Girls as young as 15 will now be able to buy the morning-after pill, although packages will have a product code to prompt cashiers to verify the customer’s age. Anyone who cannot provide proof of age will not be allowed to complete their purchase, according to new rules released yesterday by the FDA.
Up until now, only those 17 and older were permitted to buy Plan Be One-Step emergency contraceptive, which were kept behind pharmacy counters without a prescription. Not only does the new ruling lower the age for consumers, it now allows the pills to be placed out in the open on drugstore shelves next to spermicides and condoms.
“This decision is a step in the right direction for increased access to a product that is safe and effective in preventing unplanned pregnancy, and moves us closer to these critical availability decisions being based on science not politics,” exclaimed Washington State Senator Patty Murray (D).
The move comes just weeks after a federal judge in Brooklyn, New York, ordered the FDA to make the morning-after birth control pill available to women of any age, without a prescription. Tuesday’s FDA announcement, which pertains to an application from Teva Women’s Health, Inc., is not related to that, the FDA said.
“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” the FDA said in a statement.
It should also be noted that the FDA decision does not pertain to the two other emergency contraceptive drugs marketed in the United States. Another drug, Ella, is available by prescription only, for all ages, and prevents pregnancy within five days of unprotected sex or contraceptive failure.
Plan B was first approved by the FDA in 1999 as an emergency contraceptive intended for use within 72 hours after sex in order to stop the egg from being released from the ovary, or preventing fertilization of the of the egg by sperm. However, it is best taken within 24 hours. If there has been fertilization, Plan B may prevent a fertilized egg from embedding in the uterus. But if the egg has already been implanted in the uterus, the morning-after pill will not work.
The key ingredient in Plan B is a synthetic hormone called levonorgestrel. The drug does not protect against sexually transmitted diseases, and those who engage in sexual intercourse are encouraged to use condoms if they do not want to become pregnant.
The morning-after pill sells for about $50, said Susannah Baruch, interim president and CEO of Reproductive Health Technologies Project.