Draft 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
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 Acetaminophen Labeled Warnings
William Gilbertson, Pharm.D.., Associate Director of Drug Monographs,
Over-the-Counter Drug Products

8:45 FDA Acetaminophen Presentations

Acetaminophen Variability in Absorption and Metabolism
John Senior M.D., Senior Scientific Advisor, Office of Drug Safety

Acute Liver Failure in the US: Results of the US ALF Study Group
Will 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

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 of Clinical Hepatology Research, U 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 Bishop, 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