New FDA Policies Seek To Improve Data On Drug Side Effects On Pregnant and Nursing Women

Federal regulators have proposed two new regulations, which they hope will improve clinical studies for medications that are used during pregnancy and lactation.

The proposed draft guidance was issued by the FDA on May 8, including the Clinical Lactation Studies: Considerations for Study Design draft guidance and the Post Approval Pregnancy Safety Studies draft guidance.

FDA officials say the guidance aims to broaden the scope of drug safety during pregnancy and breastfeeding, while still keeping safety to both mother and child a priority.

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Officials say the agency recognizes there are ethical challenges to consider when studying pregnant women or breastfeeding women. Concerns regarding maternal and fetal safety are the issues at the forefront of designing and conducting studies and recommending medications to this population of women.

Principal Deputy Commissioner Dr. Amy Abernethy, and Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, say that the two new draft guidance were created using a combination of discussions during advisory committee meetings and public workshops.

They said the agency is committed to advancing and promoting women’s health and addressing the gap in scientific knowledge concerning women during pregnancy and women while breastfeeding.

The first, the Clinical Lactation Studies: Considerations for Study Design guidance, focuses on recommendations for studies on clinical lactation. Additionally, the FDA is considering additional circumstances in which studies of clinical lactation may be recommended.

The guidance includes specific recommendations to conduct lactation studies when a drug will be used in women of reproductive age. The agency hopes this will help provide more complete information about whether drugs are passed through breast milk to the nursing infant, or if changes to a woman’s body from lactation can impact the safety of a drug.

The second guidance, Post Approval Pregnancy Safety Studies, outlines recommendations on how to design clinical studies during pregnancies. The guidance includes steps to help pregnant or breastfeeding women obtain information about the safety of the medications they take so they can make informed decisions for the health of the baby and their own health.

“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,” Woodcock and Abernethy wrote.


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