Age, sale restrictions lifted for Plan B One-Step

Abstract

the proper amendments with FDA. In a June 12 memorandum, Judge Edward R. Korman of the Eastern District of New York ruled that the Obama administration’s proposal was suffi cient to comply with his order “to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.” The ruling ended a lawsuit brought in 2005 by organizations and individuals concerned with women’s health, as well as minors and their parents, to challenge FDA’s denial of a 2001 citizen petition seeking OTC access to Plan B for all ages. As things stood before the new developments, Plan B was OTC only for women aged 17 years and older if purchased at a pharmacy with government-issued proof of age; Plan B— which consists of two doses—is no longer marketed, but generic versions of Plan B are available. Plan B One-Step, approved by FDA in 2009, was only OTC subject to the same requirements until the agency decided on April 30, 2013, to make Plan B One-Step available OTC for women aged 15 years and older, just 1 day before the administration fi led a notice of appeal and a motion to stay the judge’s April order.