Food and Drug Administration

Center for Drug Evaluation and Research


Nonprescription Drugs Advisory Committee


Holiday Inn – Versailles Ballroom

8120 Wisconsin Avenue

Bethesda, Maryland 


Agenda                                                                                                 June 12, 2003


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


                    Introduction of Committee


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

                                                                                                            Executive Secretary


Continued Over-the-Counter (OTC) Status of Ipecac Syrup


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

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


                    Ipecac Syrup: Regulatory History                                Arlene H. Solbeck, M.S.

                                                                                                            Interdisciplinary Scientist, DOTCDP, FDA


8:30            Syrup of Ipecac: OTC or not OTC?                             Milton Tenenbein, M.D.                                                                                       

                                                                                                          University of Manitoba, Children’s Hospital                                                                


9:15            A Review of Ipecac Syrup                                             Anthony S. Manoguerra, Pharm.D.

                                                                                                            California Poison Control System

                                                                                                            University of California, San Diego


10:00          Break


10:15          Syrup of Ipecac - One Advocate's Perspective           William O. Robertson, M.D.                      

                                                                                                            Washington Poison Center


11:00          Ipecac Abuse                                                                  Tomas Jose Silber, M.D.                                                                                                           

                                                                                                            Children’s National Medical Center


11:45          Questions from the Committee


12:00          Lunch


1:00            Open Public Hearing                                                 


2:00            Committee Discussion


                    Questions to the Committee


3:00            Break


4:30            Adjourn