Current Obesity Reports

, Volume 3, Issue 3, pp 361–367 | Cite as

Anti-Obesity Agents and the US Food and Drug Administration

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Abstract

Despite the growing market for obesity care, the US Food and Drug Administration (FDA) has approved only two new pharmaceutical agents—lorcaserin and combination phentermine/topiramate—for weight reduction since 2000, while removing three agents from the market in the same time period. This article explores the FDA’s history and role in the approval of anti-obesity medications within the context of a public health model of obesity. Through the review of obesity literature and FDA approval documents, we identified two major barriers preventing fair evaluation of anti-obesity agents including: (1) methodological pitfalls in clinical trials and (2) misaligned values in the assessment of anti-obesity agents. Specific recommendations include the use of adaptive (Bayesian) design protocols, value-based analyses of risks and benefits, and regulatory guidance based on a comprehensive, multi-platform obesity disease model. Positively addressing barriers in the FDA approval process of anti-obesity agents may have many beneficial effects within an obesity disease model.

Keywords

Obesity Weight-loss drugs Weight management Anti-obesity policy FDA 

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.Division of Endocrinology, Diabetes, and Bone DiseaseIcahn School of Medicine at Mount SinaiNew YorkUSA
  2. 2.New YorkUSA

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