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, IntroductionsConflict of Interest Statement
8:15 Welcome and Introduction to Today’s Issues
Overview of Asprin and NSAID Labeled Warnings
8:45 Open Public Hearing – Public Presentations
Rebecca Burkholder, National Consumers League
8:50
OTC NSAIDS and ASA GI Bleeding: Analysis of Spontaneous Reports
GI Risks of Over-the-Counter NSAID's
OTC NSAIDs and Nephrotoxicity
NSAIDs and Gastrointestinal and Renal Adverse Effects:
9:50 Questions to FDA
10:15
10:30 Open Public Hearing – Industry Presentations
Bayer Presenters– 30 minutes
3 minutes - Introduction
10 minutes - Overview of Safety Assessment
8 minutes - Comparative Safety of OTC Analgesics
7 minutes - Risk-Benefit of CV Uses of Aspirin
2 minutes - Conclusions
11:15
Questions to Bayer11:30
Wyeth Presenters5 minutes - Safety/Labeling
5 minutes - Renal considerations for NSAID's
5 minutes - GI/Renal toxicity (adults Vs younger populations)
5 minutes - Potential toxicity relative to overdose
11:50
Questions to Wyeth Presenters12:00
McNeil Presenter5 - Aspirin and Cardio Indications
5 - Review of Epidemiological Data on Aspirin and Other NSAID's
12:10
International Ibuprofen AssociationNicholas Moore, Professor of Clinical Pharmacology, CHU de Bordeaux, France
12:15
Questions to McNeil and International Ibuprofen12:30
Lunch1:30
Committee Discussion5:00
Approximate time of adjournment