Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD

Agenda

August 17, 2001

Safety Updates:

Enbrel Ô (etanercept), Immunex,

RemicadeÔ (infliximab) Centocor

10:00 Call to Order and Introductions: H. James Williams, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

10:15 FDA, CBER Presentation:

Objectives: William D. Schwieterman, M.D., Branch Chief

MedWatch Adverse Event Data: Value & Limitations: M. Miles Braun, M.D., M.P.H.

Director, Division of Epidemiology, Office of Biostatistics and Epidemiology

Safety Data: Jong-Hoon Lee, M.D., Medical Reviewer

Division of Epidemiology, Office of Biostatistics and Epidemiology Jeffrey N. Siegel, M.D., Medical Reviewer

Division of Clinical Trial Design and Analysis

Office of Therapeutics Research and Review

11:15 Open Public Hearing

11:45 Immunex Presentation:

Etanercept Post-Marketing Surveillance: Daniel Burge, M.D.

Safety Data, Epidemiology and Communications: Wayne Wallis, M.D.

Pharmacovigilance Program: Daniel Burge, M.D.

12:15 Centocor Presentation:

Introduction and Background: Jerry Boscia, M.D., Vice President, Clinical R&D

Communication Plan and Continuing Safety Assessment: Tom Schaible, Ph.D.,

Executive Director, Medical Affairs

Benefit/Risk: Jerry Boscia, M.D., Vice President, Clinical R&D, Centocor

12:45 Break

1:00 Questions and Discussion

2:00 Adjourn