FDA Approves Sale Of "Morning After" Pill For Women 15 And Older Without Prescription

The “morning after” pill Plan B One-Step is now available to women 15 years of age and older without a prescription, the Food and Drug Administration announced Tuesday.

According to a press release issued by the agency, the product 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.”

Furthermore, the FDA reported that the Teva Women’s Health Inc. has arranged to have a security tag placed on all product cartons in order to prevent against theft.

Furthermore, Teva will make the product available in retail outlets with an on-site pharmacy where it will generally be available in the family planning or female health aisles throughout the retailer’s hours, whether or not the pharmacy is open.

“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, M.D. 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 sexually transmitted disease.”

In addition to indicating that it plans to educate consumers, pharmacy staff and health care professionals about the product’s new status, Teva has also expressed willingness to conduct an audit on the age verification practices after the product’s approval in order to ensure that the age limitation is being followed, according to the FDA release.

The move is seen partly in response to a New York federal judge’s April 5 order that the FDA grant a 2001 citizen’s petition to the agency seeking the allowance of over-the-counter access to Plan B for women of all ages and/or the sale of the drug without age or point of sale restrictions.

However, according to the FDA, Teva’s application to market Plan B One-Step for women 15 and older was pending with the agency prior to the ruling.