Several methods of contraception, or birth control, are currently available. Prior to the avail­ability of any contraceptive method, the United States Food and Drug Administration (FDA) must formally approve the method. Let’s explore the FDA approval process and in­dividual lifestyle issues that may affect contraceptive method choice.

FDA Approval Process

The FDA is responsible for approving all prescription medications in the United States. To get approval, a pharmaceutical company must submit a new drug application (NDA) to the FDA showing that the drug is safe in animal tests and that it is reasonably safe to proceed with human trials of the drug.

There are a total of three phases to the approval process. In Phase 1, the drug is in­troduced to approximately 20 to 80 healthy volunteers to collect information on the drug’s effectiveness. In Phase 2, several hundred people with the medical disease or con­dition the drug will be treating are enrolled to evaluate how the drug works and deter­mine what the side effects and risks of the drug are (in clinical trials volunteers are of­ten given the drugs for free and perhaps even paid for their time). In Phase 3 trials, the study is expanded, hundreds to thousands of people are enrolled in the study, and infor­mation is collected to extrapolate to the general public. It is estimated that it takes 10 to 14 years to develop a new contraceptive drug (F. Stewart & Gabelnick, 2004). Throughout this process, animal trials are maintained to look at long-term side effects of the proposed drugs.