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 The guidance replaces the agency’s 2005 draft guidance, Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling.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).
Clinical lactation studies
FDA says its new draft guidance on clinical lactation studies “streamlines and simplifies” its recommendations for conducting such studies.
In the guidance, FDA says drugmakers should conduct clinical lactation studies “when a drug is expected too 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.”
The guidance also provides ethical considerations for enrolling lactating women in clinical lactation studies, such as when a woman is already taking the drug being studied as part of her standard clinical care.
“If a lactating woman was prescribed and is continuing to take a medically necessary drug, it is not necessary to stop the drug for the purposes of enrollment in a research setting. It would be ethically acceptable to enroll women who have already made a decision to take a medically necessary drug while breastfeeding and allow them to continue breastfeeding while taking the drug,” FDA writes.
In this case, FDA says the risk of drug exposure to the infant would be considered “a clinical risk” and that any risks pertaining to the research must be described.
For breastfeeding women that are administered investigational drugs as part of clinical studies, the guidance lays out considerations for whether breastfeeding should be discontinued throughout the study or whether participants should temporarily pump and discard milk.
In the case of healthy volunteers who are breastfeeding and participating in clinical lactation studies, FDA says breastfeeding must be discontinued for the duration of the study.
Postapproval Pregnancy Safety Studies
In the guidance on postapproval pregnancy safety studies, FDA lays out recommendations for designing and conducting postapproval studies using pregnancy registries, pharmacovigilance data, and other data sources such as electronic data sources and population-based surveillance sources.
“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 data,” Abernethy and Woodcock said.
According to the guidance, these additional data sources “may help address the limitations inherent to a pregnancy registry.”
Clinical Lactation Studies: Considerations for Study Design, Federal Register Notice
Postapproval Pregnancy Safety Studies, Federal Register Notice
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