Obesity Drug Outcome Measures: Results of a Multi-Stakeholder Critical Dialogue

Abstract

There has been great interest in what role drugs should play in the treatment of obesity. Given the complex and multifactorial nature of obesity, drugs represent a valuable adjunct to traditional obesity treatments. However, obesity drugs present specific regulatory challenges, due to the sheer number of individuals affected, the heterogeneity of how obesity affects individuals differently, and the potential for drugs to be misused, especially by those seeking or profiting from cosmetic weight loss. There is a need to refine the characterization of the individuals most at risk from obesity to better assess the balance of benefits versus risks and determine appropriate candidates for drug therapy. As obesity affects feeling, functioning, and survival, outcome measures that reflect improvement in these domains should be explicitly incorporated into regulatory guidance. Regulators could benefit from mechanisms that limit or closely monitor off-label use and thereby allow approval of drugs for narrowly indicated populations. © 2013 Springer Science+Business Media New York.