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.

In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States. Section 3509, titled “Improving Women’s Health,” established the Office on Women’s Health within the US Department of Health and Human Services and in four of its agencies, the Agency for Healthcare Research and Quality, the Center for Disease Control and Prevention, the Food and Drug Administration, and the Health Resources and Services Administration. Section 3509 of the ACA exemplified a federal effort to improve women’s health in the US by increasing the amount of research and programs focused on the health concerns of American women.