FDA approves OTC Plan B One-Step for ages 15 and older

May 1, 2013

Last month's judicial ruling that all women of any age have non-Rx access to the drug remains an issue

Women who are 15 years and older will have access to emergency contraceptive Plan B One-Step (levonorgestrel) as an over-the-counter (OTC) medication that will no longer be sold behind the counter, according to the FDA.

On April 30, FDA approved the amended application for the emergency contraceptive that was submitted by its manufacturer, Teva Women’s Health Inc. Teva had previously asked FDA to make Plan B One-Step available OTC for all women of reproductive age, but FDA rejected that application in December 2011.

Yesterday’s FDA approval of the Plan B One-Step without a prescription for women 15 years and older is based on an actual use study and label comprehension data submitted by the manufacturer, demonstrating that women as young as 15 understood that the product was not for routine use and would not protect against sexually-transmitted diseases. The data indicated that proper use of the product was possible in this age group without consultation with a healthcare professional.

“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.”

Earlier last month, a New York federal judge ordered that the FDA grant a citizen’s petition to the agency that requested OTC access to Plan B (a two-dose levonorgestrel product) for women of all ages and/or access to Plan B without age or point-of-sale restrictions.

FDA’s approval of the current application for Plan B One-Step was not intended to deal with the litigation of the citizen’s petition, but was an independent decision, according to FDA.

The approval of Teva’s application for Plan B One-Step does not affect the prescription status of two other emergency contraceptives -Plan B (two-dose levonorgestrel product), which requires a prescription for women younger than 17 years or Ella (ulipristal), which is available only by prescription.