Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution. Due to thalidomide's effects on fetuses, both nationally and abroad, the US Congress passed the 1962 Kefauver-Harris Amendments to the 1938 Food, Drug, and Cosmetic Act. These amendments imposed guidelines for the process of drug approval in the US and required that a drug be safe as well as effective before it could be approved and marketed. Thalidomide also influenced the FDA's creation of pregnancy categories; a ranking of drugs based on their effects on reproduction and pregnancy. Thalidomide motivated the laws on regulating and monitoring drugs developed in the US and by the FDA in the twentieth and twenty-first centuries.

Thalidomide is a sedative drug introduced to European markets on 1 October 1957 after extensive testing on rodent embryos to ensure its safety. Early laboratory tests in rodent populations showed that pregnant rodents could safely use it, so doctors prescribed Thalidomide to treat morning sickness in pregnant women. However, in humans Thalidomide interfered with embryonic and fetal development in ways not observed in rodent tests. Pregnant women who take Thalidomide are at grater than normal risk for spontaneous abortion and for giving birth to children with developmental anomalies such as shortened, absent, or extra limbs, as well as a variety of heart, ear, and internal organ defects. The failure of rodent models to inform scientists of Thalidomide's teratogenicity in humans ignited debate about the proper use of cross-species testing during drug development.

Sherri Chessen, also known as Sherri Finkbine, a television host who lived in Scottsdale, Arizona, during the 1960s, sought an abortion after learning that the sedative thalidomide caused fetal deformities. At the time, Arizona law only allowed abortions if the mother’s life was at risk. Chessen anonymously contacted The Arizona Republic, a local newspaper, and a reporter, Julian DeVries, told Chessen’s story in an article titled, “Pill May Cost Woman Her Baby.” Chessen’s identity later became public when the Good Samaritan Hospital in Phoenix, Arizona, where Chessen was to have the abortion, filed a suit to get the state’s approval to authorize the abortion. After her name became public, the hospital refused to perform the abortion, leading Chessen to travel to Sweden for the procedure. Chessen’s case led to widespread discussion about abortion access in the United States, brought the issue of reproductive rights into the national spotlight, and eventually influenced legal reforms, including the US Supreme Court’s decision in Roe v. Wade (1973).