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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.
In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity.
Title 1, Subtitle B, Parts I, II, and III of the “National Institutes of Health Revitalization Act of 1993” (1993)
In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm.
In the 1973 court case Doe v. Bolton, the US Supreme Court in Washington, D.C., ruled that a Georgia law regulating abortion was unconstitutional. The Georgia abortion law required women seeking abortions to get approval for the procedure from their personal physician, two consulting physicians, and from a committee at the admitting hospital. Furthermore, under the statutes, only women who had been raped, whose lives were in danger from the pregnancy, or who were carrying fetuses likely to be seriously, permanently malformed were permitted to receive abortions.