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| 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 days before a court-imposed deadline. On April 30, 2013, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription — and said it no longer has to be kept behind pharmacy counters. Instead, the pill can sit on drugstore shelves just like condoms, but that buyers would have to prove their age at the cash register. |
WASHINGTON
(AP) -- The Obama administration on Wednesday appealed a federal judge's
order to lift all age limits on who can buy morning-after birth control
pills without a prescription.
In appealing
the ruling, the administration recommitted itself to a position Obama
took during his re-election campaign that younger teens shouldn't have
unabated access to emergency contraceptives, despite the insistence by
physicians groups and much of his Democratic base that the pill should
be readily available.
A day earlier, the Food
and Drug Administration lowered the age that people can buy the Plan B
One-Step morning-after pill without a prescription to 15 - younger than
the current limit of 17 - and decided that the pill could be sold on
drugstore shelves near the condoms, instead of locked behind pharmacy
counters.
That decision appeared to fly in the
face of a judge's decision last month that women of any age should be
allowed to buy both Plan B and its cheaper generic competition as easily
as they can buy aspirin. U.S.
District Judge Edward Korman of New York
gave the FDA 30 days to comply, and the Monday deadline was approaching
fast, prompting the administration on Wednesday to ask the court to put
the ruling on hold while it reconsiders.
With
the appeal, the Obama administration is making clear that it's willing
to ease access to emergency contraception only a certain amount - not
nearly as broadly as doctors' groups and contraception advocates have
urged. Still, the FDA decision moving the pill from behind the counter
to drugstore shelves reflected a societal shift in the long battle over
women's reproductive rights, marking a major milestone for those who
believe all forms of birth control should be easy to buy.
Reluctant
to get drawn in to a messy second-term spat over social issues, White
House officials insisted Wednesday that both the FDA and the Justice
Department were acting independently of the White House in deciding how
to proceed. But the decision to appeal was certain to irk
abortion-rights advocates who say they can't understand why a Democratic
president is siding with social conservatives in favor of limiting
women's reproductive choices.
"We are deeply
disappointed that just days after President Obama proclaimed his
commitment to women's reproductive rights, his administration has
decided once again to deprive women of their right to obtain emergency
contraception without unjustified and burdensome restrictions," said
Nancy Northup, president of the Center for Reproductive Rights, which
filed the lawsuit that prompted Korman's ruling.
Current
and former White House aides said Obama's approach to the issue has
been heavily influenced by his experience as the father of two
school-age daughters. Obama and Health and Human Services Secretary
Kathleen Sebelius have also questioned whether there's enough data
available to show the morning-after pill is safe and appropriate for
younger girls, even though physicians groups insist that it is.
In
Wednesday's filing, the Justice Department said Korman exceeded his
authority and that his decision should be suspended while that appeal is
under way, meaning only Plan B One-Step would appear on drugstore
shelves until the case is finally settled. If Korman's order isn't
suspended during the appeals process, the result would be "substantial
market confusion, harming FDA's and the public's interest" as drugstores
receive conflicting orders about who's allowed to buy what, the Justice
Department concluded.
Rather than take
matters into his own hands, the Justice Department argued to the 2nd
U.S. Circuit Court of Appeals that Korman should have ordered the FDA to
reconsider its options for regulating emergency contraception. The
court cannot overturn the rules and processes that federal agencies must
follow "by instead mandating a particular substantive outcome," the
appeal states.
The FDA actually had been
poised to lift all age limits and let Plan B sell over the counter in
late 2011, when Kathleen Sebelius 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.
Sebelius' move was unprecedented,
and Korman had blasted it as election-year politics - meaning he was
overruling not just a government agency but a Cabinet secretary.
More
than a year later, neither side in the contraception debate was happy
with the FDA's surprise twist, which many perceived as an attempt to
find a palatable middle ground between imposing an age limit of 17 and
imposing no limit at all.
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.
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.
Social
conservatives were outraged by the FDA's move to lower the age limits
for Plan B - as well as the possibility that Korman's ruling might take
effect and lift age restrictions altogether.
"This
decision undermines the right of parents to make important health
decisions for their young daughters," said Anna Higgins of the Family
Research Council.
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. At the same time, however, White House spokesman Jay
Carney said Obama's concern had been about girls younger than 15 having
access, suggesting an age limit of 15 might be acceptable.
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.
