Thalidomide drug restrictions, 1960s. Named here under the trademark 'Kevadon', thalidomide was a sleeping pill that had been restricted in the USA for use only in research. Thousands of reports from western Europe in 1961 linked the use of this drug by pregnant women to birth defects. The previous year in 1960, Canadian-US pharmacologist and physician Frances Kelsey, working for the US Food and Drug Administration (FDA), had denied the 1960 application for approval of thalidomide. Her decision was based on a lack of evidence to establish its safety, despite considerable lobbying by the manufacturer. The response to her action led to the passage of laws that created a standard that drugs should be shown to be effective and safe prior to marketing.