FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

September 8, 2004

Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave, Bethesda Maryland

AGENDA

The FDA draft guidance document entitled:

“GUIDANCE for the Clinical Evaluation of Weight-Control Drugs”

(dated 9/24/1996)

8:00 a.m. Call to Order and Introductions Glenn Braunstein, M.D.

Acting Chair, Endocrinologic and Metabolic

Drugs Advisory Committee, EMDAC

Conflict of Interest Statement LCDR Dornette Spell-LeSane, M.H.A., NP-C

Executive Secretary, EMDAC

Welcome and Introductory Comments David Orloff, M.D.

Director

Division of Metabolic and Endocrine

Drug Products (DMEDP), FDA

______________________________________________________________________________________

8:15 FDA Presentation

The Regulatory History of Weight-Loss Drugs Eric Colman, M.D.

Medical Team Leader

DMEDP, FDA

8:45 The Epidemiology of Overweight and Obesity Katherine Flegal, Ph.D.

Senior Research Scientist

National Center for Health Statistics

9:15 Current Status of Weight-Loss Drugs Frank Greenway, M.D.

Medical Professor, Director

Pennington Biomedical

Research Center

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

September 8, 2004

AGENDA

cont.

9: 45 Patterns of Weight-Loss Drug Use Laura A. Governale, Pharm.D., MBA Drug Utilization Specialist, Team Leader

Division of Surveillance

Research and Communication Support

Office of Drug Safety (ODS), FDA

10:15 Break

10:30 FDA Presentation, cont.

Role of Drugs in the Treatment Richard L. Atkinson, M.D.

of Obesity: Current and Future Director, Obetech

Obesity Research Center

11:00 Open Public Hearing

The 1996 FDA Draft Guidance Document David Orloff, M.D.

Director, DMEDP

Charge to the Committee David Orloff, M.D.

Director, DMEDP

12:30 Lunch

1:15 Committee Discussion/Questions

4:30 Adjourn