Final Agenda
(revised to reflect the changes)
September 20, 2002
Nonprescription Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Hilton Hotel, Silver Spring Maryland
8727 Colesville Road
Safety Issues related to ASA and NSAIDs
8:00 Call to Order, Introductions
Conflict of Interest Statement
Sandra Titus, Ph.D., Executive Secretary, NDAC
8:15 Welcome and Introduction to Today’s Issues
Charles Ganley, M.D., Director, Division of Over-the-Counter Drug Products
Overview of Asprin and NSAID Labeled Warnings
William Gilbertson, Pharm.D., Associate Director of Drug Monographs, Division of Over-the-Counter Drug Products
8:40 Open Public Hearing – Public Presentations
Rebecca Burkholder, National Consumers League
8:50 FDA Presentations
OTC NSAID and ASA GI Bleeding: Analysis of Spontaneous Reports
Joyce Weaver, Pharm.D., Office of Drug Safety
Risk of NSAIDs: Focus on GI Risks of Over-the-Counter NSAIDs
Byron Cryer, M.D., University of Texas Southwestern Medical School
OTC NSAIDs and Nephrotoxicity
Juan Carlos Pelayo, M.D., Division of Cardio-Renal Drug Products
NSAIDs and Gastrointestinal and Renal Complications: Lessons from Tennessee Medicaid Population Studies
Marie Griffin, M.D., Vanderbilt University, Nashville, Tennessee
9:50 Questions to FDA
10:15 Break
10:30 Open Public Hearing – Industry Presentations
ayer Presenters– 30 minutes
3 minutes - Introduction
Allen H. Heller, M.D., Bayer Consumer Care Division
10 minutes - Overview of Safety Assessment
Gerald A. Faich, M.D., M.P.H, Consultant, Philadelphia, PA
15 minutes - Risk-Benefit of CV Uses of Aspirin
Charles H. Hennekens, M.D., Dr.P.H, Visiting Professor of Medicine, Epidemiology & Public Health, University of Miami
2 minutes - Conclusions
Allen H. Heller, M.D., Bayer Corporation, Consumer Care Division
11:15 Questions to Bayer
11:30 Wyeth Presenters
5 minutes - Safety/Labeling
Roger G. Berlin, M.D., FACP, FACG , President Global Scientific Affairs
5 minutes - Renal considerations for NSAID's
Domenic A. Sica, M.D., School of Medicine, Medical College of Virginia Commonwealth University,
Medicine and Pharmacology Department of Internal Medicine/Nephrology/Pharmacology & Toxicology
5 minutes - GI/Renal toxicity (adults Vs younger populations)
Philip Walson, M.D., Professor, Pediatric Pharmacology & Pharmacy, University of Cincinnati
5 minutes - Potential toxicity relative to overdose
Richard Weisman, Pharm. D., Director, Florida Poison Control Center – Miami
11:50 Questions to Wyeth Presenters
12:00 McNeil Presenters
10 - Review of Epidemiological Data on Aspirin and Other NSAID's
Kenneth J. Rothman, Dr.PH. , Professor, Epidemiology & Biostatistics, Boston University School of Public Health
12:10 International Ibuprofen Association
Michael Langman, M.D., University of Birmingham
Nicholas Moore, Professor of Clinical Pharmacology, CHU de Bordeaux, France
12:20 Questions to McNeil and International Ibuprofen
12:30 Lunch
1:30 Committee Discussion
6:00 Meeting adjourned