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October 20, 2014

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Girls of any age can buy morning-after pill for now

Image

Associated Press

This undated image made available by Teva Women’s Health shows the packaging for its Plan B One-Step (levonorgestrel) tablet, one of the brands known as the “morning-after pill.”

NEW YORK — Girls of any age can buy generic versions of emergency contraception without prescriptions while the federal government appeals a judge's ruling allowing the sales, a federal appeals court said Wednesday.

The order, the latest in a series of rulings in a complex back-and-forth over access to the drug, was met with praise from advocates for girls' and women's rights and scorn from social conservatives and other opponents, who argue the drug's availability takes away the rights of parents of girls who could get it without their permission.

The brief order issued by the 2nd U.S. Circuit Court of Appeals in Manhattan permitted two-pill versions of emergency contraception to immediately be sold without restrictions, but the court refused to allow unrestricted sales of Plan B One-Step until it decides the merits of the government's appeal. It did not specify why the two-pill versions were being allowed now, though it said the government failed to meet the requirements necessary to block the lower-court decision.

Department of Justice spokeswoman Allison Price said the government was reviewing the court's order.

Center for Reproductive Rights President Nancy Northup called the day of the court's order a "historic day for women's health."

"Finally, after more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous and medically unnecessary restrictions to get emergency contraception," she said in a statement.

The center's litigation director, Julie Rickelman, said the government has two weeks to decide whether to appeal the 2nd Circuit's decision on the stay to the full appeals court or the Supreme Court. Even if there is no appeal of the stay ruling, it was unclear how soon drugstores would move the two-pill emergency contraception from behind the counter. She said she hoped the pills would be available without restriction within a month.

"What it does mean is that generic two-pill products are going to be readily available to women without age restrictions, on any drugstore shelf," Rickelman said. "It'll be like buying Tylenol. You'll be able to go get it off the drugstore shelf, no ID, at the regular counter."

Anna Higgins, director of the Family Research Council's Center for Human Dignity, where she focuses on issues including conception and end-of-life care, said the ease of access to the drug was the problem. She described the court's order Wednesday as "confounding."

"Our reaction in general is a concern for the safety of young girls and the rights of parents," she said.

But Dr. Georges Benjamin, of the American Public Health Association, said the court was right to allow women of child-bearing age to have access to emergency contraception, saying he was "hopeful that the full appeals court, when it finally decides, will have the same view."

The government has appealed U.S. District Judge Edward Korman's underlying April 5 ruling, which ordered emergency contraceptives based on the hormone levonorgestrel be made available without a prescription, over the counter and without point-of-sale or age restrictions.

The government asked the judge to suspend the effect of that ruling until the appeals court could decide the case, but the judge declined, saying the government's decision to restrict sales was "politically motivated, scientifically unjustified and contrary to agency precedent." He also said there was no basis to deny the request to make the drugs widely available.

The government had argued that "substantial market confusion" could result if the judge's ruling were enforced while appeals were pending, only to be later overturned.

The morning-after pill contains a higher dose of the female progestin hormone than is in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent. But it works best within the first 24 hours. If a girl or woman already is pregnant, the pill has no effect. It prevents ovulation or fertilization of an egg.

The Food and Drug Administration was preparing in 2011 to allow over-the-counter sales of the morning-after pill with no limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move.

The FDA announced in early May that Plan B One-Step could be sold without a prescription to those 15 and older. Its maker, Teva Women's Health, plans to begin those sales soon. Sales had previously been limited to those who were at least 17.

Korman, the judge, later ridiculed the FDA changes, saying they established "nonsensical rules" that favored sales of the Plan B One-Step morning-after pill and were made "to sugarcoat" the government's appeal.

He also said they place a disproportionate burden on blacks and the poor by requiring a prescription for less expensive generic versions of the drug bought by those under age 17 and by requiring those over age 17 to show proof-of-age identification at a pharmacy.

Plan B One-Step is the newer version of emergency contraception — the same drug but combined into one pill instead of two.

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  1. ...well, ain't that nice...