Current Obesity Reports

, Volume 3, Issue 3, pp 361–367

Anti-Obesity Agents and the US Food and Drug Administration

Hot Topic

DOI: 10.1007/s13679-014-0115-x

Cite this article as:
Casey, M.F. & Mechanick, J.I. Curr Obes Rep (2014) 3: 361. doi:10.1007/s13679-014-0115-x
  • 326 Downloads

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

ObesityWeight-loss drugsWeight managementAnti-obesity policyFDA

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