Washington D.C. – On April 30, the Food and Drug Administration
approved over the counter sale of the morning-after pill Plan B One-Step to all women aged 15 and older.
Plan B One-Step is the name of the drug, made exclusively by Teva Women's Health, Inc., which acts as an emergency contraceptive which reduces the possibility of pregnancy when taken up to three days after sexual intercourse. It is taken as a single-dose 1.5 mg tablet of levonorgestrel.
Pharmacies and retailers with on-site pharmacies will have the drug on shelves, and those wishing to purchase it will have to provide proof of age. Teva has agreed to have a security tag placed on all Plan B One-Step cartons to prevent theft, according to the FDA.
Plan B is the same drug – levonorgestrel
– as Plan B One-Step, but is taken in two doses of 0.75 mg per tablet. Plan B, which is available from generic manufacturers, requires a prescription for women under the age of 17.
Ella, another emergency contraceptive, is prescription-only.
In Dec. 2011, Health and Human Services
secretary Kathleen Sebelius
overruled the FDA’s plan to make the morning-after pill available over the counter and with no age limits citing “significant cognitive and behavioral differences” between older adolescent girls and the youngest girls of reproductive age.
Today's release claimed that a study submitted by Teva showed that women 15 years and older are able to understand the drug is not for routine use and does not protect against sexually transmitted diseases.
On April 5, a federal judge in Brooklyn, Edward Korman, had ordered the FDA to allow over the counter sale of Plan B to women of all ages, and/or make Plan B One-Step available without age restrictions.
The FDA said that today's approval of Plan B One-Step is independent of Korman's ruling, which caused outcry last month from pro-life and Catholic groups nationwide over perceived health risks to young women.