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FDA Statement

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women

For Immediate Release:
Statement From:
Amy Abernethy, MD, PhD.
Principal Deputy Commissioner - Office of the Commissioner

It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. Ethical challenges often arise in studying women in these populations as there are valid concerns about maternal and fetal safety. For example, if a woman who is currently breastfeeding starts an investigational drug for a disease or condition, breastfeeding should be discontinued for the duration of the study because the risks of the exposure to the drug in the breastfeeding infant may outweigh the benefits.

We also know that there are differences in how medicines affect men compared to women, and pregnancy can often add to these differences. But because of the challenges in studying this area, often, women and their health care professionals must make decisions about whether to use a drug during pregnancy or lactation even when relevant safety data are scant or lacking.

The FDA is committed to advancing and promoting women’s health and continues to engage in an open public dialogue with patient groups, medical experts and other federal partners to address the gap in scientific knowledge for women during this important phase of their lives. Today, we’re issuing two draft guidances, which, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information in drugs used during pregnancy or lactation.

The first draft guidance, Clinical Lactation Studies: Considerations for Study Design, will, when finalized, provide recommendations for sponsors conducting clinical lactation studies. The FDA has required these studies under the Food, Drug, and Cosmetic Act under some circumstances and is considering additional circumstances in which they may be recommended. Today’s draft guidance builds upon our previous guidance from 2005 (“Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling”) and streamlines and simplifies our recommendations for sponsors on these types of studies. The revised guidance, when finalized, will help to work toward overcoming the knowledge gap that health care professionals and women may face in making decisions about their health and the health of their baby. For example, we’re recommending when companies should conduct a lactation study when a drug is expected to be used in women of reproductive age, or if a new indication is being sought for an approved drug and there is evidence of use or anticipated use of the drug by women who are breastfeeding. In addition, the draft guidance provides information about ethical considerations for when lactating women can potentially participate in a clinical trial.

In developing this draft guidance, we factored in discussions at advisory committee meetings and public workshops where we considered how data from these studies can inform the safety of a drug when used during lactation, including whether it’s passed through breastmilk to a nursing infant, or there are any changes in a women’s body as a result of her lactation that could otherwise impact the safety or efficacy of a drug.

We’re also announcing a second draft guidance, Postapproval Pregnancy Safety Studies which, when finalized, will outline our recommendations on how to design studies and leverage other forms of data, including real-world data, to assess the outcomes of pregnancies in women taking to FDA-regulated drugs and biological products during pregnancy. 
The Postapproval Pregnancy Safety Studies draft guidance broadens the scope of methods used in collection of safety information for drugs and biological products used during pregnancy to include database studies such as claims or electronic health records, case-control studies, population-based surveillance and other pharmacovigilance methods. The recommendations in this draft guidance reflect discussions and recommendations received during a two-day workshop convened by the FDA in 2014, Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting, as well as FDA review. When finalized, this guidance replaces our 2002 guidance, Establishing Pregnancy Exposure Registries.

Both draft guidances announced today are consistent with the recommendations made by the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). The 21st Century Cures Act established this task force to identify and report on gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The task force includes representatives from federal agencies, including the FDA, the National Institutes of Health and the Centers for Disease Control and Prevention, among others. Non-federal members include representatives from industry and other relevant organizations.

The draft guidances are an additional step the agency is taking toward getting women who are pregnant or breastfeeding important safety information about their medications, so they can make informed decisions about their health and the health of their babies. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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