THURSDAY, May 2 (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
"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
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
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
Other brands of emergency contraception include Next Choice and
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 Timesreported.
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,
"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
Women's health advocates praised the FDA decision earlier this
"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
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
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
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