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
Louis Cantilena, M.D., Ph.D., NDAC Chair

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 Presenters30 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