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.

                                                                                                            Chair

                    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