Plan B One-Step approved for use without a prescription for women 15 and older
The Food and Drug Administration approved the use of Plan B One-Step for women aged 15 and older without a prescription.
The decision, which was announced on Tuesday, was in regards to an amended application submitted by Teva Women's Health, Inc. The company first sought approval to market Plan B One-Step to all females of reproductive age, but changed their initial appeal for approval for those 15 and older.
Plan B One-Step, also known as the "morning after pill," is a form of emergency contraception that can reduce the chance of pregnancy after a person has engaged in unprotected sex, meaning they did not use another form of birth control or their chosen method did not work.
There are currently three types of emergency contraception available for sale in the U.S.: Plan B One-Step, Plan B, and ella. Plan B is a two-pill system that requires a prescription for those who are under 17. Ella also requires a prescription, regardless of age.
Plan B One-Step does not stop pregnancy if a woman is already pregnant, nor has any scientific evidence shown that it will harm a fetus that already exists. The single-dose pill works best if taken within three days after sexual intercourse.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," Dr. FDA Commissioner Margaret A. Hamburg, said in a press 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."
Plan B One-Step will now bear a label that reads "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified." The product code will prompt cashiers to ask for proof of age when a person attempts to purchase the product, and it will not be sold to anyone who cannot provide proof of their age.
Security tags will also be placed on the products to deter thieves. Plan B One-Step will be sold in retail outlets with an onsite pharmacy as part of the agreement, but it can be sold regardless if the pharmacy is open or not.
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The FDA considered actual use studies and label comprehension data submitted by Teva Women's Health, Inc. when making their decision. The agency determined that women 15 and older knew the product could not be used regularly and would not protect them from sexually transmitted diseases.
Earlier in April 2013, U.S. District Judge Edward Korman ordered that the FDA had to make contraceptives available to females of all ages, calling the requirement for a prescription "arbitrary, capricious and unreasonable." However, the pending request from Teva Women's Health, Inc. at that time only asked for the prescription ban to be lifted for women aged 15 or older.
"This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies," Senator Patty Murray, D-Wash., said in a statement to CBS News. "It's also a decision that moves us closer to these critical availability decisions being based on science, not politics. Plan B is an essential part of a woman's basic health care and I will continue to push for more information from FDA and HHS on the practical application of this policy while also working to ensure that access is based on science, safety, and efficacy."
