Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide

<jats:title>Abstract</jats:title> <jats:p>In the 1960s, Dr. Frances Oldham Kelsey of the US Food and Drug Administration (FDA) became one of the most celebrated women in America when she prevented a deadly sedative from entering the US market. A Canadian-born pharmacologist and physician, Kelsey saved countless Americans from the devastating side effects of thalidomide, a drug routinely given to pregnant women to prevent morning sickness. As a result of Kelsey’s efforts, thalidomide was never sold in the United States. The incident led Congress to pass the 1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act, which fundamentally changed drug regulation in America. One of a small minority of women to earn an advanced degree in science in the 1930s, Kelsey faced challenges that resonate with women scientists to this day. Revered by the public as a “good mother of science,” she went on to act as a formidable gatekeeper against other suspect drugs, such as diethylstilbestrol (DES) and laetrile. Based upon FDA archival records, private family papers, and interviews with family and colleagues, this biography brings to light the efforts and legacy of a pioneering woman of science whose contributions remain influential.</jats:p>