Updated Plan B Lawsuit Could Expand Emergency Contraceptive Switch Targets
This article was originally published in The Pink Sheet Daily
The Center for Reproductive Rights plans to revise its 2005 complaint against FDA seeking OTC access to emergency contraceptives. In addition to adding HHS Secretary Sebelius as a defendant, CRR may ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.
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HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.
FDA does not plan to look at allowing wider access to nonprescription emergency contraceptive Plan B until Teva Pharmaceuticals files an application, despite a complaint accusing the agency of ignoring a court order to reconsider age restrictions on the product.
Teva Pharmaceutical Industries likely will gain another three years of exclusivity in the branded nonprescription emergency contraceptive market with FDA's approval of a revised dosage of Plan B