Monday, April 22, 2013

Judge orders morning-after pill available without prescription

Elizabeth Landau
Fri April 5, 2013
Full Article:

A federal judge in Brooklyn, New York, has ordered the U.S. Food and Drug Administration to make the morning-after birth control pill available to people of any age without a prescription.

The order overturned a 2011 decision by Health and Human Services Secretary Kathleen Sebelius to require a prescription for girls under 17.

The FDA said it couldn't comment on an ongoing legal matter. But the U.S. Justice Department indicated an appeal of the ruling was under consideration. "The Department of Justice is reviewing the appellate options and expects to act promptly," department spokeswoman Allison Price said.

The American College of Obstetricians and Gynecologists recommended last year that oral contraceptives be sold over the counter in an effort to reduce the number of unintended pregnancies in the United States. Opponents of prescription requirements say prescriptions can delay access to the drug.

In 2011, Teva Women's Health Inc., maker of Plan B One-Step, had asked the FDA to make the drug available without prescription to all sexually active girls and women. Sebelius overruled the FDA's recommendation, saying, "I do not believe enough data were presented to support the application."

On Friday, U.S. District Court Judge Edward Korman said in his order, "The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable."

Friday's order came in response to a lawsuit launched by the Center for Reproductive Rights. The group was seeking to expand access to all brands of the morning-after pill over the counter, such as Plan B One-Step and Next Choice, so that women of all ages would be able to purchase them without a prescription.

"Today science has finally prevailed over politics," Nancy Northup, the center's president and CEO, said in a statement. "This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods."

In a press briefing, Northup said that according to the order, within 30 days, the pill would be available over the counter without "point of sale restrictions," such as needing to show identification or being a certain age.

There may be other settings besides drugstores where the morning-after pill will be sold, Susan Wood, associate professor at the George Washington University's School of Public Health and Health Services, told reporters.

"We no longer have to find, on a Sunday morning or a Saturday night, an open pharmacy counter with a pharmacist on duty," she said.


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