Agenda June 21, 2002

Joint Meeting of the Nonprescription Drugs Advisory Committee with the Gastrointestinal Drugs Advisory Committees

Food and Drug Administration

Center for Drug Evaluation and Research

Holiday Inn, Bethesda

Prilosec (20 mg for 14 days ) for OTC use

(NDA 21-229, omeprazole magnesium, Astra Zeneca LP/Procter and Gamble)


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

Victor Raczkowski, M.D., Deputy Director, ODE II & Acting Director, Division of Gastrointestinal and Coagulation Drug Products

8:30 Open Public Hearing

9:00 Procter and Gamble Presentations:


Keith C. Triebwasser, Ph.D., Senior Director, Regulatory Affairs, Procter and Gamble

Clinical Perspective

David Peura, M.D., Associate Chief of Gastroenterology, University of Virginia

Efficacy and Consumer Use

Douglas Ws. Bierer, Ph.D., Director OTC Drug Development, Procter and Gamble

Safety Update in the OTC Setting

Douglas Levine, M.D., Chief Medical Officer, Gastrointestinal Therapeutic Area, AstraZeneca LP


Nora Zorich, M.D., Ph.D., Vice President Pharmaceuticals, Procter & Gamble


Keith C. Triebwasser, Ph.D.,

10:00 Questions from the Committee to Procter and Gamble

10:30 Break

11:00 FDA Presentations:

Summary of 2000 NDAC/GIAC meeting on Prilosec and Overview of Efficacy

Mark Avigan, M.D., Medical Officer, Division of Gastrointestinal and Coagulation Drug Products

Label Comprehension Studies

Karen Lechter, J.D., Ph.D., Office of Drug Safety

Actual Use Study

Daiva Shetty, M.D., Medical Officer, Division of Over the Counter Drugs

11:45 Questions from the Committee to the FDA

12:30 Lunch Break

1:30 Charge to the Committee

Linda Katz, M.D., MPH, Deputy Director, Division of Over-the Counter Drugs

5:00 Adjourn