FDA Approves “Morning-After Pill” for Teenage Girls

Plan B One-Step—with the active ingredient being 1.5 mg levonorgestrel—is intended to reduce the possibility of pregnancy following unprotected sexual intercourse, if another form of birth control such as a condom was not used or failed. The single-dose pill is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse; it will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.

Manufactured by Teva Women’s Health, a subsidiary of Teva Pharmaceuticals (Petah Tikva, Israel), Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer's age. A customer who cannot provide age verification will not be able to purchase the product. Teva will also place a security tag on all product cartons to prevent theft. The product will be available in retail outlets with an on-site pharmacy, generally located in the family planning or female health aisles.

“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, MD. “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.”

The approval follows an order by senior US District Judge Edward Korman in April 2013 that required the FDA to make Plan B One-Step available to all adolescent girls without a prescription within 30 days. The FDA claims, however, that it took action independent of that litigation to approve the pending application on Plan B One-Step only for women 15 years of age or older, and not by all girls of reproductive age.

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US Food and Drug Administration
Teva Pharmaceuticals