Revised Suit Seeks Full OTC Status For Plan B One-Step And Generics
This article was originally published in The Tan Sheet
The Center for Reproductive Rights amends its suit against FDA to compel universal OTC access to levonorgestrel emergency contraceptives. The advocacy group adds HHS Secretary Kathleen Sebelius as a defendant after her recent decision to overrule FDA’s approval of OTC sales for Plan B One-Step.
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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 likely will ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.
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.
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