FDA ANNOUNCES FRAMEWORK FOR GRANTING PLAN B OTC STATUS

FDA has announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B contraception as an OTC drug. The agency and the Duramed will discuss the proposed restricted distribution and risk management plan as part of the framework for potential approvability as a nonprescription product for women ages 18 and older. They have agreed to meet immediately to discuss the approvability of the amended application, and plan to have the process finished in a matter of weeks.

In the letter to Duramed, the FDA communicated its plan to work together in order to move Plan B from prescription only to OTC status for woman ages 18 and older. The FDA's primary concerns are to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use.