White House to Challenge Ruling on Unlimited Access to 'Morning-After' Pill
Move follows FDA decision that only women 15 or older could get emergency contraceptive without prescription
THURSDAY, May 2, 2013 (HealthDay News) -- The Obama administration announced late Wednesday that it would appeal a federal judge's order to eliminate any age restrictions on who can buy morning-after birth control pills without a prescription.
The move follows a Tuesday decision by the U.S. Food and Drug Administration to lower the age at which females can buy the Plan B One-Step morning-after pill -- girls age 15 years of age and older will now have access, compared to the prior limit of 17.
With Wednesday's appeal, the federal government has indicated that it only wants to ease access to emergency contraception by a certain degree, the Associated Press reported.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," FDA Commissioner Dr. Margaret Hamburg said in an agency news release.
"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," she said.
The emergency contraceptive is made by Teva Women's Health Inc.
To prevent girls under the age of 15 from buying Plan B, the FDA said the product would bear a label stating that proof of age be required, and a special product code would prompt such an inquiry from the cashier. "In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft," the FDA noted.
On April 5, Judge Edward Korman, from the Eastern District of New York, gave the FDA 30 days to remove age restrictions on the sale of emergency contraception, such as Plan B One-Step. Until then, girls 16 and younger needed a doctor's prescription to get the pill, which typically works if taken within 72 hours after intercourse.
Other brands of emergency contraception include Next Choice and Ella.
Wednesday's appeal by the Justice Department is in keeping with an election-year decision by President Barack Obama's administration to block the drug's makers from selling it without a prescription or age restriction. And it reignites the hotly contested debate over emergency contraception, The New York Times reported.
The appeal meshes with the views of numerous conservative, anti-abortion groups that don't want contraceptives available to young girls. But it clashes with advocates for women's reproductive health and abortion rights who say years of scientific research found Plan B safe and effective for women of all ages, the Times said.
"Age barriers to emergency contraception are not supported by science, and they should be eliminated," Cecile Richards, the president of Planned Parenthood Federation of America, said in a statement on Wednesday.
The appeal is the latest development in a 10-year, controversial debate about who should have access to the drug and why.
Plan B prevents implantation of a fertilized egg in a woman's uterus through use of levonorgestrel, a synthetic form of the hormone progesterone used for decades in birth control pills. Plan B contains 1.5 milligrams of levonorgestrel, more than "the Pill" contains. It is considered a form of birth control, not abortion.
Women's health advocates praised the FDA decision earlier this week.
"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," Planned Parenthood's Richards said in a news release.
But not everyone was pleased with the push for wider access to Plan B.
Earlier this month, Janice Shaw Crouse -- director and senior fellow at the Beverly LaHaye Institute, a 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 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.