Teva Pharmaceutical Industries Ltd. (TEVA) sought to intervene in a lawsuit between the Center for Reproductive Rights and the U.S. government over emergency contraceptives, saying loosening sales restrictions on generics could threaten its marketing rights for Plan B One-Step.
Last month, U.S. District Judge Edward Korman in Brooklyn, New York, ordered the government to explain why he shouldn’t direct the Food and Drug Administration to make the drugs available to girls under age 17 without a prescription. Teva said in its filing today that loosening the age limits on over- the-counter sales of generic drugs similar to its own would threaten its three-year exclusivity period for unrestricted OTC sales.
Teva, based in Petach Tikva, Israel, earned that exclusivity by submitting a drug application “containing the clinical studies referenced in the court’s Feb. 16 show-cause order,” Teva wrote.
The FDA issued a ruling in December blocking unrestricted access to generic copies of the emergency contraceptive, affirming a move a week earlier requiring girls under age 17 to have a prescription for the brand-name drug. The Manhattan-based center had sued the agency, saying it failed to take up the issue.
Kate Bernyk, a spokeswoman for the Center for Reproductive Rights in New York, didn’t have an immediate comment on Teva’s filing.
The FDA originally said it would approve brand-name Plan B One-Step as the first over-the-counter emergency contraceptive. U.S. Secretary of Health and Human Services Kathleen Sebelius on Dec. 7 ordered FDA Commissioner Margaret Hamburg to reject Teva’s application to make the drug available to girls under 17 without a prescription. Sebelius’s intervention was the first time HHS overrode an FDA staff decision.
On Dec. 12, the FDA maintained its policy for two-dose generic versions from makers such as Watson Pharmaceuticals Inc. (WPI) of Parsippany, New Jersey, and Perrigo Co. (PRGO) of Allegan, Michigan.
“We conclude that FDA needs additional data to support a switch of Plan B for women under 17 years of age,” the agency wrote. “In the absence of such data, FDA declines to initiate a rulemaking to switch Plan B” to an over-the-counter product for those consumers.
Plan B One-Step and the generics are currently kept behind pharmacy counters and are 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. The original brand-name Plan B at issue in the lawsuit is no longer made.
Korman said at a December hearing there was no difference between the brand-name and generic drugs except the former requires one pill and the latter requires two.
In its filing, Teva said its interests aren’t aligned with either the center, which seeks to eliminate age restrictions on any of the drugs, or the government, which seeks to defend all such limits.
The case is Tummino v. Hamburg, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).
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