In 1970, the U.S. Food and Drug Administration (FDA) required the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.

Before this, patients primarily relied on information from their doctors or pharmacists. This was one of the first times the FDA empowered patients directly by mandating that important information about their prescribed medications be provided along with the medication itself.

Patient package inserts, as such, meant that the customers taking the drug directly were made aware of the potential side effects, health risks, and other information about the medicine. With the birth control pill’s surging popularity during this period and evidence that women were not fully told the potential side effects of the contraceptive, the FDA announced that they would require the pill’s manufacturers to place the insert in every package of pills.

This insert, written by the FDA to be understandable by every layperson, allowed women to make informed choices about whether they wanted to take the drug. A series of controversies followed this requirement, both against (from the medical and pharmaceutical industries) and for (from feminist groups) the insert.

Ultimately, the FDA decided to compromise on a shorter package insert, which gave a brief overview of the pill’s major health risks and advised women who wanted more information about the pill to ask their doctor for a longer and more comprehensive booklet written by the American Medical Association, the FDA, and the American College of Obstetricians and Gynecologists.