* Calls FDA rules 'arbitrary, capricious and unreasonable'
* Pediatricians had recommended access for younger girls
* Appeal considered unlikely
By Jessica Dye
NEW YORK, April 5 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
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
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
The politicization of emergency contraception has led to
speculation that Friday's decision did the Obama administration
"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
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
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.