Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Silver Spring Holiday Inn, 8777 Georgia Avenue, Silver Spring , MD



  March 4, 2003

Safety Update, tnf a blocking agents


9:00:  Call to Order and Introductions:  Steven B. Abramson,, M.D., Acting Chair 

            Meeting Statement:  Kathleen Reedy, Executive Secretary


9:10:  Introduction to the Topic and Background:  Jeffrey N. Siegel, M.D., FDA

            Safety Information: tuberculosis, lymphoma:   Li Liang, M.D., FDA

                                                  lymphoma, hepatic toxicity:  Tim Cote, M.D., FDA

                                                  congestive heart failure:  Ellis Unger, M.D., FDA


10:30: Break


10:45:  Abbott Laboratories: James Lefkowith, MD

      Steven Fischkoff, MD

      Robert Tarone, PhD


11:30: Amgen Incorporated:  Daniel Burge, M.D.

      Alan Silman, M.D.


12:15:  Centocor Incorporated:  Jerome A. Boscia, M.D.

                                                            Thomas F. Schaible, Ph.D.


1:00:  Open Public Hearing


1:30:   Lunch


2:30:  Introduction to Questions: Jeffrey N. Siegel, M.D., FDA

            Discussion and questions


3:45:  Break


5:00:  Adjourn