Food and Drug Administration

Center for Drug Evaluation and Research


Nonprescription Drugs Advisory Committee (NDAC)

 in joint session with the

Advisory Committee for Reproductive Heath Drugs (ACRHD)


Hilton, 620 Perry Parkway, Gaithersburg, Maryland 


Agenda                                                                                                          December 16, 2003


8:00             Call to Order and Opening Remarks Louis R. Cantilena, Jr., M.D., Ph.D.

                                                                                                            Chair, NDAC

                    Introduction of Committee


                    Conflict of Interest Statement                                              Karen M. Templeton-Somers, Ph.D.

                                                                                                            Executive Secretary, NDAC


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

Women’s Capitol Corporation, for reducing the chance of pregnancy after unprotected sex


8:10             Opening Remarks                                                            Sandra Kweder, M.D.

                                                                                                            Deputy Director, Office of New Drugs, FDA          


8:15             Introduction to the Issues                                                Curtis Rosebraugh, M.D., M.P.H.

Deputy Director, Division of Over-the-Counter Drug Products, FDA


8:30             Sponsor Presentation                                                       Women’s Capitol Corporation

                                                                                                            Barr Research 


Background Review                                                           Carole Ben-Maimon, M.D.

How Plan B Works                                                                        President and Chief Operating Officer

                    Rationale for OTC Switch                                                   Barr Research


ACOG Presentation                                                            Vivian Dickerson, M.D.

American College of Obstetricians and Gynecologists 

Director, Obstetrics and Gynecology

University of California-Irvine Medical Center


Clinical Trials                                                                     Carole Ben-Maimon, M.D.

Label Comprehension

Actual Use


Health Consequences of Plan B OTC                                  David Grimes, M.D.

                                                                                        Vice President of Biomedical Affairs

Family Health International

Department of Obstetrics and Gynecology

University of North Carolina School of Medicine


CARESM Program                                                               Carole Ben-Maimon, M.D.   


9:30              Questions to the Sponsor from the Committee


9:45             Break



10:00            FDA Presentation


                    Safety Review                                                                   Daniel Davis, M.D.

                                                                                                            Medical Officer

                                                                                                            Division of Reproductive and Urologic

                                                                                                                        Drug Products


                    Plan B Label Comprehension Study                                     Karen Lechter, J.D., Ph.D.

Social Science Analyst

Division of Surveillance, Research and Communication Support

                                                                                                            Office of Drug Safety


                    Plan B Actual Use and Behavior Studies                              Jin Chen, M.D., Ph.D.

                                                                                                            Medical Officer

                                                                                                            Division of Over-the-Counter Drug Products


10:50            Questions to the FDA from the Committee


11:00            Open Public Hearing                   


12:30            Lunch


1:30             Committee Discussion


                    Questions to the Committee


3:30             Break


5:00             Adjourn