Consensus: FDA Should Focus on Obesity, not Weight Loss

August 14, 2012 — Today, the George Washington University School of Public Health held a live panel discussion to talk about the just-released consensus report developed by a range of obesity experts in the last nine months to help guide the FDA when evaluating the benefits and risks of potential new obesity drugs. Until this summer, when two new obesity drugs were approved by the FDA, experts in the field have been frustrated with the FDA review process and lack of new treatments.The group who developed the report include the following experts in public health, patient advocacy, medical research, obesity medicine and academia:

Louis Aronne, M.D., Weill-Cornell Medical College
Craig Audet, Arena Pharmaceuticals, Inc.
Sarah Clauss, M.D., FACC, Children’s National Medical Center
Christine Ferguson, J.D., The George Washington University
Ken Fujioka, M.D., Scripps Health
Neil Gesundheit, M.D., Stanford University
Scott Kahan, M.D., M.P.H., The George Washington University, Johns Hopkins
Preston Klassen, M.D., M.H.S., Orexigen Therapeutics, Inc.
Ted Kyle, RPh, ConscienHealth, The Obesity Society
Jeff Levi, Ph.D., Trust for America’s Health
Nazrat Mizra, M.D., ScD, Children’s National Medical Center
Joe Nadglowski, Obesity Action Coalition
Patrick O’Neil, Ph.D., The Obesity Society
Domenica Rubino, M.D., Washington Center for Weight Management and Research
Donna Ryan, M.D., Pennington Biomedical Research Center
Kate Ryan, M.P.A., National Women’s Health Network
Susan Wood, Ph.D., The George Washington University
Thomas Strack, M.D., Takeda Pharmaceuticals USA, Ince.
Diana Zuckerman, Ph.D., National Research Center for Women and Families

Federal Government Observers
Eric Colman, M.D., FDA, Center for Drug Evaluation and Research
Bill Dietz, M.D., Ph.D., CDC, Division of Nutrition, Physical Activity, and Obesity
John Jenkins, M.D., FDA, Center for Drug Evaluation and Research
Theresa Mullin, Ph.D., FDA, Center for Drug Evaluation and Research
Janet Woodcock, M.D., FDA, Center for Drug Evaluation and Research
Susan Yanovski, M.D., NIH, NIDDK, Division of Digestive Diseases and Nutrition

The group hopes the report will encourage the FDA to consider measures that extent beyond numerical weight loss such to functioning and feeling when considering new drug approvals. “At a time when so many Americans suffer with obesity and are faced with limited treatment options, there has been a rising call to review the emerging science on obesity to update the framework used when evaluating obesity drugs,” said Christine Ferguson, J.D., Professor in the Department of Health Policy at  GWU. “The FDA, under a reauthorized Prescription Drug User Fee Act, is likely to take a wider, more comprehensive look at how drugs developed to treat obesity affect how individuals with obesity feel and function. This report may help update the risk-benefit framework.”

You can read the GWU press release here and the full report here.