FDA Approves 'Morning-After Pill' for Girls 15 And Older

Megan Brooks

April 30, 2013

US health regulators today approved the emergency oral contraceptive Plan B One-Step (Teva Women's Health, Inc) for sale without a prescription to girls aged 15 years and older. The active ingredient in Plan B is levonorgestrel.

In a statement, the US Food and Drug Administration (FDA) said Plan B will now be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified."

"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. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft," the FDA said.

Teva will make the product available in retail outlets with an on-site pharmacy, where it generally will be available in the family-planning or female health aisles.

Plan B One-Step — also known as the morning-after pill — 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. Plan B One-Step is a single-dose pill (1.5-mg tablet). It is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 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, the FDA said.

"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, in the release.

"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," she added. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a healthcare provider, the FDA said.

Teva said it will educate consumers, pharmacy staff, and healthcare professionals about the product's new status. It has also indicated its willingness to conduct an audit of the age-verification practices after the product is approved to ensure that the age limitation is being followed.

Early in April, as reported by Medscape Medical News , a federal judge ordered the FDA to make Plan B One-Step available to all adolescent girls without a prescription within 30 days.

The FDA today said approval of Teva's amended application for Plan B One-Step is "independent of that litigation and this decision is not intended to address the judge's ruling."

"The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older," the agency said.

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