 FDA NEWS RELEASE 
 
 For Immediate Release: April 30, 2013 
 
 Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov 
 
 Consumer Inquiries: 888-INFO-FDA 
 
 FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older 
 
 The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older. After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription. "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 Hamburg in a statement. “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.” 
 
 
 
 The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. On April 5, 2013, a federal judge in New York ordered the FDA to grant a 2001 citizen’s petition to the agency that sought to allow over-the-counter access to Plan B (a two dose levonorgestrel product) for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions. A panel of scientists at the FDA had recommended in 2011 that age restrictions be lifted on the morning-after pill, but Secretary of Health and Human Services Kathleen Sebelius overruled that recommendation, arguing that there was a lack of evidence showing that those under the age of 17 would use the pill appropriately.
– The Plan B morning-after pill is moving over the counter. The FDA announced today that the emergency contraceptive will be available without a prescription to those ages 15 and older. The pill also no longer needs to be behind pharmacy counters. Instead, it can sit on drugstore shelves just like condoms, but buyers will have to prove their age at the cash register. Earlier this month, a federal judge ruled there should be no age restrictions and gave the FDA 30 days to act. The FDA said that its latest decision was independent of the court case, and that Justice Department lawyers were still considering their response to the ruling. "Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," says FDA chief Margaret Hamburg. "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." Click for more.