Final Agenda
September 19, 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 Acetaminophen
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 Acetaminophen Labeled Warnings
William Gilbertson, Pharm.D., Associate Director of Drug Monographs,
Division of Over-the-Counter Drug Products
8:45 FDA Acetaminophen Presentations
Acetaminophen Overview
John Senior M.D., Senior Scientific Advisor, Office of Drug Safety
Acute Liver Failure in the USA: Results of the US ALF Study Group
William Lee, M.D., University of Texas Southwestern Medical Center at Dallas
Epidemiology and Public Health Impact
Parivash Nourjah, Ph.D., Epidemiologist, Office of Drug Safety
Literature Review and Poison Control Data
Rizwan Ahmad M.D., M.P.H., Epidemiologist, Office of Drug Safety
FDA Adverse Event Reports (AERs)
Claudia Karwoski, Pharm.D., Team Leader, Office of Drug Safety
9:45 Questions to FDA
10:10 Break
10: 30 Open Public Hearing – Industry Presentations
McNeil
5 minutes - Introduction
Debra Bowen, M.D., Vice President, Research & Development
15 minutes - Acetaminophen Metabolism and Pharmacokinetics
John Slattery, Ph.D., Professor of Pharmaceutics, University of Washington
15 minutes - Assessment of Acetaminophen Safety
Richard Charles Dart, M.D., Ph.D., Director, Rocky Mountain Poison & Drug Center, Colorado
15 minutes - Acetaminophen Use in Selected Populations
Raymond S. Koff, M.D., Director, Clinical Hepatology Research, University of Massachusetts
5 minutes - Analgesic Benefit
Daniel B. Carr, M.D., Department of Anesthesia, Tufts New England Medical Center
5 minutes - Summary & Q&A
Anthony R. Temple, M.D., Vice President, Medical & Regulatory Science
11:20 Wyeth: Acetaminophen Background Rebuttal
Stephen Cooper, M.D., Senior Vice-President for Global Clinical and Medical Affairs
11:25 Bayer: OTC Acetaminophen Safety
Allen H. Heller, M.D., Vice President and Head Global Research & Development, Bayer
11:35 Questions to the Presenters
12:00 Lunch
1:00 Open Public Hearing – Public Presentations
10 minutes Sarah Erush, Pharm.D. and Karen Shalaby, Pharm D, University of Pennsylvania
5 minutes Susan Winckler, American Pharmacuetical Association
5 minutes Ray Bullman, National Council on Patient Information & Education
5 minutes Ms. Kate, Pennsylvania
5 minutes Caroline Riely, M.D., American Liver Foundation
5 minutes Peter Lurie, M.D., M.P.H, Assistant Director, Public Citizen Health Research Group
5 minutes Louis Lasagna, M.D., Tufts University
1:45 Committee Discussion
5:00 Approximate Time of Adjournment