Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

 

Joint Meeting of the

CDER Psychopharmacologic Drugs Advisory Committee

and the

FDA Pediatric Advisory Committee

 

September 13-14, 2004

 

Holiday Inn

8120 Wisconsin Avenue, Bethesda, Maryland

 

Issue: Discussion of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD) and other psychiatric disorders. Preliminary risk data based on the classification of these adverse event reports by the pharmaceutical sponsors of these products were presented at the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee held on February 2, 2004. Since that meeting, experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and the FDA has conducted an analysis of these data. The committees will consider the results of FDAs analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients. The committees will also consider further research needs to address questions on this topic.

 

Monday, September 13, 2004

 

8:00 Call to Order and Opening Remarks Wayne Goodman, M.D.

Chair, Psychopharmacologic Drugs Advisory Committee (PDAC)

Introduction of Committee

 

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

Executive Secretary, CDER, FDA

 

 

8:15 Overview of Issues Dianne Murphy, M.D.

Director, Office of Pediatric Therapeutics,

Office of the Commissioner

 

Russell Katz, M.D.

Director, Division of Neuropharmacological Drug Products (DNDP), CDER, FDA

8:30 Regulatory History and Background Thomas Laughren, M.D.

Team Leader, DNDP, CDER, FDA

 

8:45 Recent Observational Studies of Diane Wysowski, Ph.D.

Antidepressants (ADs) and Suicidal Behavior Epidemiologist, Division of Drug Risk Evaluation,

Office of Drug Safety (ODS), CDER, FDA

 

9:00 Brief Report on TADS Trial John March, M.D., M.P.H.

Duke University

9:15 Questions from the Committee

 

9:30 Characteristics of Pediatric Antidepressant Trials Greg Dubitsky, M.D.

Medical Officer, DNDP, CDER, FDA

 

9:40 Classification of Suicidality Events Kelly Posner, Ph.D.

Columbia University

 

10:05 OCTAP Appraisal of Columbia Solomon Iyasu, M.D., M.P.H.

Classification Methodology Team Leader, Office of Counter-Terrorism and Pediatric Drug Development (OCTAP), CDER, FDA

 


Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

 

Joint Meeting of the

CDER Psychopharmacologic Drugs Advisory Committee

and the

FDA Pediatric Advisory Committee

 

September 13-14, 2004

 

Monday, September 13, 2004, Agenda Continued

 

10:15 Questions from the Committee

 

10:30 Break

 

10:45 Results of the Analysis of Suicidality in Tarek Hammad, M.D., Ph.D., M.Sc., M.S.

Pediatric Trials of Newer Antidepressants Senior Medical Reviewer, DNDP, CDER, FDA

 

11:30 Comparison Between Original ODS and Andrew Mosholder. M.D., M.P.H.

Current DNDP Analyses of Pediatric Epidemiologist, Division of Drug Risk Evaluation, ODS,

Suicidality Data Sets CDER, FDA

 

11:45 Questions from the Committee

 

12:00 Lunch

 

1:00 Sponsor Presentations

 

Citalopram and Escitalopram Jeffrey Jonas, M.D.

Pediatric Safety Data Vice President, CNS, Forest Laboratories, Inc.

 

Sertraline Use in Pediatric Population: Charlotte Kremer, M.D.

A Risk Benefit Discussion Therapeutic Head, Psychiatry, WWM,

Medical and Development Sciences, Pfizer, Inc.

 

Title to be Announced Joseph S. Camardo, M.D.

Senior Vice President, Global Medical Affairs,

Wyeth Pharmaceuticals

 

2:00 Open Public Hearing

3:30 Break

 

3:45 Open Public Hearing

 

6:00 Summary by Committee Chair

 

6:15 Adjourn

 

 

Tuesday, September 14, 2004

 

8:00 Call to Order and Opening Remarks Wayne Goodman, M.D.

Chair, PDAC

 

8:15 Opening Comments Thomas Laughren, M.D.

Team Leader, DNDP, CDER, FDA

 

8:30 Committee Discussion

 

Summary Comments Wayne Goodman, M.D.

Chair, PDAC

Adjourn