Federal judge orders morning-after pill available without prescription
DENVER — A federal judge in Brooklyn, New York, has ordered the U.S. Food and Drug Administration to make the morning-after birth control pill available to people of any age without a prescription.
The order overturned a 2011 decision by Health and Human Services Secretary Kathleen Sebelius to require a prescription for girls under 17.
The FDA said it couldn’t comment because it is an ongoing legal mater.
The American College of Obstetricians and Gynecologists recommended last year that oral contraceptives be sold over the counter in an effort to reduce the number of unintended pregnancies in the United States. Opponents of prescription requirements say prescriptions can delay access to the drug.
In 2011, Teva Woman’s Health Inc, maker of Plan B One-Step, had asked the FDA to make the drug available without prescription to all sexually active girls and women. Sebelius overruled that recommendation, saying “I do not believe enough data were presented to support the application.”
On Friday, U.S. District Court Judge Edward Korman said, “The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable.”
Planned parenthood of Denver spokeswoman Monica McCafferty called the announcement a “huge triumph for women” and added that it marks an important step for women of all ages.
“We now have an environment where women can get E.C. and not face intimidation or fear or judgment,” McCafferty said.
Friday’s order came in response to a lawsuit launched by the Center for Reproductive Rights. The group was seeking to expand access to all brands of the morning-after pill over the counter, such as Plan B One-Step and Next Choice, so that women of all ages would be able to purchase them without a prescription.
“Today science has finally prevailed over politics,” Nancy Northup, the center’s president and CEO, said in a statement. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods.”
But the Family Research Council expressed concerns about the order.
“There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today’s ruling removes these commonsense protections,” Anna Higgins, director of the organization’s Center for Human Dignity, said in a statement.
The FDA approved Plan B in 1999. The key ingredient in Plan B is a synthetic hormone called levonorgestrel.
This drug stops an egg from being released from the ovary, or preventing fertilization of the egg by sperm.
If there has been fertilization, Plan B may prevent a fertilized egg from embedding in the uterus. But if the egg has already been implanted in the uterus, the morning-after pill will not work.
Emergency contraceptives are intended for use within 72 hours after sex but are most effective if taken within 24 hours.
Many developed countries require a prescription for oral contraceptives, including Canada and most of Europe, but other countries sell the pill without a prescription even formally or informally.
A 2012 study in the journal Pediatrics found that there is misinformation about emergency contraception, including about what age women can obtain it without a prescription, and who can take it in general.
CNN contributed to this report.AlertMe