Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

 

Psychopharmacologic Drugs Advisory Committee

 

June 16, 2003

 

Marriott Washingtonian Center - Rio

9751 Washingtonian Boulevard, Gaithersburg, Maryland

 

 

 AGENDA

 

8:00     Call to Order and Opening Remarks                          Matthew Rudorfer, M.D

                                                                                                Acting Chair

            Introduction of Committee

 

            Conflict of Interest Statement                                      Anuja M. Patel, M.P.H.

                                                                                                Executive Secretary, FDA

 

Discussions on the white blood cell (WBC) monitoring schedule for patients being treated long-term with clozapine.  Currently, the WBC monitoring schedule is weekly for the first six months of continuous therapy and biweekly thereafter.  The committee will consider the question of whether the frequency of WBC monitoring can be diminished further following some period of biweekly monitoring.

 

8:15     Opening Remarks                                                        Russell Katz, M.D.

                                                                                                Director, Division of

Neuropharmacologic Drug Products, FDA

           

Overview of Issues                                                     Judith A. Racoosin, MD, MPH Safety Team Leader, Division of Neuropharmacologic Drug Products, FDA           

8:45     Sponsor Presentations

            Novartis Pharmaceuticals Corporation

·       Introduction                                                           James Rawls, Pharm.D.

Associate Director,

Drug Regulatory Affairs

Novartis Pharmaceuticals Corp.

 

·       Overview of Agranulocytosis                               Stanton Gerson, M.D. 

                        Chief, Division of Hematology

and Oncology

Department of Medicine,

Case Western Reserve University

Psychopharmacologic Drugs Advisory Committee

June 16, 2003

AGENDA (cont.)

 

Sponsor Presentations (cont.)

 

·       Clozaril Registry Data                                          Vinod Kumar, M.D.

Executive Director,

Clinical Development and Medical Affairs

Novartis Pharmaceuticals Corp.

 

·       Quantitative Analysis of US Data                          Lawrence Hauptman, Ph.D.

Director, Drug Regulatory Affairs

Novartis Pharmaceuticals Corp.

 

·       Summary and Conclusion                                      John M. Kane, M.D.

Professor of Psychiatry, Neurology and Neuroscience Albert Einstein College of Medicine

 

10:15   Questions from Committee to Sponsor

 

10:30   Break

           

10:45   FDA Presentation

·       Discussion of Selected Safety Data                       Tarek A. Hammad, M.D., Ph.D

            Safety Medical Reviewer, Division of Neuropharmacologic Drug Products, FDA   

 

11:15   Questions from Committee to FDA

 

12:00   Lunch

 

1:00     Open Public Hearing

 

2:00     Continuation of Committee Discussion and Response to FDA Questions

 

            Break

 

5:00     Adjourn

 

Psychopharmacologic Drugs Advisory Committee

June 16, 2003

 

 

Special Government Employee (SGE) Consultants (voting)

 

Jean Bronstein  (Consumer Representative)

814 Beaverton Court

Sunnyvale, California 94087

 

Paul Keck, M.D.

Professor of Psychiatry

University of Cincinnati, College of Medicine

231 Albert Sabin Way – Room 7208

Cincinnati, Ohio  45267

 

Ellen Leibenluft, M.D.

Pediatrics and Developmental Neuropsychiatry Branch

Mood and Anxiety Program

National Institute of Mental Health

Building 10, Room 4N-208

10 Center Drug MSC 1255

Bethesda, Maryland  20892-1255

 

Andrew C. Leon, Ph.D.

Professor of Biostatistics in Psychiatry

Weill Medical College of Cornell University

Department of Psychiatry – Box 140

525 East 68th Street

New York, New York 10021

 

Neal Ryan, M.D.

Professor of Psychiatry

Joaquim Puig-Antich Professor of Psychiatry

University of Pittsburgh, School of Medicine

Western Psychiatric Institute and Clinic

3811 O’Hara Street

Pittsburgh, Pennsylvania  15213

 

Philip S. Wang, M.D., Dr.P.H.

Instructor in Epidemiology, Harvard School of Public Health

Instructor in Health Care Policy, Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics,

Brigham and Women’s Hospital

221 Longwood Avenue, Suite 341

Boston, Massachusetts  02115

Psychopharmacologic Drugs Advisory Committee

June 16, 2003

 

 

Special Government Employee (SGE) Consultants (voting)

 

Sheila Weiss, Ph.D.

Assistant Professor

Department of Pharmacy Science and Practice

School of Pharmacy

University of Maryland at Baltimore

100 Penn Street, Suite 240

Baltimore, Maryland  21201

 

 

Acting Industry Representative (non-voting)

 

Dilip J. Mehta, M.D., Ph.D.

870 United Nations Plaza

New York, New York  10017

 

Psychopharmacologic Drugs Advisory Committee

June 16, 2003

 

 

Open Public Hearing Speakers