nonprofit fighting for the health of all moms and babies, March of Dimes strongly supports the Advancing Safe Medications for Moms and Babies Act of 2026. Despite the prevalence of pregnancy complications, pregnant and lactating individuals are often excluded from clinical trials for the therapeutics they depend on. This legislation takes important steps to better our understanding for those who are pregnant or breastfeeding of how to take medications and vaccines safely and effectively. We applaud Representatives Kathy Castor, Brian Fitzpatrick, and Lauren Underwood for their continued leadership," said Stacey Y. Brayboy, Senior Vice President, Public Policy and Government Affairs, March of Dimes.

"The Society for Women's Health Research (SWHR) is pleased to see the reintroduction of the Advancing Safe Medications for Moms and Babies Act. By advancing the inclusion of pregnant and lactating populations in clinical research, this legislation will drive safer, evidence-based treatments and healthier outcomes for moms and babies alike. SWHR thanks Representatives Castor, Fitzpatrick, and Underwood for introducing this important legislation and their continued leadership in this space," said Kathryn Schubert, President and CEO, Society for Women's Health Research.

"Inclusive clinical research isn't just good science; it's essential for the health of pregnant and lactating individuals. As the CEO of HealthyWomen and a practicing maternal and fetal nurse, I have seen firsthand how critical it is to equip expectant and new mothers with accurate, evidence-based information on how to best care for themselves and their babies, including medication use and vaccine uptake. But too often, this information is unavailable, sparse or delayed, leaving pregnant and lactating individuals uncertain during a vulnerable time. That's why we are proud to support this bill that takes a crucial step toward ensuring that clinical trials and research are inclusive and accessible to pregnant and lactating individuals," said Beth Battaglino, RN-C, CEO of HealthyWomen.

"Including pregnant women in research is not a risk to be avoided-but an opportunity to embrace. For the first time in decades, researchers have begun to learn how to identify and prevent preeclampsia with new therapies on the horizon. However, the therapeutic pipeline only reaches patients if pregnant women are included in clinical research, and the federal investment is there to support it. The Advancing Safe Medications for Moms and Babies Act delivers both. We thank Representatives Castor, Fitzpatrick, and Underwood for their leadership and urge Congress to pass this bill without delay," said Eleni Tsigas, CEO, Preeclampsia Foundation.

The bill is supported by the following organizations: Academy of Breastfeeding Medicine (ABM); American Academy of Pediatrics; American College of Obstetricians and Gynecologists (ACOG); Association of Maternal & Child Health Programs (AMCHP); HealthyWomen; Lupus Foundation of America; March of Dimes; Maternal Mental Health Leadership Alliance; Preeclampsia Foundation; Society for Birth Defects Research and Prevention; Society for Maternal-Fetal Medicine; Society for Women's Health Research (SWHR); U.S. Breastfeeding Committee; VAMPSS (Vaccines and Medications in Pregnancy Safety Studies) / American Academy of Allergy, Asthma & Immunology; Wake Up Narcolepsy, Inc.; WomenHeart: The National Coalition for Women with Heart Disease.