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

DRAFT AGENDA

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

______________________________________________________________________________________

The FDA draft guidance document entitled:

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

(dated 9/24/1996)

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 TBA

9:15 Current Status of Weight-Loss Drugs TBA

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

September 8, 2004

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)

10:15 Break

10:30 FDA Presentation Continued

The 1996 FDA Draft Guidance Document David Orloff, M.D.

Director, DMEDP

11:00 Open Public Hearing

12:00 Lunch

1:00 Questions from the Committee

2:00 Charge to the Committee David Orloff, M.D.

Director, DMEDP

2:15 Committee Discussion

3:15 Break

3:30 Committee Discussion

5:00 Adjourn