FDA approves ‘morning after pill’, Plan B One-Step for females 15 years of age and older without a script
In controversial move yesterday, the U.S. Food and Drug Administration (FDA) today an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
Plan B One-Step emergency contraceptive
Image/Video Screen Shot
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.” 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.
Specifically, teenagers below 15 would now need a prescription to purchase the product. That age was previously 17. The proposal would also allow the product to be sold on retail shelves, rather than behind the pharmacy counters, with age to be verified by cashiers rather than pharmacy staff.
NPR reports; however, the approval stops short of the full over-the-counter, no-age-restriction order issued April 5 by U.S. District Court Judge Edward Korman.
Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse – if another form of birth control (e.g., condom) was not used or failed. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse, according to the FDA.
“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. “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.”
Planned Parenthood Federation of America President Cecile Richards released the following statement yesterday after the FDA announcement:
“While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy. Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy.
“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine. As the nation’s leading provider of women’s health care, Planned Parenthood knows firsthand how critical it is that women be able to get emergency contraception quickly and without hurdles.”
However, not everyone is as enthusiastic about the FDA move as Planned Parenthood.
Lori Szala, Director of the Pregnancy Resource Center in Upper St. Claire, PA told WTAE-TV that the FDA decision is not appropriate for young women, “I can’t imagine a 15-year-old being mentally and emotionally prepared to make a medical decision like taking medication.”
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