After several years of delays and a series of questionable actions by the Food and Drug Administration (FDA), on August 18, 2006 Plan B® emergency contraception (two .75mg levonorgestrel tablets) was finally granted over-the-counter (OTC) status for women 18 and older. Justification for an age restriction was based on concerns cited by top FDA officials regarding the limited amount of research done on the use of emergency contraception (EC) among young teens. Contrary to those concerns, other FDA staff, advisory committee members and outside experts recommended approval without restrictions based on the existing safety and usage data.

In March 2009, a Federal court decision, Tummino v. von Eschenbach, directed the FDA to lower the OTC age restriction on Plan B from 18 to 17 years of age. It also required the FDA conduct a re-review of existing scientific evidence and decide whether an age restriction is necessary at all. The FDA has complied with the first directive, and two levonorgestrel emergency contraceptive products, Plan B One-Step® and Next Choice®, are available to women 17 and older.                                                                                                     

Although we have come a long way, the age restriction on the OTC sale of levonorgestrel emergency contraceptive products has no scientific rationale and remains a barrier to access for many adolescents.  The following question and answer document provides the facts and figures based on the available scientific research on the relationship between levonorgestrel emergency contraception and adolescents.