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)
Call to Order and Opening Remarks Louis R. Cantilena, Jr., M.D., Ph.D.
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
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
Opening Remarks Sandra Kweder, M.D.
Deputy Director, Office of New Drugs, FDA
Introduction to the Issues Curtis Rosebraugh, M.D., M.P.H.
Deputy Director, Division of Over-the-Counter Drug Products, FDA
Sponsor Presentation Women’s Capitol Corporation
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.
Director, Obstetrics and Gynecology
University of California-Irvine Medical Center
Clinical Trials Carole Ben-Maimon, M.D.
Health Consequences of Plan B OTC David Grimes, M.D.
Vice President of Biomedical Affairs
Family Health International
Department of Obstetrics and Gynecology
CARESM Program Carole Ben-Maimon, M.D.
Questions to the Sponsor from the Committee
Safety Review Daniel Davis, M.D.
Division of Reproductive and Urologic
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.
Division of Over-the-Counter Drug Products
Questions to the FDA from the Committee
Open Public Hearing
Questions to the Committee