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Justice Department to appeal judge's Plan B order

U.S. Department of Justice officials have filed notice that they will appeal a federal judge's order requiring the Food and Drug Administration to make the so-called "morning after" pill available without a prescription to all women without age or certain sales restrictions. 

The department also has asked the federal district court to stay its order, which was set to take effect on May 6, according to Allison Price, a spokeswoman. 

The move comes a day after the FDA agreed to lower the age limit to 15 for sales of non-prescription Plan B One-Step emergency contraception and to make the drug available in the general aisles of stores with pharmacies, instead of behind the counter. 

 Justice officials appeared to be concerned by the precedent the order would send in overturning a top administrative decision. Officials said that the court exceeded its authority by specifying action regarding the one-pill Plan B One Step product and by ordering the FDA to make emergency contraception available instead of sending the issue back to the agency for reconsideration, documents showed.

"Although FDA did not take that action for purposes of complying with the April 5 order, the approval has the effect of ensuring that all of the plaintiffs in this case (including the youngest of them) now have access without a prescription and without significant point-of-sale restrictions to at least one form of emergency contraception ..." reads a letter sent late Wednesday by justice officials to U.S. District Judge Edward Korman. "As a result, no plaintiff will be harmed by a stay."

Early last month, the New York judge ordered the FDA to reverse a 2011 agency decision and make emergency contraception containing levonorgestrel available to all women without a prescription and over the counter within 30 days. In the acidly worded ruling, the judge criticized the FDA and Health and Human Services Secretary Kathleen Sebelius for politicizing the availability of a drug that medical experts had concluded was safe and effective for women of all ages. In the 59-page ruling, he said that Sebelius' actions were "politically motivated, scientifically unjustified and contrary to agency precedent." 

But on Tuesday, the FDA granted an amended application from Teva Women's Health Inc., to make just Plan B One-Step available to girls as young as 15 without a prescription starting immediately. Under the previous ruling, the drugs were available without a prescription to girls and women older than 17. Consumers will find the product in the family planning and women's health aisles of stores with in-store pharmacies and they'll be available outside pharmacy hours. But shoppers will have to show identification to buy the products and they won't be sold if ID can't be verified, the FDA said. 

Reproductive-rights advocates who brought the lawsuit that led to Korman's order were frustrated at the decision. 

"Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations," said Nancy Northup, president and chief executive of the Center for Reproductive Rights. "The federal court has made clear that these stalling tactics were based purely on politics, not science."

Terry O'Neill, president of that National Organization for Women, called the move "a step backwards for women's health."

"Millions of women need access to this safe and effective product, and the prevention of unwanted pregnancy, particularly in adolescents, should not be obstructed by politics," she said. 

Officials with Planned Parenthood said that lowering the age at which the drug is available without a prescription was a good move that should go further. 

"The Obama Administration took an important step forward earlier this week by moving emergency contraception out from behind the pharmacy counter and making it available to people ages 15 and older and we continue to believe that access should be expanded further," Cecile Richards, the agency's president, said in a statement.

A doctor who backed wider access said that advocates will still work toward the goal of reducing unwanted pregnancies.

"If someone had said to me years ago that we were allowing a 15-year-old girl to get this, it would be such progress," said Dr. Cora Breuner, a Seattle pediatrician and professor of adolescent medicine who authored the American Academy of Pediatrics guidelines on emergency contraception.

"We're getting there," she said. "It's a step in the right direction." 

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