The FDA has approved the use of the emergency contraception Plan B One-Step for women ages 15 and older without a prescription.
This decision was announced today. The FDA’s move was in response to an amended application by Plan B maker Teva Women’s Health Inc. Earlier this month, a federal judge ordered the FDA to make Plan B, commonly referred to as the “morning after pill”, available to all women of reproductive age. The FDA says today’s ruling is not related to the judge’s orders.
"The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling," an FDA official said.
Today’s decision reverses a 2011 ruling from the FDA that restricted Plan B to women ages 17 and older. FDA commissioner Dr. Margaret Hamburg said the new ruling is based on scientific evidence that shows the emergency contraceptive can effectively reduce unwanted pregnancy rates in any age group.
“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,” Hamburg said.
Officials from the Department of Justice are still considering whether to appeal or uphold the separate decision made by Judge Edward Korman earlier this month that would make Plan B available to any woman who wants the contraceptive regardless of age.
The FDA’s failure to address Judge Korman’s ruling was criticized by some, including the Center for Reproductive Rights President Nancy Northup.
“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women,” she said. “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.”
Plan B, along with generic versions of the drug, uses Levonorgestrel to reduce the possibility of becoming pregnant when taken within 2-3 days of unprotected intercourse. The drug, which has at times been criticized by anti-abortion advocates, is not capable of ending a pregnancy if a woman has already become pregnant.