May 2, 2013
FDA Approves Morning After Pill For Ages 15 And Up
redOrbit Staff & Wire Reports - Your Universe Online
The Food and Drug Administration (FDA) approved on Tuesday the over-the-counter sale of morning-after pills for those 15 years of age and older, and will make the pills available on store shelves, rather than being sold from a pharmacy.
Until now, emergency contraception has been available by prescription only to those under the age of 17, and was only sold from behind pharmacy counters.
The FDA ruling, which takes effect immediately, applies to only one brand of emergency contraception — Plan B One-Step, made by Pennsylvania-based pharmaceutical company Teva — and requires that the product be security-tagged to avoid theft, and only be sold over-the-counter in stores that have a pharmacy.
The product will be packaged with a product code prompting a cashier to request and verify the customer´s age, and those who cannot provide age verification will not be able to complete the purchase.
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.
Plan B One-Step is a levonorgestrel-based emergency contraception pills that contains the same active ingredients as birth control pills, but at higher doses to prevent pregnancy when taken within 72 hours after unprotected intercourse.
Tuesday´s FDA ruling defies a judge's order to make the pills available to all girls and women of all ages. On April 5, US District Court Judge Edward Korman ruled that a 2011 decision by the head of the US Health and Human Services to require teens under the age of 17 to obtain a prescription for the pills was "politically motivated" and "scientifically unjustified.” Judge Korman´s ruling directed the FDA to make the pills available to all girls of reproductive age without a prescription within 30 days.
On Wednesday, the Justice department filed a formal appeal of that court order with the 2nd US Circuit Court of Appeals in New York, according to court documents.
According to Terry Baynes of Reuters, FDA spokeswoman Erica Jefferson said DoJ lawyers have asked the court to temporarily halt its order from taking effect while the appeal is pending.
FDA Commissioner Margaret Hamburg said the drug agency´s current decision to allow the morning after pills to be sold over-the-counter to 15 year olds was based on a review of data submitted by the Teva, which showed that girls and women aged 15 and older were able to understand how the pill works without the assistance 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 the FDA statement.
The appeals case is Tummino et al. v. Hamburg et al., U.S. District Court for the Eastern District of New York, No. 12-763.