The US Food and Drug Administration has approved over-the-counter use of levonorgestrel (Plan B), the morning-after emergency contraception pill, to women who can prove they are 18 or older.
OTC sales of levonorgestrel, which has been available by prescription since 1999, are anticipated before the end of the year nationally. The 2-pill pack costs from US$25 to $40. Nine states, Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont, already allow women of any age to buy levonorgestrel OTC from designated pharmacies.
According to the FDA approval announcement on Aug. 25, girls 17 and younger will still need a doctor's prescription (except in those states that specifically allow access at any age).
Levonorgestrel has been available OTC in Canada since April 2005 (CMAJ 2005;172[7]:86-7). Unlike Canada, US pharmacists will not provide counselling services when they sell the product.
The US approval caps a stormy 3-year debate in which medical organizations and women's rights groups argued that OTC status for levonorgestrel could cut the nation's annual 3 million unplanned pregnancies in half. Social conservative groups feared easier access for younger women would encourage promiscuity and increase sexually transmitted disease. Many also argued that imposing the 18-year-old limitation would be as ineffective as similar limitations on cigarettes and could be easily circumvented by 18 year olds buying the drugs for younger friends.
In applauding the FDA action, Amercian Medical Association Board member Dr. Joseph M. Heyman said “Plan B meets all of the customary criteria for OTC availability. This classification of the drug will increase women's access to emergency contraception and can prevent unwanted pregnancies.”
The American College of Obstetricians and Gynecologists (ACOG) also approved the action but faulted FDA on limiting the drug's access to women 18 or older. In a statement, ACOG noted: “By restricting its OTC availability to women age 18 and older, the FDA has missed an unparalleled opportunity to prevent teenage pregnancies. Each year there are more than 800 000 teen pregnancies in the US, with many ending in abortion. Pregnancy itself is not without risk, especially for a young woman.”
Drug manufacturer Barr Pharmaceuticals notes that levonorgestrel should be taken within 72 hours of unprotected sex, but that the sooner it is taken the more effective it will be. Barr says that if taken within 72 hours, levonorgestrel can reduce the risk of pregnancy by 89%.