"It is irresponsible to advocate over-the-counter use of these high-potency drugs, which would make them available to anyone -- including those predators who exploit young girls," Shaw Crouse said.
In his ruling, Korman dismissed the federal government's earlier arguments and, in particular, previous decisions by U.S. Health and Human Services Secretary Kathleen Sebelius that required girls under 17 to get a prescription for the emergency contraceptive. Korman wrote that Sebelius' actions "with respect to Plan B One-Step ... were arbitrary, capricious and unreasonable."
In 2011, Sebelius overruled a recommendation by the FDA to make the drug available to all women without a prescription. The FDA said at the time that it had well-supported scientific evidence that Plan B One-Step was a safe and effective way to prevent unintended pregnancy.
Sebelius, however, said she was concerned that very young girls couldn't properly understand how to use the drug without assistance from an adult.
She invoked her authority under the federal Food, Drug and Cosmetic Act and directed FDA Commissioner Hamburg to issue "a complete response letter." As a result, "the supplement for nonprescription use in females under the age of 17 is not approved," Hamburg wrote at the time.
The Mayo Clinic has more about emergency contraception.
SOURCES: Janice Shaw Crouse, Ph.D. director and senior fellow, Beverly LaHaye Institute, Concerned Women for America; U.S. Food and Drug Administration, news release, April 30, 2013; Planned Parenthood Federation of America, statement, April 30, 2013; The New York Times; Associat
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