FDA issues two draft guidances for providing drug safety information for pregnant and lactating women
The Food & Drug Administration says healthcare professionals and patients sometimes struggle to determine if certain drugs and biological products are safe to use during pregnancy and breastfeeding due to a dearth of reliable medical studies – mainly because of ethical challenges regarding maternal and fetal safety.
“Because of the challenges in studying this area, often, women and their healthcare professionals must make decisions about whether to use a drug during pregnancy or lactation even when relevant safety data are scant or lacking,” they said.
This was the subject of a joint statement from FDA’s Principal Deputy Commissioner Amy Abernethy, and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. The agency also released 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.
FDA said the first draft guidance, Clinical Lactation Studies: Considerations for Study Design, will, when finalized, provide recommendations for sponsors conducting clinical lactation studies.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.
The draft guidance builds upon the agency’s previous guidance from 2005 (“Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling”) and streamlines and simplifies its recommendations for sponsors on these types of studies.
For example, FDA is 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 In addition, the draft guidance provides information about ethical considerations for when lactating women can potentially participate in a clinical trial.
FDA said it had discussions at advisory committee meetings and public workshops to consider how data from the studies can inform the safety of a drug when used during lactation, including whether it’s passed through breastmilk to a nursing infant, or if 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.
The second draft guidance, Postapproval Pregnancy Safety Studies which, when finalized, outlines FDA 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.
FDA says 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.
These recommendations, says the agency, also 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 FDA’s 2002 guidance, Establishing Pregnancy Exposure Registries.
