Plan B Contraceptive Access Limits Spur New U.S. Court Action Against FDA
A reproductive rights group asked a federal judge to reopen a lawsuit over access to the emergency contraceptive Plan B, claiming the Food and Drug Administration acted in “bad faith” when it placed restrictions on the drug.
The Center for Reproductive Rights, in a filing today in federal court in Brooklyn, New York, said reopening its 2005 case was the most efficient way for the group to overturn the FDA’s age restraints on the drug. The group urged the court to order the agency to make Plan B available within 30 days without a prescription or age restrictions.
“The FDA has continually treated emergency contraception completely different than it has any other medication,” Suzanne Novak, senior staff attorney for the New York-based center, said in a statement. “We are asking the court to recognize that the FDA has failed to meet its obligation to the public and make decisions based on science, rather than politics.”
The group previously supported Teva Pharmaceutical Industries Ltd. (TEVA) in a failed bid to make an emergency contraceptive, Plan B One-Step, available in stores to all ages.
U.S. Secretary of Health and Human Services Kathleen Sebelius ordered the FDA to reject the application in December because of the “cognitive and behavioral” differences in girls of the youngest reproductive age. The reproductive rights group asked to add Sebelius as a defendant in the case.
“The administration’s decision to overturn the FDA was a huge mistake and I hope that the judge will review what the center has said and show us a path forward for fixing it,” said Amy Allina, a program director at the National Women’s Health Network in Washington, in an interview.
The pill and generics are now kept behind pharmacy counters and sold without prescription only to women 17 and older. Younger girls may obtain the drug with a doctor’s order. Plan B One-Step reduces pregnancy risk if taken within three days of sex.
Denise Bradley, a Teva spokeswoman, didn’t respond to requests for comment about whether the company supports the legal action.
“The department does not comment on pending litigation,” Erin Shields, a spokeswoman for the Health and Human Services Department, said in an e-mail.
Erica Jefferson, a spokeswoman with the FDA, didn’t immediately respond.
The Center for Reproductive Rights sued the FDA in 2005 for not acting on a request for over-the-counter sales. In 2006, the FDA granted Barr Pharmaceuticals Inc. permission to sell the pill without a prescription only to women 18 years of age or older. Teva, based in Petach Tikva, Israel, now owns Barr.
U.S. District Judge Edward Korman in Brooklyn, New York said in 2009 that the age restrictions were arbitrary and based more on political pressure than safety. He ordered the pill be made available without a prescription to 17-year-olds as well.
The judge also ordered the agency to reconsider whether to approve Plan B and generics sold on drugstore shelves without age restrictions.
The case is Tummino v. Hamburg, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).