FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

AGENDA

March 5, 2003

Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD

Topic: Discussion of the Formation of a List of Pathogens of Public Health Importance/ Discussion of How Preclinical Data and Clinical Data from One Disease State May Support Approval of Antimicrobial Drugs in Another, Separate Disease State

9:00 a.m. Call to Order James E. Leggett, Jr., M.D.

Acting Chair, AIDAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AIDAC

Opening Comments Mark Goldberger, M.D., M.P.H.

Director

Office of Drug Evaluation IV

Food and Drug Administration

9:15 a.m. Linkages of Resistance Determinants in Bacteria James H. Jorgensen, Ph.D.

Professor of Pathology

University of Texas Health Science Center

9:45 a.m. Questions from Committee

10:00 a.m. Industry Perspective on List of Pathogens Francis P. Tally, M.D.

Executive Vice President and Chief Scientific Officer
Cubist Pharmaceuticals, Inc.

10:20 a.m. Questions from Committee

10:30 a.m. Break

10:45 a.m. List of Pathogens of Public Health Importance John H. Powers, M.D.

Lead Medical Officer for

Antimicrobial Drug Development

Office of Drug Evaluation IV

Food and Drug Administration

11:15 a.m. Questions from Committee

12:30 p.m. Lunch

1:30 p.m. Open Public Hearing

2:00 p.m. How Clinicians Use Data for Clinical John S. Bradley, M.D.

Decision Making Director, Division of Infectious Diseases

Children’s Hospital San Diego

2:15 p.m. Relating Clinical Data from One Disease State to Edward Cox, M.D., M.P.H.

Another Deputy Director

Office of Drug Evaluation IV

Food and Drug Administration

2:30 p.m. Questions from Committee

2:45 p.m. Committee Discussion

5:00p.m. Summary and Adjourn James E. Leggett, Jr., M.D.