FDA Supports Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

Officials at the FDA have announced their commitment to work with other regulators and industry to support the inclusion of pregnant and lactating women in clinical research worldwide.

The COVID-19 pandemic has put a spotlight on the lack of research data involving pregnant and breastfeeding women who, despite being at higher risk of severe illness and hospitalization from COVID-19 infection, are less likely to be included in clinical trials for medications or vaccines. Historically, concerns about potential harm to the unborn child have prevented pregnant and lactating individuals from participating in pre-approval clinical trials – leaving gaps in the information women and their doctors use to make important decisions about health care.

“Developing a roadmap for change, through international cooperation and harmonization, will take much care, consideration, and communication between all stakeholders,” wrote FDA officials. “Despite persistent challenges, there is strong interest from the international regulatory community to continue the momentum in this important area of women’s health.”

In 2014, the FDA issued the Pregnancy and Lactation Labeling Rule requiring manufacturers to update drug labels with any information relevant to pregnant or breastfeeding women, but did not require this information to be collected through clinical studies. In 2020, the agency was also part of the Task Force on Research Specific to Pregnant and Lactating Women, established by the 21st Century Cures Act, which established a plan calling for industry to modify trial designs to better accommodate pregnant and breastfeeding women.

Sources: RAPS.org, July 21, 2021; FDA.gov, July 19, 2021.