Federal Judge Approves Government’s Plan to Make Plan B One-Step Available Without Restriction
(PRESS RELEASE) U.S. District Judge Edward Korman has approved the Obama Administration’s proposed plan to comply with a federal court order to lift longstanding restrictions that impede and delay women’s access to emergency contraception by making Plan B One-Step available over the counter without age or point of sale restrictions.
Upon approving the plan, Judge Korman recognized that the plan “obfuscates the true effect of the FDA’s grant of marketing exclusivity to Teva,” and confers “a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.”
Said Nancy Northup, president and CEO at the Center for Reproductive Rights:
“We are tremendously gratified that this lawsuit has resulted in an historic victory to bring emergency contraception out from behind the pharmacy counter for millions of women across the United States.
“We agree with Judge Korman that women deserve the full range of available emergency contraception, including lower cost generic options.
“We will continue our advocacy on all fronts to ensure widespread availability of affordable birth control for all women in the United States and beyond.”
Korman specifically cited the decade-long efforts of reproductive rights advocates in bringing about this landmark change:
“It is only because of the extraordinary efforts by the plaintiffs in pursuing their Citizen Petition that Teva is able to seek approval of an SNDA that will permit it to market its product with no point-of-sale or age restriction. Such approval, if given, will be nothing more than a reward to Teva for playing along with the defendants’ efforts to maintain their legally and scientifically unjustified restrictions on the marketing of levonorgestrel-based emergency contraceptives. It is the plaintiffs, rather than Teva, who are responsible for the outcome of this case, and it is they, and the women who benefitted from their efforts, who deserve to be rewarded.”
The Obama Administration appealed Korman’s decision on May 1, one day after the FDA approved an application from Plan B One-Step to be sold over-the-counter to women ages 15 and up—but only in stores that have an on-site pharmacy and if the woman can prove her age.
Last week, the U.S. 2nd Circuit Court of Appeals ordered the FDA to immediately comply with Judge Korman’s court order as it applied to two-pill versions of levonorgestrel-based emergency. However, the appellate court’s decision stayed Judge Korman’s order as it applies to one-pill products, such as Plan B One-Step, pending the outcome of the government’s appeal.
The Center reopened Tummino v. Hamburg in February 2012 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.