FDA OK's Morning-After Pill Without a Prescription
Females aged 15 or older to gain access to Plan B drug over-the-counter
WebMD News Archive
Women's health advocates praised the FDA decision.
"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," Cecile Richards, president of Planned Parenthood Federation of America, said in a news release.
"Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex," she added. "This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."
But not everyone is likely to be pleased with the move.
Earlier this month, Janice Shaw Crouse -- director and senior fellow at the Beverly LaHaye Institute, the think tank for the conservative women's group Concerned Women for America -- called Korman's ruling "a political decision, made by those who stand to profit financially from an action that puts ideology ahead of the nation's girls and young women."
"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 was dismissive of the government's 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 is 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 Margaret 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.