Full OTC Status For Two-Dose Emergency Contraceptives – Appellate Court
This article was originally published in The Tan Sheet
Unrestricted OTC sales of generic versions of the original two-dose Plan B emergency contraceptive must be allowed immediately, according to a June 5 appellate court order.
The U.S. Court of Appeals for the Second Circuit denied the Department of Justice’s motion for a stay of the district court order directing FDA to approve a citizen petition that sought full OTC availability of all levonorgestrel-based emergency contraceptives (Also see "In Brief" - Pink Sheet, 3 Jun, 2013.).
However, the appellate court delineated the two-dose (0.75-mg) product from Teva Women's Health Inc.’s Plan B One-Step, opting to grant the government’s request for a stay of the lower court’s order, pending appeal, as relates only to the single-dose (1.5-mg) product, which did not exist when the citizen petition originally was submitted to FDA in 2001.
This raises the possibility of a confusing scenario in which generic two-dose levonorgestrel products are sold at retail to consumers of all ages, while Plan B One-Step is similarly shelved as an OTC but restricted to consumers aged 15 years and older, per FDA’s recent approval of Teva’s supplemental new drug application.
Further, private-label equivalents to Plan B One-Step, such as Allergan PLC’s Next Choice One Dose, would remain behind the pharmacy counter, available nonprescription to consumers aged 17 and up, until Teva loses market exclusivity in 2016 (Also see "Plan B One-Step Goes OTC, With Three-Year Exclusivity, Lower Age Limit" - Pink Sheet, 6 May, 2013.).
For now, reproductive health advocates who had sued FDA over OTC access to emergency contraception, celebrated another apparent milestone – though DoJ has the option of appealing the denied portion of its motion for a stay.
“Finally, after more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous, and medically unnecessary restrictions to get emergency contraception,” said Nancy Northup, CEO of the Center for Reproductive Rights, in a statement.
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