COMMITTEE ON ADOLESCENCE
This is an addendum to the American Academy of Pediatrics Policy Statement “Emergency Contraception” (Pediatrics 2012;130(6):1174–1182).
In April 2013, Judge Edward Korman of the US District Court of Eastern New York directed the Food and Drug Administration (FDA) to lift the ban on over-the-counter availability of levonorgestrel-based emergency contraceptives without a prescription and without point-of-sale or age restrictions. In June 2013, the Obama administration withdrew its appeal to the Korman ruling, and the FDA allowed the 1-pill formulation Plan B One-Step (Teva Women’s Health Inc, Frazer, PA) to be made available on the shelf without age restriction in the United States. The FDA granted Plan B One-Step 3 years of exclusive rights to sell the product without an age restriction. One-pill generic versions will likely be allowed to be sold on the shelf next to Plan B One-Step, but these products will require age verification and will not be sold to those younger than 17 years without a prescription. The 2-pill formulations of levonorgestrel-based emergency contraceptives will remain behind the pharmacy counter and will also not be sold to those younger than 17 years without a prescription.
- Copyright © 2014 by the American Academy of Pediatrics