The U.S. Food and Drug Administration was set to grant permission for the emergency contraceptive Plan B One-Step® to be sold over the counter for anyone of reproductive age. Unfortunately, Secretary of Health and Human Services Kathleen Sebelius intervened at the last minute to stop that action.
Below are answers to some key questions about this decision.
Q: What is emergency contraception?
A: Emergency contraception is back-up birth control that can be taken after sex to prevent pregnancy. It can be taken up to three days, and sometimes up to five days, after unprotected sex or contraceptive failure and still be effective. But the earlier it is taken, the more effective it is.
Q: Is emergency contraception the same as the abortion pill?
A: No. Emergency contraception prevents pregnancy and works much like the birth control pill. If a woman is already pregnant, it will not work. The “abortion pill” (mifepristone or RU-486), in contrast, terminates an early but already established pregnancy.
Q: What does it mean for a drug to be available “over the counter?”
A: When a drug is available “over the counter,” it means it can be sold without a prescription on the pharmacy shelf, just like aspirin.
Q: Is it safe for emergency contraception to be sold without a prescription?
A: Yes, a panel of experts at the Food and Drug Administration found that it is both safe and effective for use by anyone of reproductive age.
Q: Isn’t emergency contraception already available over the counter?
A: Emergency contraception is in a gray zone known as “dual labeling.” It is available behind the counter for women ages 17 and older, meaning that they do not need a prescription but they have to ask a pharmacist for the drug. Teens 16 and younger need a prescription in order to obtain it. The FDA was set to remove the age restriction, based on the scientific data before it, but Health and Human Services overruled the FDA decision.
Q: What is the effect of the age restriction on emergency contraception?
A: The age restriction creates barriers not just for teens but also for adult women. Women do not always know where to find emergency contraception, are embarrassed to ask for it, are told they need a prescription by pharmacists who do not understand the law, or are turned away by pharmacists who disapprove of it. With emergency contraception, time is of the essence. A woman who fears she might become pregnant needs fast access, not delays at the pharmacy counter.
Q: Should teens be allowed to have unrestricted access to emergency contraception?
A: Whether we like it or not, almost half of teens in high school report having sex. They need to have all options available to them to protect themselves from unintended pregnancy, including routine contraceptive use before sex and emergency contraception as a back-up method if something goes wrong. Experts agree that anyone of reproductive age can safely use emergency contraception without a prescription.
Q: What is the significance of the administration’s decision?
A: Removing the unnecessary age restriction would have allowed anyone of reproductive age to be able to find Plan B One-Step® on the shelf without delay, confusion, or embarrassment. But instead, the needless barriers to preventing pregnancy after sex will remain in place and will only contribute to the United States having one of the highest unintended pregnancy rates in the industrialized world.
Jessica Arons is Director of the Women’s Health and Rights Program at the Center for American Progress.