USA – Studying Drugs in Pregnant and Nursing Women: FDA Issues Draft Guidances

In an effort to improve the availability of data on the effects of prescription drugs in pregnant and lactating women, the US Food and Drug Administration (FDA) on Wednesday issued two draft guidances detailing recommendations for conducting clinical lactation studies and postapproval pregnancy safety studies.

“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,” said FDA Principal Deputy Commissioner Amy Abernethy and Center for Drug Evaluation and Research Director Janet Woodcock.

This lack of data often leads physicians and women to make decisions about prescription drugs without knowing if there are increased maternal and fetal safety risks or risks of drug exposure to nursing infants.

The first guidance, Clinical Lactation Studies: Considerations for Study Design, discusses the design, conduct and ethical considerations for clinical lactation studies, which are required under certain circumstances. The guidance replaces the agency’s 2005 draft guidance, Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling.

The second draft, Postapproval Pregnancy Safety Studies, provides recommendations on the design of postapproval studies to assess the effects of drugs in pregnant women and includes considerations for leveraging real-world data such as insurance claims and electronic health records. FDA says the guidance will replace 2002 guidance, Establishing Pregnancy Exposure Registries, once finalized.

Both guidances incorporate input FDA received during public workshops and are aligned with recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)…