Agenda May 11, 2001

Joint Meeting - Nonprescription Drugs Advisory Committee &

Pulmonary - Allergy Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Gaithersburg, MD

Petition 98P-0610/CP1 - submitted by Blue Cross of California requesting fexofenadine hydrochloride, loratadine and cetrizine hydrocholoride to OTC status


8:00 Call to Order, Introductions

Eric Brass, M.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 Drugs

8 :30 Blue Cross Petition

Robert Seidman, PharmD., M.P.H., Vice President, Wellpoint Health Networks, Pharmacy Department

Michael Nichol, Ph.D., University of Southern California, School of Pharmacy

Jack Kern, Pharm.D., University of Southern California, School of Pharmacy

9:00 Questions from the Committee to Blue Cross

9:15 Response to Petition by Aventis

Francois Nader, M. D., Senior Vice President of Medical and Regulatory Affairs, Aventis

9:30 Response to Petition by Schering-Plough

Robert Spiegel, M.D., Sr.V.P. Medical Affairs, Chief Medical Officer; Schering Plough Research Institute

9:45 Questions from the Committee to Aventis , Schering-Plough and Pfizer

10:00 Break

10:15 Open Public Hearing

11:00 FDA Presentation

OTC Considerations

Cazemiro Martin, Division of Over-the-Counter Drugs

Clinical Safety Overview

Robert Meyer, M.D., Director, Division of Pulmonary and Allergy Drugs

11:45 Questions from the Committee to the FDA

12:00 Lunch Break

1:00 Open Public Hearing

2:00 Committee Discussion

5:00 Adjourn