A federal judge in New York, slamming the government over
foot-dragging and administrative "filibuster," has ordered the Food and
Drug Administration to make the "morning-after" pill available without
prescription to girls of all ages within one month.
overturns a decision in 2011 by Health and Human Services Secretary
Kathleen Sebelius that barred over-the-counter sales of the
controversial pill to girls under 17. Sebelius' decision itself had overruled an FDA recommendation to widen availability of the drug.
pill, popularly known as "Plan B," typically works up to 72 hours after
intercourse, and is distinct from the so-called "abortion pill."
U.S. District Judge Edward Korman, of Brooklyn, said his order must be carried out within a month.
Richards, president of Planned Parenthood, hailed the ruling as "a
significant and long-overdue step forward for women's health that will
benefit women of all ages."
"When a woman fears she might become
pregnant after her contraceptive has failed or she has had unprotected
sex, she needs fast access to emergency contraception, not delays at the
pharmacy counter," Richards said in a statement. "Lifting these
restrictions will allow emergency contraception to be stocked on store
shelves, making it more accessible to everyone."
In a statement, the Family Research Council raised what it called serious concerns about the ruling.
ruling places the health of young girls at risk," said Anna Higgins,
director of the council's Center for Human Dignity. "Making Plan B
available for girls under the age of 17 without a prescription flies in
the face of medical information and sound judgment."
expressed concern that the over-the-counter availability of Plan B for
girls of any age would put many at further risk of sexually transmitted
infections because it circumvents necessary medical screening for
sexually active girls.
She also said that there is a "real danger" that Plan B may be given to young girls, under coercion or without their consent. "
There was no immediate comment from HHS or the Department of Justice.
judge said the case isn't about the potential misuse of the so-called
morning-after pill by 11-year-olds. He said the contraceptives would be
among the safest drugs sold over the counter. He said the number of
11-year-olds likely to use the drugs was minuscule.
In his 59-page
ruling, Korman said that Sebelius, in overruling the FDA, had forced
the agency to "to ride roughshod over the policies and practices that it
has consistently applied in considering applications for switches in
drug status to over-the-counter availability."
Korman, who was
appointed to the court by President Reagan in 1985, also noted that the
FDA itself had engaged in its own foot-dragging over the years, dating
from the Bush administration, when the plaintiffs first began trying to
get it to rule on Plan B more than 12 years ago.
"The FDA has
engaged in intolerable delays in processing the petition," he wrote.
"Indeed, it could accurately be described as an administrative agency
He was particularly caustic regarding the FDA's call
for public comment on whether it needed to engage in rulemaking in order
to adopt an age-restricting marketing regime.
"After eating up
eleven months, 47,000 public comments, and hundreds of thousands, if not
millions, of dollars," Korman wrote. "It decided that it did not need
rulemaking after all. The plaintiffs should not be forced to endure, nor
should the agency's misconduct be rewarded by, an exercise that permits
the FDA to engage in further delay and obstruction."
Last year, the American College of Obstetricians and Gynecologists recommended that
oral contraceptives be sold over the counter without a prescription to
help lower the nation's high unintended pregnancy rate.
pills do not end a pregnancy that has implanted, according to the Mayo
Clinic, and should not be confused with abortion pills.
says morning-after pills, which have been widely available in Europe
and Latin America for several years, can prevent pregnancy "because
conception typically doesn't occur immediately after sex."