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]{.underline}**

#####  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]{.underline}**

-   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)]{.underline}***

#### 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 68^th^ 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)]{.underline}***

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)]{.underline}***

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