Many pregnant women need to take medicines. For some it may be to manage a chronic health condition like asthma, epilepsy or hypertension. For others it may be to treat a new condition, which may start to get worse because of pregnancy. While most FDA approved medical products have not been studied for use in pregnancy—stopping or not taking these products may carry serious risks.
FDA is actively working to advance knowledge of the safety and efficacy of medical products used by pregnant women. The FDA Office of Women’s Health (OWH) leads pregnancy research initiatives and works closely with FDA’s Centers to support policy, research and other initiatives to help increase available safety information on FDA-regulated products during pregnancy. OWH also remains at the forefront of FDA efforts to address emerging issues related to pregnancy, like the Zika virus outbreak. This webpage highlights the multi-prong approach used by the FDA Office of Women’s Health to enhance health for mothers and their children.
- OWH-Funded Research
- Pregnancy Exposure Registries Initiative
- New Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
- FDA Policy and Guidance
- Consumer Education and Outreach
The FDA Office of Women’s Health awards research grants to support FDA regulatory decision-making and advance the science of women’s health. OWH has funded research projects and collaborated with other FDA centers to address health issues affecting pregnant women.
Pregnancy exposure registries are important tools used to gather data on the effects of medical product exposures on the health of a pregnant woman and her fetus. The FDA Office of Women’s Health created a web portal and collaborates with public and private partners to conduct outreach to connect pregnant women and health professionals with over 35 medical product and disease based registries that collect information on drug exposures during pregnancy.
The 21 Century Cures Act established the PRGLAC Task Force, led by the National Institutes of Health (NIH), to advise the Secretary of HHS regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The FDA Office of Women’s Health leads the FDA committee.
OWH works to ensure that the science of women’s health and perspectives on the analysis of sex-based differences are integrated into FDA policies and guidance supporting regulatory review of medical products.
OWH hosts workshops to disseminate the findings of funded pregnancy research and collaborates with the FDA Centers on public meetings to foster scientific dialogue on methods to collect data on medical product exposures during pregnancy.
- 2014 Public Meeting: Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products during Pregnancy in the Post-Approval Setting.
- 2011 Pregnancy and Prescription Medication Use Symposium - Increased awareness regarding the use of prescription medications used during pregnancy and the need for ongoing studies to improve pregnancy labeling.
Pregnancy and Lactation Labeling Final Rule
On December 3, 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).
The final rule applies to biological products subject to the Physician Labeling Rule. This rule also applies to products regulated by the Center for Biologics Evaluation and Research, including, but not limited to: vaccines, allergenics and cellular and gene therapies.
FDA Guidance Related to Pregnancy Research
Health Resources for You and Your Baby Initiative
This initiative disseminates plain language fact sheets, videos, and social media resources on medication use during pregnancy. It also utilizes the FDA Pregnancy webpage to raise awareness about medication and other product safety information related to pregnancy and lactation.