Thursday, December 5, 2013
By Lauran Neergaard / The Associated Press
(Continued from page 1)
This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill."
Half the nation's pregnancies every year are unintended, and doctors groups say more access to morning-after pills could cut those numbers. The pills contain higher doses of regular contraceptives and, if taken within 72 hours of unprotected sex, can cut the chances of pregnancy by up to 89 percent. But they work best if taken in the first 24 hours.
The FDA had been poised to lift all age limits and let Plan B be sold over the counter in late 2011, but Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.
President Barack Obama supported Sebelius' move and a spokesman said the president's position hadn't changed.
The Justice Department could appeal Korman's ruling and seek a stay. If granted, the appeals process would move through the courts, while Plan B is sold over the counter whenever Teva has the product repackaged to meet the FDA's requirements.
Absent a stay, "we will want to go back to court as quickly as possible and ask the judge to hold them in contempt," said Janet Crepps, a senior counsel for the Center for Reproductive Rights.
The FDA said Tuesday that Teva had provided data proving that girls as young as 15 could understand how Plan B works and use it properly, without the involvement of a health care provider. Teva plans to conduct a consumer-education program and indicated it is willing to audit whether stores are following the age requirement, the agency said.
The FDA said its ruling applies only to Plan B One-Step, and not to generic versions of the pill, which would remain behind pharmacy counters with the age-17 restriction.
If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists — and Korman, in his ruling — said has been discredited.