Justice Dept to appeal morning-after case
By LAURAN NEERGAARD and JOSH LEDERMAN, Associated Press
May 1, 2013 6:54 PM CDT
This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." The Plan B morning-after pill is moving over-the-counter, a decision announced by the Food and Drug Administration just...   (Associated Press)

The Justice Department is appealing a judge's decision lifting all age limits on the Plan B morning-after birth control pill and a cheaper generic.

The federal government says the judge who issued the ruling had exceeded his authority and that his decision should be suspended while the appeal is underway.

U.S. District Judge Edward Korman of New York had given the Food and Drug Administration until Monday to lift all age limits on Plan B and cheaper generic. The judge mandated that emergency contraception be sold just like aspirin.

On Tuesday, the FDA said anyone 15 or older could begin buying one brand, Plan B One-Step, without a prescription _ two years younger than the current age limit of 17.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below.

Selling the morning-after birth control pill right next to condoms, even if limited to buyers 15 or older, marks a big societal shift in the long battle over women's reproductive rights. Backed into a corner by a federal court, the Obama administration is considering how to proceed after what looked like a stab at compromise just made both sides madder.

The politically volatile debate reflects a reality that's difficult for parents, including the president, to swallow: Quite a number of teenagers have sex. So how easily should they be able to get a pill that prevents pregnancy if taken soon enough after sex?

On Tuesday, the Food and Drug Administration made it a little easier, saying anyone 15 or older could begin buying one brand, Plan B One-Step, without a prescription _ two years younger than the current age limit of 17 _ and that the pill no longer has to be locked behind pharmacy counters.

But it's far from clear whether that will happen. U.S. District Judge Edward Korman of New York had given the FDA until Monday to lift all age limits on Plan B and a cheaper generic, mandating that emergency contraception be sold just like aspirin. Instead, by requiring that buyers prove their age at the cash register, the FDA decided to treat it like beer.

The Justice Department hasn't said whether it will appeal Korman's order and thus back FDA's new approach, and that leaves the whole issue in limbo.

"This is a truly bizarre and unprecedented situation," said American University law professor Lewis A. Grossman, a specialist in food and drug law.

On Wednesday, doctors' groups, led by the American College of Obstetricians and Gynecologists, urged the Obama administration not to let the FDA action be the last word.

Any over-the-counter access marks a long-awaited change, but it's not enough, said Dr. Cora Breuner of the American Academy of Pediatrics, which supports nonprescription sale of the morning-after pill for all ages.

"We still have the major issue, which is our teen pregnancy rate is still too high," Breuner said.

Even though few young girls likely would use Plan B, which costs about $50 for a single pill, "we know that it is safe for those under 15," she said.

Most 17- to 19-year-olds are sexually active, and 30 percent of 15- and 16-year-olds have had sex, according to a study published last month by the journal Pediatrics. Sex is much rarer among younger teens. Likewise, older teens have a higher pregnancy rate, but that study also counted more than 110,000 pregnancies among 15- and 16-year-olds in 2008 alone.

The White House sought Wednesday to put much as much distance as possible between President Barack Obama and this political hot potato.

"The president, the White House, did not weigh in on this decision," White House spokesman Jay Carney said of the FDA's move.

Obama must balance his own instincts as the father of two school-age daughters with the wishes of numerous political constituencies, including women's groups whose influence runs deep within the Democratic Party. It was just last week that Obama became the first president to address Planned Parenthood in person, telling the abortion rights group that as long as women must fight to make their own health choices, "you've also got a president who's going to be right there with you fighting every step of the way."

Contraception advocates see a double standard. No one is carded when buying a condom, but under the FDA's decision they would have to prove their age when buying a pill to prevent pregnancy if that condom breaks.

"This isn't a compromise. This is wrong," said Cynthia Pearson of the National Women's Health Network.

Likewise, social conservatives were outraged by the FDA's move, saying it was important for parents and medical professionals to be involved in such decisions involving teens.

"This decision undermines the right of parents to make important health decisions for their young daughters," said Anna Higgins of the Family Research Council. She added that removing the prescription requirement meant "teens and women will avoid necessary medical screenings" that could detect serious problems.

The FDA had been poised to lift all age limits and let Plan B sell over the counter in late 2011, when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 were physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.

Ruling earlier this month in a lawsuit challenging that decision, Korman blasted the Obama administration for letting election-year politics trump science. The judge called the morning-after pill "among the safest drugs sold over the counter," and gave the government 30 days to lift all age limits.

Obama aides bristled at the suggestion that the FDA decision was an attempt at political compromise, insisting the FDA merely responded to an application filed by Plan B's manufacturer which sought the 15 age limit and over-the-counter sales.

At the same time, Carney signaled that a policy allowing 15-year-olds to buy the pill off the shelf would be more palatable to Obama than the prospect of 11-year-olds having unfettered access. Pointing to Obama's comments in support of Sebelius back in 2011, Carney said, "he referred to younger girls, and I believe so did Secretary Sebelius."

If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists _ and Korman, in his ruling _ said has been discredited.