By Dawn Cranfield
FDA – Plan B Available to Over the Counter to Girls as Young as 15
The Food and Drug Administration (FDA) announced today that it has approved a revised application by Teva Women’s Health, Inc. to market and sell Plan B One-Step without a prescription to women and girls age 15 years of age and older.
The oft-controversial product, Plan B One-Step, is contraceptive intended to be used in emergency situations following intercourse when another form of birth control was not used or failed (e.g. condom). It is a single-dose table (1.5 mg) that has the most desired effect, preventing pregnancy, if taken immediately or within 3 days of the sexual contact.
The Plan B One-Step pill does not terminate an already developing pregnancy, and there is currently no medical evidence substantiating any harm to an already developing fetus. Previously, in December 2011, the FDA failed to approve Plan B One-Step for over-the-counter sales to all females of reproductive age, so Teva resubmitted with a compromised age of 15.
As a result of the compromise, the emergency contraception will now come with a label requiring cashiers to verify proof of age. Customers who are unable to provide proof either by valid driver’s
license, state or school issued identification, passport, or birth certificate will be denied the purchase. To prevent theft of the drug, Teva will place security tags on the product cartons.
“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.” (fda.gov)
Some of the controversy over what has been dubbed the “morning after” pill may be confusion over the whether it is an “abortion” method or a contraceptive; according to the “Frequently Asked Questions” on Plan B One-Step’s website,
“Plan B One-Step® is one pill that has a higher dose of levonorgestrel, a hormone found in many birth control pills that healthcare professionals have been prescribing for several decades. Plan B One-Step® works in a similar way to help prevent pregnancy from happening. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B One-Step® may also work by preventing fertilization of an egg (the uniting of the sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).” (planbonestep.com)
Customers who wish to purchase the over-the-counter contraception will be able to buy it in regular retail outlets as well as those stores with pharmacies but will be able to get it whether the pharmacy is open or closed. The product will be available alongside other family planning and
female health items.
The FDA and makers of Plan B One-Step want women and girls to understand that the product will not protect them from HIV, Aids, or other sexually transmitted diseases. They encourage sexually active individuals to have regular screenings and to discuss questions and concerns with their healthcare professionals.
Plan B One-Step is one of three emergency contraceptives currently marketed in the United States; Plan B and ella are the other two.
Plan B One-Source Drug Website