July 11, 2019

SWHR Submits Comments to FDA on Pregnancy and Lactation Draft Guidance

By Megan Ritchey, SWHR Communications Intern

Earlier this week, the Society for Women’s Health Research (SWHR) submitted comment letters to the Food and Drug Administration (FDA) in response to the agency’s draft guidance to industry on considerations for post-approval pregnancy safety studies and pre- and post-marketing lactation studies.

Millions of women become pregnant and give birth each year in the United States and a majority of those women will also breastfeed after delivery. Furthermore, almost 94% of pregnant women and more than 50% of lactating women take one or more medications.

Despite these significant numbers, there is a dearth of clinical research about drug safety and efficacy in pregnant and breastfeeding women. Consequently, these women and their health care providers do not have the information they need to make knowledgeable, confident decisions about medication use. Without reliable information, women who are pregnant or breastfeeding may decide to stop or not to start medications, even though this may not be the best health option. In addition, women may decide not to breastfeed or to stop breastfeeding if they need a medication but are unsure how it might affect their infant.

SWHR strongly supports the appropriate inclusion of pregnant and lactating women in clinical research in order to expand our knowledge of the safety and efficacy of drugs for these women and give them access to the information they need to make healthy decisions.

Read SWHR’s comment letters on the pregnancy and lactation studies guidance, outlining SWHR’s support of the FDA’s efforts to improve clinical studies for pregnant and lactating women as well as SWHR’s recommendations regarding each guidance.