FDA proposes including pregnant, lactating women in clinical trials

Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and lactating women, the Food and Drug Administration (FDA) is calling for a paradigm shift in how medical products are studied in these populations. Historically, pregnant and lactating women have been excluded from clinical trials, primarily due to concern about the potential risk to the fetus or child. For example, no pregnant women were enrolled in clinical trials of the drug remdesivir or prelicensure COVID-19 vaccine trials. A recent article in FDA Voices described the agency’s past steps to address this information gap, beginning with 2014’s Pregnancy and Lactation Labeling Rule. The agency plans future initiatives, including collaborations with its European and British counterparts, which are also working to foster clinical trial innovations that meet the needs of pregnant women and other neglected populations. (FDA Voices article, 7/19/21)