Updated Plan B Lawsuit Could Expand EC Switch Targets
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
Revised Suit Seeks Full OTC Status For Plan B One-Step And Generics
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.
Revised Suit Seeks Full OTC Status For Plan B One-Step And Generics
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.
Plan B Decision May Offer FDA Best Political Protection Available
Assuming that sexually charged products such as Teva’s emergency contraceptive remain subject to political decision-making, the explicit heavy hand of the HHS secretary in the OTC switch ruling may be the best approach for FDA and the Rx industry, especially considering the alternatives.