Joint session of the

Nonprescription Drugs Advisory Committee

and the

Advisory Committee for

Reproductive Health Drugs


December 16, 2003


NDA 21-045 - proposing over-the-counter (OTC) use of Plan B (levonorgestrel)





Tab 1 Meeting Agenda, including Discussion Points to Consider


Tab 2 Review of the Plan B OTC Label Comprehension Study


      Review from the Division of Surveillance, Research and Communication Support

      Medical Officer Review


Tab 3 Review of the Actual Use Study

      Executive Summary

      Summary of Results of Actual Use of Low Comprehension Concepts from the Label Comprehension Study

      Plan B OTC Actual Use Study


Tab 4 Review of Behavior Study Literature


      Sexual and Contraceptive Behavior Studies on Plan B


Tab 5 Plan B Safety Review


      Medical Officer Review

      Office of Drug Safety, Division of Drug Risk Evaluation Review

      Review of Teratogenic Risk of Hormonal Products for Contraception


Tab 6 Draft Label


Tab 7 (to be distributed the first week of December)

Overview of existing and potential non-prescription distribution mechanisms