The U.S. Food and Drug Administration announced yesterday in a press release that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step, levonorgestrel, to girls 15 years of age or older.
“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.”
Teva applied to make Plan B One-Step available over-the-counter for all females of reproduction age in December of 2011. The FDA did not approve this application. Teva then submitted an amended application making the morning after pill available for girls aged 15 and older. Although the actual wording is ‘women 15 years of age and older,’ for no other purpose is a 15-year-old girl considered a woman.
The pill will be labeled ‘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 of the Plan B One-Step will prompt a cashier to request and verify the customer’s age. Any customer who can’t provide verification of age will not be able to purchase the product. Teva has also arranged to have a security tag on all product cartons to prevent theft.
According to the FDA, “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 goal of the pill is to decrease the rate of unintended pregnancies in the United States, says Commissioner Margaret A. Hamburg, M.D.
There are currently three emergency contraceptive drugs marketed in the United States – Plan B One-Step, Plan B, and ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (.75 mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal) is a prescription-only product that prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected sexual intercourse.
There are concerns that making the morning after pill available to young girls without a prescription may make it easier for rape to go unreported. There are still too many unknowns concerning the pill to say that it is safe for girls as young as 15.
No form of contraception should be used by girls as young as 15 without parental guidance. Girls this young may not understand how the contraception works or what the side effects may be, if any. Girls need to know that it is emergency contraception, not something to purchase after every incident of sexual encounter.
Parents need to be aware that unscrupulous men or boys may force or pressure their daughter to purchase the pill after having sex to prevent any possibility of being found out. At the very least, mothers should discuss this ‘without a prescription’ contraception with their daughters.