The FDA approved the emergency contraceptive to be sold OTC to girls aged 15 and older, and the Justice Department appealed a judge's order that it be made available OTC to girls of all ages.
The FDA approved the emergency contraceptive to be sold OTC to girls aged 15 and older, and the Justice Department appealed a judge’s order that it be made available OTC to girls of all ages.
This week has seen a flurry of activity regarding access to the emergency contraceptive Plan B (levonorgestrel). On Tuesday, April 30, the FDA announced that Plan B One-Step, a single-pill version, would be made available over-the-counter to girls 15 and older. A day later, the Justice Department appealed a federal judge’s order that Plan B be made available over-the-counter to all girls regardless of age.
Access to Plan B has been a matter of controversy for the past decade. The drug, which is most effective at preventing pregnancy when taken within 3 days of unprotected sexual intercourse, required a prescription when it was first introduced in 1999. The FDA rejected a 2003 petition from its manufacturer for the drug to be made available over-the-counter. In 2006, however, the agency decided to make Plan B available without a prescription to women 18 and older, although it had to be requested from a pharmacist. This age limit was lowered to 17 by judicial order in 2009.
In 2011, Teva Pharmaceuticals, the manufacturer of Plan B One-Step, applied for the medication to be sold over-the-counter without age restrictions. The FDA recommended approval of this request, but was overruled by Health and Human Services Secretary Kathleen Sebelius, who said that her decision was based on a lack of research on the drug’s safety in girls as young as 11, some of whom can get pregnant.
On April 5, 2013, US District Court Judge Edward Korman called Sebelius’s decision to overrule the FDA “arbitrary, capricious, and unreasonable” and ordered that Plan B be made available over-the-counter to all girls regardless of age. Korman, who gave the Obama administration 30 days to comply with his order or appeal, added that “the secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent.”
According to the FDA’s decision this week, Plan B One-Step will be made available without a prescription to girls 15 and older and will be displayed on shelves along with other over-the-counter products so that it is available to patients during normal retail operating hours, regardless of whether the pharmacy is open. In a press release announcing the decision, the FDA noted that it was made in response to a petition from Teva Pharmaceuticals that preceded Judge Korman’s order.
FDA Commissioner Margaret Hamburg, MD, explained the agency’s reasoning in the press release: “Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States. The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”
In announcing that it would appeal Judge Korman’s order, the Justice Department argued that the judge did not have the authority to direct the FDA to take specific action and should instead have sent the issue back to the agency for review. The Justice Department also argues that Korman’s order and its appeal apply only to the original 2-dose version of Plan B, not the single-dose version covered by the FDA’s decision.
Scientists at FDA as well as groups such as the American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have advocated access to emergency contraception without age restrictions for years. Anti-abortion activists and conservative groups, on the other hand, have argued against loosening restrictions.
Plan B One-Step consists of a single dose of levonorgestrel (1.5 mg tablet). The original version of Plan B includes 2 doses of levonorgestrel (.75 mg per tablet) taken 12 hours apart, is available from several generic manufacturers, and continues to require a prescription for those under age 17. Another emergency contraceptive drug available in the United States, ella (ulipristal), is available by prescription only, and can prevent pregnancy if taken within 120 hours (5 days) of unprotected sexual intercourse.