Plan B contraceptive approved by US regulator

After initially rejecting an application by the maker of the contraceptive Plan B One-Step to market the product to women and teenagers as young as 15 years of age without a prescription, the FDA has now approved it.
Plan B One-Step, made by Teva Pharmaceutical Industries based in Israel, will be available to all women of child-bearing age in retail outlets with an on-site pharmacy, the FDA said in a news release. Cashiers will have to verify the customer's age.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," said FDA Commissioner Margaret A Hamburg.
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 and how to use it properly, Hamburg said.
Also known as the morning-after pill, Plan B One-Step is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within three days after unprotected sexual intercourse, the FDA said.
The product will not end a pregnancy, and there is no medical evidence that it will harm a developing fetus if used by a pregnant woman. It will not protect a woman from HIV or AIDS or other sexually-transmitted diseases.
The announcement comes after a federal judge on April 5 ordered the FDA to make emergency contraception available nationwide without limits within 30 days. Plan B One-Step has been available in pharmacies to women 17 and older, but it was kept behind pharmacy counters.
Reproductive rights advocates said the announcement was an important step forward.
"This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it," Planned Parenthood, a health-care provider and advocacy group for reproductive rights, said in a statement.//DPA