The controversial pill known as “Plan B” typically works up to 72 hours after intercourse.
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.”
READ: The full ruling
FIRST TAKE: The decision turns politics upside down
U.S. District Judge Edward Korman, of Brooklyn, said his order must be carried out within a month.
White House spokesman Jay Carney said that Justice Department officials were reviewing the ruling, but reiterated the president’s support for Sebelius’s original decision to place age restriction on the sale of the drug.
“Secretary Sebelius made this decision. The president supported that decision after she made it,” Carney said. “He supports that decision today. We believe that it was the right, common-sense approach to this issue.”
The Department of Justice “is reviewing the appellate options and expects to act promptly,” spokeswoman Allison Price said.
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. ”
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.”
Lawrence Finer, director of domestic research for the Guttmacher Institute in New York, a non-profit group that studies reproductive and sexual health, says the focus of HHS secretary Kathryn Sebelius and President Obama on girls 10-11 in their past decision to restrict sales of Plan B to women 17 and older, “was misplaced.”
“Very few girls that young are involved in sexual activity,” Finer says. “Rather, a substantial minority of young women aged 15 to 16 are sexually active, and they are old enough to initiate emergency contraception in most cases. They are the ones who had been hurt by the decision.”
Last year, the American College of Obstetricians and Gynecologists recommendedthat 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.”
According to the Mayo Clinic:
“Pregnancy may happen up to several days later. During the time between sex and conception, sperm travel through the fallopian tubes until they potentially reach an egg. Depending on where you are in your menstrual cycle, morning-after pills may act by one or more of the following actions: delaying or preventing ovulation, blocking fertilization, or keeping a fertilized egg from implanting in the uterus.”
Korman, who also worked in the solicitor general’s office during the NIxon administration, served 22 years on the U.S. District Court for the Eastern District of New York, including a role as chief judge. He is currently serving in a “senior status,” which amounts to semi-retirement.
Federal Order to FDA on Morning After Pill by Doug Stanglin
Contributing: Dan Vergano, USA TODAY
“Finally science won and the years of unnecessary politicization of a safe and effective contraceptive are over,” said Susannah Baruch, interim president & CEO of the Reproductive Health Technologies Project.