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Judge OKs 'morning-after pill' for girls of all ages

12:03 PM, Apr 5, 2013   |    comments
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By Doug Stanglin, USA TODAY 

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.

The ruling 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.

The 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.

Cecile 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.

"This 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."

Higgins also 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.

The 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 filibuster."

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.

Morning-after pills do not end a pregnancy that has implanted, according to the Mayo Clinic, and should not be confused with abortion pills.

The clinic 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."

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