Teva Women's Health, Inc. had previously made an application for Plan B One-Step to be available for sale over the counter, without the need of a prescription, to all women (of any age) last year, but the FDA did not approve it.
Plan B One-Step was approved by the FDA in 2009.
The company then decided to amend their application to make it available over the counter strictly for women 15 years of age and older. This new, amended application, did receive approval.
In order to ensure that the pills aren't sold to any girls younger than 15, the product will include the following labeling "not for sale to those under 15 years of age *proof of age required*, not for sale where age cannot be verified."
Cashiers, pharmacists and shop-assistants will be required to ask for the customer's age.
Plan B One-Step will be widely available as the company says it will distribute the pills to many retail outlets that have an onsite pharmacy, where they expect it to be sold in the family planning area. This way the contraceptive will be available during the retailer's operating hours regardless of whether or not the pharmacy is open.
Plan B One-Step is intended to be used as an emergency contraceptive, only in cases where the primary birth control (such as a condom) appeared not to have been effective. It will be available as a single 1.5 mg tablet to be taken within three days of having unprotected sex.
If a woman is already pregnant and takes Plan B One-Step it will not stop the pregnancy and there is no evidence of it harming a developing fetus.
The FDA Commissioner Margaret A. Hamburg, M.D., 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.
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 FDA approved Plan B One-Step without a prescription solely for women 15 years or older because of evidence suggesting that women of that age are likely to understand the product is not intended to be used on a routine basis and that it doesn't protect against sexually transmitted diseases.
It's especially important that women continually check for HIV or AIDS or other sexually-transmitted diseases and seek guidance for the best form of birth control.
The FDA stresses that emergency contraceptives such as Plan B One-Step aren't to be used on a routine basis.
To ensure that the age limitation is adhered to, Teva has said that it's willing to conduct an audit of age verification practices after the product has been approved.
A federal judge, in early April this year ordered the Agency to grant a 2001 citizen's petition that wanted OTC access to PLAN B legalized for women of all ages, and/or make Plan B One-Step available as an OTC medication with no restrictions on either age or point of sale. Teva's application to market PlanB One-Step for females aged 15+ years had been pending before the federal judge's ruling.
Written by Joseph Nordqvist