WASHINGTON, D.C. The George Washington University School of Public Health and Health Services (GW) today released a report representing consensus findings from a cross-section of stakeholders that could help transform the process used to evaluate interventions to treat obesity, a public health crisis that now affects one in three adults. The report, "Obesity Drug Outcome Measures," results from a stakeholder dialogue group convened by GW that, over a period of nine months, explored why development and approval of obesity drugs have proven so difficult.
"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. "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."
Participants in the stakeholder group all contributed to the consensus report findings and included consumer advocates, obesity experts, researchers and clinicians. Officials from the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) participated in the dialogue process, but were not asked to endorse the final report.
The consensus report outlines a series of new approaches that should be considered by the FDA when evaluating the benefits and risks of obesity drugs including:
|Contact: Melissa Warren|
Chandler Chicco Agency