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

CARE^SM 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