New approaches for evaluating benefits and risks of obesity drugs

"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:

• Obesity affects everyone differently. Evaluating the benefits and risks of interventions should reflect the various considerations within the different categories of obesity based on feeling, functioning and health impairments.

• Obesity drugs may provide an additional option for helping individuals who do not respond, or inadequately respond, to other interventions.

• Potential pharmaceutical interventions should be reviewed as obesity treatments rather than weight loss agents and should be limited to only those for whom they are medically appropriate.

• The benefit-risk evaluation of treatment with obesity drugs should extend beyond numerical weight loss to improvement in feeling and functioning.