Guardian of Safety: Dr. Frances Kelsey’s Stand Against Thalidomide

Abstract

This case study explores the thalidomide tragedy of the late 1950s and early 1960s in the United States, which had far-reaching consequences for public health and perinatal care. The case examines the role of Dr. Frances Oldham Kelsey, a feminist leader and newly appointed medical officer at the US Food and Drug Administration (FDA), in the tragedy and her unwavering commitment as a public health officer. Kelsey’s entrance into this government agency led her to an immediate and dramatic crossroads: would she approve a promising treatment based on foreign safety data alone, or demand more evidence despite delaying potential relief? Through historical and public health-based research, including first-hand testimony, this case explores the importance of feminist leadership, diligence, and trust in scientific judgment when establishing and safeguarding effective public health practices.