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Tuesday, June 11, 2013

Feds: Morning-after pill appeal officially on hold

Feds: Morning-after pill appeal officially on hold

AP Photo
FILE - This undated file photo provided by Barr Pharmaceuticals Inc., shows a package of Plan B One-Step, an emergency contraceptive. The federal government on Monday, June 10, 2013 told a judge it will reverse course and take steps to comply with his order to allow girls of any age to buy emergency contraception without prescriptions.

NEW YORK (AP) -- The Obama administration's appeal in the legal fight over morning-after pills has been officially put on hold until a judge weighs a new plan to allow girls of all ages to buy the contraceptives without a prescription, according to a government letter filed Tuesday.

Lawyers with the Department of Justice and those for the plaintiffs who sued over the issue told the clerk for the federal appeals court in Manhattan that they wanted to suspend the appeals case until they hear again from U.S. District Court Judge Edward Korman, U.S. Attorney Loretta Lynch said in the letter.

The government had appealed the judge'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.

But on Monday, the Department of Justice notified him that it was reversing course and seeking prompt Food and Drug Administration approval of all-age sales - an announcement that pleased girls' and women's rights advocates who said it was long overdue and disappointed social conservatives who claim it threatens the rights of parents and their children.

"It is the government's understanding that the course of action ... fully complies with the district court's judgment in this action," Lynch wrote.

She added that if the judge agrees, "we intend to file with this court notice that the government is voluntarily withdrawing the above-referenced appeal."

It was unclear when the judge would address the issue. A woman answering the phone in his chambers on Tuesday declined to comment.

The government had originally 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 of the morning-after pill 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.

Last week, an appeals court dealt the government a setback by saying it would immediately permit unrestricted sales of the two-pill version of the emergency contraception until the appeal was decided.

The morning-after pill contains a higher dose of the female hormone progestin 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, which prevents ovulation or fertilization of an egg, has no effect.

The FDA 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 late April that Plan B One-Step, the newer version of emergency contraception, the same drug but combined into one pill instead of two, could be sold without a prescription to those age 15 or 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.

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.

Reluctant to get drawn into a messy second-term spat over social issues, officials in President Barack Obama's White House have argued that the FDA and the Department of Justice were acting independently of the White House in deciding how to proceed.

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