Draft Agenda: September 20, 2002

Nonprescription Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Hilton, Silver Spring Maryland

8727 Colesville Road

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

8:45 Open Public Hearing – Public Presentations

Rebecca Burkholder, National Consumers League

8:50 FDA Presentations

OTC NSAIDS and ASA GI Bleeding: Analysis of Spontaneous Reports
 Joyce Weaver, Pharm.D., Office of Drug Safety

GI Risks of Over-the-Counter NSAID's
 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 Adverse Effects:
 Marie Griffin, M.D., Vanderbilt University, Nashville, Tennessee

9:50 Questions to FDA

10:15 Break

10:30 Open Public Hearing – Industry Presentations

Bayer 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

8 minutes - Comparative Safety of OTC Analgesics
 James F. Fries, M.D., Professor of Rheumatology, Stanford School of Medicine, Palo Alto, CA

7 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 Presenter

5 - Aspirin and Cardio Indications
Eric Jeffrey Topol, M.D., Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

5 - Review of Epidemiological Data on Aspirin and Other NSAID's
 Kenneth J. Rothman, DrPH , 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

12:15 Questions to McNeil and International Ibuprofen

12:30 Lunch

1:30 Committee Discussion

5:00 Approximate time of adjournment