SWHR Comments on FDA Guidance on Pregnant Women in Clinical Trials

Policy Engagement

Published 8/8/18

SWHR submitted comments to the federal Food and Drug Administration (FDA) regarding FDA’s recently issued draft guidance on recommendations for the inclusion of pregnant women in clinical trials. Nearly 4 million women give birth on a yearly basis and almost all of these women take at least one prescription or over-the-counter medication during pregnancy. However, there remains a comparative lack of human data on drug safety and efficacy among pregnant and lactating women.

SWHR asked for clarification regarding whether these provisions will also apply to lactating women, a separate population that is nonetheless nearly equal in size. Estimates suggest that 3 million women breastfeed on an annual basis. Additionally, FDA’s list of 10 conditions necessary for pregnant women to be included in research is overly arduous. Specifically, the need for parental consent from the father or domestic partner of the woman places undue burden in cases where there is a prospect for direct benefit to the child.

Read SWHR’S Full Set Of Comments Here