Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual

In April 2003, Women's Capital Corporation submitted an application to the Food and Drug Administration (FDA) requesting the marketing status of its Emergency Contraceptive Pill (ECP), Plan B, be switched from prescription to Over-The-Counter (OTC). This paper examines how the decision was made to not approve the switch of Plan B from prescription to OTC, how the Plan B decision compares to the decisions for other proposed prescription-to-OTC switches from 1994 through 2004, and whether there are age-related marketing restrictions for prescription Plan B and other prescription and OTC contraceptives.

Provided by: U.S. General Accounting Office Topic: Software Date Added: Nov 2005 Format: PDF

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