ACOG Statement on Single-Dose EC Reformulation
July 15, 2009
Washington, DC -- The US Food and Drug Administration's (FDA) approval of a new one-pill formulation of the emergency contraceptive Plan B® represents a positive step forward for women's health, according to The American College of Obstetricians and Gynecologists (ACOG). The new formulation of emergency contraception (EC), called Plan B® One-Step, will simplify this important pregnancy prevention treatment.
Last month, the FDA also approved Next Choice™, a generic version of the original two-pill Plan B® formulation. At this time, the generic EC is obtainable by prescription only to those ages 17 and younger.
In July 1999 the FDA approved Plan B® by prescription only. In 2003, Plan B®'s manufacturer filed an application with the FDA to make the contraceptive available over the counter without a prescription. After an unusually delayed decision, the FDA granted behind-the-counter nonprescription status for EC but only to those age 18 and older. Earlier this year, after a federal district court in New York ordered the FDA to make EC available without a prescription to women younger than age 18, the FDA lowered the age limit to 17 for nonprescription EC.
Although ACOG is encouraged by recent FDA actions, it reiterates its long-held position that there is no valid scientific or medical reason to impose an age restriction on the availability of EC because it is safe and effective for adolescents and women of all ages. ACOG again urges the FDA to withdraw the age restriction altogether and eliminate the behind-the-counter status for EC.
The American College of Obstetricians and Gynecologists (ACOG) is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 56,000 members, ACOG: strongly advocates for quality health care for women; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing women's health care.