FDA Approves OTC Plan B for Women 15 Years and Up

The US Food and Drug Administration (FDA) announced that it has approved an application submitted by Teva Women’s Health to market the emergency contraceptive Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. In December 2011, Teva had submitted an application to make Plan B One-Step available over the counter (OTC) to all girls of reproductive age, however at that time the FDA did not approve the application.

This approval is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually transmitted diseases. The FDA stated that “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.” To prevent theft, a security tag will be placed on all product cartons of Plan B One-Step.

“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.”

Besides Plan B One-Step, there are currently two other emergency contraceptive drugs available in the United States: Plan B and ella. Plan B is a prescription contraceptive that is available from generic manufacturers for women over the age of 17. It is comprised of two doses of levonorgestrel (.75 mg in each tablet) taken 12 hours apart. Ella (ulipristal) also requires a prescription, and prevents pregnancy when taken orally within 5 days after unprotected sexual intercourse.

Plan B One-Step 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.