Despite Court Order to Make EC Available for Women of All Ages, FDA Approves Plan B One-Step Only for Women 15 Years Old and Older
New drug approval only applies to one brand of emergency contraception, ignores clear and challenging barriers for women of all ages
04.30.13 - (PRESS RELEASE)Today the U.S. Food and Drug Administration has approved Plan B One-Step to be sold over-the-counter and without a prescription to women ages 15 and up, lowering the age restriction by two years for only one brand of emergency contraception.
On April 5, U.S. District Court Judge Edward Korman ordered the U.S. Food and Drug Administration make levonorgestrel-based emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days. The ruling was in response to the Center for Reproductive Rights' renewed lawsuit against the agency to expand over-the counter access to the morning-after pill, such as Plan B One-Step or Next Choice, to women of all ages.
Said Nancy Northup, president and CEO of the Center for Reproductive Rights:
"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday.
“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women—but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend.
“These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."
In his 59-page decision, Judge Korman specifically called out the government’s stalling tactics, noting the “FDA has engaged in intolerable delays” amounting to an “administration agency filibuster.”
The Center filed Tummino v. Hamburg along with Andrea Costello of the Partnership for Civil Justice Fund and Kirsten Clanton of Southern Legal Counsel on behalf of grassroots feminist activists with National Women's Liberation and 15-year-old Anaya Kelly. The Center also represents the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and parents who seek over-the-counter access for their daughters in the case.