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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 government is moving the morning-after pill over the counter
but only those 15 and older can buy it - an attempt to find middle
ground just days before a court-imposed deadline to lift all age
restrictions on the emergency contraceptive.
Today,
Plan B One-Step is sold behind pharmacy counters, and buyers must prove
they're 17 or older to buy it without a prescription or else see a
doctor first. Tuesday's decision by the Food and Drug Administration
lowers the age limit to 15 - and will allow the pill to sit on drugstore
shelves next to condoms and spermicides or other women's health
products. But customers must prove their age at the cash register.
Teva Women's Health, which makes Plan B, said it would begin over-the-counter sales in a few months.
The
question is whether Tuesday's action settles a larger court fight.
Earlier this month, U.S. District Judge Edward Korman of New York
blasted the Obama administration for imposing the age-17 limit, saying
it had let election-year politics trump science and was making it hard
for women of any age to obtain the emergency contraception in time. He
ordered an end to all age restrictions by Monday, for Plan B and its
generic versions.
The FDA said Tuesday's
decision was independent of the court case and wasn't intended to
address it.
Technically, the FDA approved Teva's application to sell
Plan B in this manner.
The Justice Department
remained mum on whether it planned to appeal Korman's decision, and the
White House had no immediate comment.
The
women's group that sued over the age limits said Tuesday's action is not
enough, and it will continue the court fight if necessary.
Lowering
the age limit "may reduce delays for some young women but it does
nothing to address the significant barriers that far too many women of
all ages will still find if they arrive at the drugstore without
identification," said Nancy Northup, president of the Center for
Reproductive Rights.
The FDA said the Plan B
One-Step will be packaged with a product code that prompts the cashier
to verify a customer's age. Anyone who can't provide such proof as a
driver's license, birth certificate or passport wouldn't be allowed to
complete the purchase. In most states, driver's licenses, the most
common form of identification, are issued at age 16.
"These
are daunting and sometimes insurmountable hoops women are forced to
jump through in time-sensitive circumstances, and we will continue our
battle in court to remove these arbitrary restrictions on emergency
contraception for all women," Northup said.
Other contraceptive contraception advocates called the move promising.
"This
decision is a step in the right direction for increased access to a
product that is a safe and effective method of preventing unintended
pregnancies," said Sen. Patty Murray, D-Wash. "It's also a decision that
moves us closer to these critical availability decisions being based on
science, not politics."
Social conservatives
had opposed any efforts to loosen restrictions on sale of the
morning-after pill, arguing that it was important for parents and
medical professionals to be involved in such decisions involving young
girls.
The group Concerned Women for America
charged that health officials were putting politics and so-called
progress ahead of the health of children as well as women.
"It
makes no sense that kids need parental permission to take aspirin at
school, but they're free to buy and administer Plan B," Penny Nance, CEO
and president of CWA, said in a statement.
Half
the nation's pregnancies every year are unintended, and doctors' groups
say more access to morning-after pills could cut those numbers. The
pills contain higher doses of regular contraceptives, and if taken
within 72 hours of unprotected sex, can cut the chances of pregnancy by
up to 89 percent. But it works best if taken in the first 24 hours.
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 are physically
capable of bearing children but shouldn't be able to buy the
pregnancy-preventing pill on their own.
President
Barack Obama supported Sebelius' move and a spokesman said earlier this
month that the president's position hadn't changed.
The
Justice Department could appeal Korman's ruling and seek a stay. If
granted, the appeals process would move through the courts, while Plan B
is sold over the counter whenever Teva has the product repackaged to
meet FDA's requirements.
Absent a stay, "we
will want to go back to court as quickly as possible and ask the judge
to hold them in contempt," said Janet Crepps, a senior counsel for the
Center for Reproductive Rights.
The FDA said
Tuesday that Teva had provided data proving that girls as young as 15
could understand how Plan B works and use it properly, without the
involvement of a health care provider. Teva plans to conduct a
consumer-education program, and indicated it is willing to audit whether
stores are following the age requirement, the agency said.
FDA
said its ruling applies only to Plan B One-Step, and not to generic
versions of the pill which would remain behind pharmacy counters with
the age-17 restriction.
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.
