Plan B Ruling: Little Commercial Impact, Big Policy Implications
This article was originally published in The Tan Sheet
Executive Summary
The court ruling overturning FDA's restricted distribution of the emergency contraceptive Plan B could have a number of implications for the biopharma industry - ranging from a near-term impact on confirmation of Obama administration nominees to a longer-term curbing of creative product risk management activities
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Updated Plan B Lawsuit Could Expand Emergency Contraceptive Switch Targets
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.
Updated Plan B Lawsuit Could Expand Emergency Contraceptive Switch Targets
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.
FDA Will Wait To Act On Plan B Petition Despite Contempt Complaint
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.
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