Joint Meeting of the Nonprescription Drugs and the
Endocrinologic & Metabolic Drugs Advisory Committee 

January 23, 2006

 

(OTC) use of Orlistat (tetrahydrolipstatin) capsules to promote weight loss in adults.

 

Slides Presented at Meeting

 

Welcome and Introductory Comments

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Andrea Leonard Segal, M.D.

Acting Director
Division of Nonprescription Clinical Evaluation

 

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

Medical Team Leader
Division of Metabolism and Endocrinology Products

 

History of the OTC Monograph
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Arlene Solbeck, M.S.

Senior Regulatory Review Scientist
Division of Nonprescription Regulation Development

 

Sponsor Presentations:

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Orlistat for Over-the-Counter Use

John Dent, Ph.D.
Senior Vice-President, Research & Development
GlaxoSmithKline

 

The Public Health Need for FDA-Approved Weight Loss Tool

Caroline Apovian, M.D.

Associate Professor of Medicine and Pediatrics, Boston

University School of Medicine

Director, Center for Nutrition and Weight Management,

Boston Medical Center

Co-Principal, New England Centers for Obesity Res & Ed

Vice-Chair, Massachusetts Med Soc Committee on Nutrition

 

Safety and Efficacy-Orlistat 60-120 mg       

Vidhu Bansal, Pharm.D.
Director, Medical Affairs; GlaxoSmithKline

 

Consumer Understanding and Use in OTC Setting

Saul Shiffman, Ph.D.

Research Professor of Health Psychology and

Pharmaceutical Sciences
University
of Pittsburgh

 

Orlistat’s Consumer Education and Behavioral Support Program

Steve Burton
Vice-President of Weight Control
GlaxoSmithKline

Summary and Commitments

John Dent, Ph.D.

Senior Vice-President, Research & Development
GlaxoSmithKline

 

FDA Presentations:

 

Safety and Efficacy Review
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Julie Golden, M.D.

Medical Officer
Division of Metabolism and Endocrinology Products

Label Comprehension Review

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Susanna Weiss, Ph.D., J.D.

Social Science Analyst
Division of Nonprescription Clinical Evaluation

 

Actual Use Study Review

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Karen Feibus, M.D.

Medical Officer

Division of Nonprescription Clinical Evaluation

 

Open Public Hearing Speakers

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Sidney M. Wolfe, M.D.

Public Citizen Health Research Group

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Laurie Tansman, M.S., R.D., C.D.N.

Mt. Sinai NYU Health

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Questions for the Committee

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