A package
of the Plan B contraceptive
displayed at a Californian pharmacy on
April 5,
2013 (Getty Images/AFP/File,
Justin Sullivan)
|
The
reversal on the politically sensitive issue means that anyone, including young
girls, will soon be able to purchase the popular Plan B One-Step morning-after
pill over the counter, without a prescription.
President
Barack Obama's administration had fought against US District Court Judge Edward
Korman's order seeking to make the drug more widely available after a more than
decade-long court fight, warning of health and social dangers.
In a letter
to US District Judge Edward Korman, US attorneys said the Food and Drug
Administration was dropping its appeal.
"To
comply with the order, FDA has asked the manufacturer of Plan B One-Step (PBOS)
to submit a supplemental application seeking approval of the one-pill product
to be made available OTC without any such restrictions," the agency said
in a statement.
"Once
FDA receives that supplemental application, the FDA intends to approve it
promptly."
Levonorgestrel-based
emergency contraception contains the same active ingredients as birth control
pills but at higher doses, and may prevent pregnancy if taken within 72 hours
after unprotected intercourse.
The Center
for Reproductive Rights, which brought the latest lawsuit, hailed the FDA's
"significant step forward" but criticized the administration for
"unjustifiably" preventing generic, more affordable brands of
emergency contraception to be made widely available.
"We
are pleased that women should soon be able to buy Plan B One-Step without the
arbitrary restrictions that kept it locked behind the pharmacy counter when
they needed it most urgently," the center's president and CEO Nancy
Northrup said in a statement.
"But
we will continue to fight for fair treatment for women who want and need more
affordable options."
In April,
the FDA approved Plan B One-Step for girls aged 15 and up -- reducing the age
restriction by two years.
But the
move only applied to one brand of emergency contraception, and required that it
be security-tagged to avoid theft and only sold over the counter in stores that
have a pharmacy.
It followed
an order by Korman for the government to make levonorgestrel-based emergency
contraception available without prescription or point of sale restriction.
Korman had
slammed Health and Human Services Secretary Kathleen Sebelius's decision
overruling the FDA to require teens under 17 to obtain a prescription as
"politically motivated" and "scientifically unjustified."
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