Morning-after Pill for Age 15 and Up Approved

by Sheela Philomena on May 2 2013 11:54 AM

 Morning-after Pill for Age 15 and Up Approved
US regulators have approved Plan B One-Step, a brand of emergency contraception for those age 15 and up without a prescription.
The decision by the US Food and Drug Administration to allow Plan B One-Step to be sold over the counter to some teens without a doctor's order did not go as far as a federal judge directed last month after a more than decade-long court fight.

"The product will now be labeled 'not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified,'" the FDA said in a statement late Tuesday.

Until now, emergency contraception has been available by prescription only to those under 17, and was for sale only behind pharmacy counters.

In April, US District Court Judge Edward Korman ruled that a 2011 decision by the chief of US Health and Human Services to require teens under 17 to obtain a prescription was "politically motivated" and "scientifically unjustified."

FDA Commissioner Margaret Hamburg said the latest decision was based on a review of data submitted by the Pennsylvania-based pharmaceutical company Teva showed that women age 15 and older were able to understand how it works without the intervention of a health care provider.

"The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease," she said in a statement.

The ruling applies to only one brand of emergency contraception, and requires that it be security-tagged to avoid theft and only sold over the counter in stores that have a pharmacy.

Nancy Northup, president and CEO of the Center for Reproductive Rights, said the FDA's ruling does not go far enough and vowed to press on with the legal effort to make all brands of emergency contraception readily available.

"Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women. But it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend," she said.

"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."

Levonorgestrel-based emergency contraception contains the same active ingredients as birth control pills but at higher doses, and may prevent pregnancy if taken within 72 hours after unprotected intercourse.


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