* Calls FDA rules ‘arbitrary, capricious and unreasonable’
* Pediatricians had recommended access for younger girls
* Appeal considered unlikely
By Jessica Dye
NEW YORK, April 5 (Reuters) - A federal judge on Friday ordered the U.S. Food and Drug Administration to make “morning-after” emergency contraception pills available without a prescription to all girls of reproductive age and criticized the Obama administration for interfering with the process for political purposes.
The ruling in a Brooklyn court is the latest step in the years-long legal saga over the pill known as “Plan B,” a drug that has also sparked political and religious battles. Reproductive-rights groups cheered the decision as overdue, while anti-abortion and some religious groups condemned it.
The order reverses a surprise December 2011 decision by U.S. Health and Human Services Secretary Kathleen Sebelius. After the FDA decided to approve over-the-counter sales with no age limits, Sebelius ordered it to reverse course, barring girls under 17 from buying the pills without a prescription.
President Barack Obama supported that restriction, invoking his daughters. But the timing, 11 months ahead of the presidential eleciton, sparked criticism that he was trying to placate social conservatives.
In his ruling, U.S. District Judge Edward Korman called Sebelius’s decision “arbitrary, capricious and unreasonable.”
“The motivation for the secretary’s action was obviously political,” he wrote.
Scientists and activists who have long been involved in emergency contraception reached the same conclusion about Sebelius’s 2011 decision.
“I thought it was an act of cowardice,” said Dr Michael Greene, professor of obstetrics and gynecology at Harvard Medical School and a long-time adviser to the FDA. “It was during the run-up to the 2012 election, and the administration didn’t want the Republicans to beat them over the head with this” during a campaign when Obama was trying to appeal to middle-of-the-road voters.
Because physicians and doctors advising the FDA had concluded that the morning-after pills were safe for younger adolescents and did not cause promiscuity, critics saw Sebelius’s decision as an instance of politics trumping science - something that particularly riled activists who had been led to expect otherwise.
“In the first days of the administration in 2009, we were told that this White House would make science- and fact-based decisions,” said Jon O‘Brien, president of Catholics for Choice, which supports abortion rights. Ordering the FDA to keep age restrictions on access to emergency contraception “was an exact example of a politically motivated decision, which makes it even more shameful.”
The politicization of emergency contraception has led to speculation that Friday’s decision did the Obama administration a favor.
“This may be a free pass for them,” said Lars Noah, a professor at the University of Florida College of Law. “You can say, ‘our hands were tied, we were forced to cave in.'”
“Whatever the political calculus is, I’d be shocked if they appealed this,” he continued. “They are probably just going to walk away from this one, and maybe thank their lucky stars this is how they got to the right outcome.”
White House press secretary Jay Carney said on Friday that Obama maintains his backing for the Sebelius decision.
“The president supported that decision after she made it,” Carney told reporters, adding, “and he supports that decision today. He believes it was the right common sense approach to this issue.”
An HHS spokesman referred calls to the Justice Department, which said it was reviewing the ruling.
The Center for Reproductive Rights and other groups had petitioned the FDA to strike down age and access limits, saying there was no scientific proof that girls younger than 17 could not safely use the drug without supervision.
Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. “Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception,” she said.
The ruling was also praised by medical groups including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics. Last year, the pediatricians recommended the physicians write advance prescriptions for patients under 17, so girls would have them in hand if they needed emergency contraception but were unable to reach a doctor.
But opponents of abortion decried the ruling and warned that the pill’s widespread availability could spur criminal activity.
“When these are right out there with the bubble gum, they’re going to be part of the date rape cocktail,” said Karen Brauer, president of Pharmacists for Life.
Some pharmacists have refused to dispense emergency contraceptives because it violates their religious faith. Making the pills available over the counter removes the pharmacist’s role in dispensing the drug.
In a statement, the U.S. Conference of Catholic Bishops said, “This ruling should be appealed and overturned.”
In 1999, Teva Pharmaceuticals Ltd’s Plan B became the first emergency contraceptive available by prescription in the United States. The company also markets Plan B One-Step, a one-pill version of Plan B. Actavis Inc markets a generic version of the drug; its shares rose more than 1 percent Friday on what was otherwise a broadly lower day for stocks.
“Teva has received the Court’s decision and we are currently reviewing it,” said company spokeswoman Denise Bradley.
As of February, Plan B U.S. sales over the past 12 months were about $79 million, according to data compiled by IMS Health, which tracks pharmaceutical sales. That is relatively small by pharmaceutical industry standards.
Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.
One FDA veteran praised the decision.
“This has been a 10-year saga during which the FDA was not allowed to do its role properly, not allowed to make science-based decisions,” said Susan Wood.
Wood resigned from the FDA as assistant commissioner for women’s health in 2005 over its decision not to approve over-the-counter sales of emergency contraception. She is now director of the Jacobs Institute of Women’s Health at George Washington University in Washington.
“This decision gives the FDA the chance to reclaim its ability to make decisions based on science, medicine and evidence,” Wood said, “not politics.”
In 2005, the FDA declined to approve over-the-counter sales of the drug, overruling its panel of outside experts as well as its own scientists.