Anti-Obesity Agents and the US Food and Drug Administration

• Published in: Current obesity reports 2014-09, Vol.3 (3), p.361-367
• Main Authors: Casey, Martin F., Mechanick, Jeffrey I.
• Format: Article
• Language: English
• Subjects: Behavioral Therapy; Cardiology; Diabetes; Endocrinology; Hot Topic; Medicine; Medicine & Public Health; Metabolic Diseases
• ISSN: 2162-4968; 2162-4968
• DOI: 10.1007/s13679-014-0115-x

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.