The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.

George Herbert Hitchings researched and developed medications that targeted specific parts of DNA replication processes to treat cancers and various illnesses in the US during the twentieth century. By studying DNA analogs, or manmade substances that resemble the structure of naturally occurring DNA components and are capable of inhibiting DNA replication, Hitchings promoted a novel approach to pharmaceutical research and drug development, known as rational drug design. Using that novel approach, Hitchings and his research team created acyclovir, one of the first medications to effectively treat herpes, a condition that can be sexually transmitted but can also be passed from mother to child, causing life-threatening illness in infants. Hitchings also contributed to the development of cancer treatments, immunosuppressant medications, anti-viral medications, and anti-malarial medications. Hitchings’s research on DNA analogs established rational drug design as a method to create new pharmaceutical drugs, some of which treat sexually transmitted illnesses.