Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS105468

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel