PRGLAC Then and Now: Where We Are and Where We’re Going

The 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of the U.S. Department of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The Task Force’s work culminated in a set of recommendations based on information gleaned during four open meetings and a public comment period. The central theme of those recommendations was “the need to alter cultural assumptions that have significantly limited scientific knowledge of therapeutic product safety, effectiveness, and dosing for pregnant and lactating women.”

During this congressional briefing and national webinar, designed specifically for—but not limited to—members of the 118th Congress, panelists reviewed the state of PRGLAC, the PRGLAC recommendations and their implementation status, the current legislative and regulatory landscape, and reviewed actions that can be taken at the federal level to increase representation of these populations in clinical trials.

Panelists

• Diana Bianchi, MD, Director, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
• Jennita Reefhuis, PhD, Branch Chief, Birth Defects Monitoring and Research Branch, Centers for Disease Control and Prevention Division of Birth Defects and Infant Disorders
• Kaveeta Vasisht, MD, PharmD, Associate Commissioner for Women’s Health, U.S. Food and Drug Administration

This event is part of a series about the inclusion of pregnant and lactating peoples in research hosted by the Coalition. The full series includes:

• Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6, 2022)
• Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26, 2023)
• PRGLAC Then and Now: Where We Are and Where We’re Going (February 14, 2023)