Anti-Infective Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Holiday Inn, 8777 Georgia Ave., Silver Spring, MD

"safety and efficacy of 1-day and 3-day dosing regimens of

azithromycin suspension (New Drug Application 50-710, Pfizer Inc.)

for the treatment of otitis media."

Agenda - November 7, 2001

8:00 Call to Order, Introductions - L. Barth Reller, M.D., Chair

Meeting Statement - Thomas H. Perez, M.P.H., Executive Secretary

8:10 Welcome and Introduction - Janice Soreth, M.D., Acting Director,

Division of Anti-Infective Drug Products

8:30 Design of Clinical Trials of Antibiotic Therapy for AOM – Colin Marchant, M.D.,

9:00 Pfizer Inc. Presentation:

Azithromycin in the Treatment of Acute Otitis Media - Michael W. Dunne, M.D., Vice President, Clinical Development, Infectious Diseases, Pfizer Global Research and Development

The Bacterial Pathogenesis of Acute Otitis Media - Edward J. O'Rourke, M.D., Professor of Pediatrics, Harvard Medical School

10:30 Break

10:45 FDA Presentation:

Azithromycin for AOM – Nasim Moledina, M.D., Division of Anti-Infective Drug Products

11:15 Open Public Hearing

12:15 Lunch

1:15 Discussion of Questions and Vote

3:00 Continuation of AOM Clinical Trials Discussion

Introduction – John Alexander, M.D., Division of Anti-Infective Drug Products


Consultants and Guests

Celia Maxwell, M.D., Associate Professor of Medicine, Howard University

Jane L. Burns, M.D., Associate Professor of Pediatrics, University of Washington

Jan Patterson, M.D., Professor of Medicine and Pathology, University of Texas Health Science Center,

Colin Marchant, M.D., Boston Medical Center

Mary Glode, M.D., Professor of Pediatrics, University of Colorado Health Sciences Center

Richard Gorman, M.D., Pediatrics Subcommittee of the AntiInfective Drugs Advisory Committee



Open Public Hearing Participants

Michael R. Jacobs, M.D., Professor of Pathology Case Western Reserve University

Ron Dagan, M.D., Director, Pediatric Infectious Disease Unit, Soroka Medical Center

Sidney Wolfe, M.D., Director, Public Citizen’s Health Research Group