Labeling emergency contraception.

Abstract

According to the signers of a November 28 citizens' petition filed with the Food and Drug Administration (FDA), unintended pregnancies and abortions could be reduced significantly if the FDA would require the relabeling of several oral contraceptives as emergency or postcoital contraception, also known as "morning after pills." It has long been established that within 72 hours after unprotected intercourse or contraceptive failure, a specified combination of pills taken at specified intervals can reduce the risk of pregnancy by an estimated 75%. Although physicians at university health clinics, in hospital emergency rooms treating rape victims, and at some family planning clinics prescribe emergency contraceptives, other physicians are reluctant to do so without relabeling, and most women taking the pill do not know the correct dosage. Calling this a "critical public health issue," attorneys at the Center for Reproductive Law and Policy petitioned the FDA for a labeling change on the grounds that manufacturers are in fact "misbranding" pills by suppressing emergency contraceptive information. If pill makers rewrite their patient packet inserts, women undoubtedly would have far greater control over the occurrence of an unintended pregnancy, the attorneys said.