April 30, 2013

FDA approves over-the-counter morning-after pill

However, only those who can prove they are at least 15 years old may buy the drug, which prevents pregnancy.

The Associated Press

(Continued from page 1)

click image to enlarge

Plan B One-Step is one brand known as the "morning-after pill."

The Associated Press/Teva Women's Health

"It makes no sense that kids need parental permission to take aspirin at school, but they're free to buy and administer Plan B," Penny Nance, CEO and president of CWA, said in a statement.

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 it works best if taken in the first 24 hours.

The FDA had been poised to lift all age limits and let Plan B sell over-the-counter in late 2011, when 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 earlier this month that 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 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.

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.

Were you interviewed for this story? If so, please fill out our accuracy form

Send question/comment to the editors




Further Discussion

Here at PressHerald.com we value our readers and are committed to growing our community by encouraging you to add to the discussion. To ensure conscientious dialogue we have implemented a strict no-bullying policy. To participate, you must follow our Terms of Use.

Questions about the article? Add them below and we’ll try to answer them or do a follow-up post as soon as we can. Technical problems? Email them to us with an exact description of the problem. Make sure to include:
Most…