title: Anti-Obesity Agents and the US Food and Drug Administration.
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.
authors.affiliation: Division of Endocrinology, Diabetes, and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.
authors.forename: Martin F
authors.initials: MF
authors.lastname: Casey
authors.affiliation: Division of Endocrinology, Diabetes, and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA. jeffreymechanick@gmail.com.|, 1192 Park Avenue, New York, NY, 10128, USA. jeffreymechanick@gmail.com.
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Mechanick
keywords: Anti-obesity policy; FDA; Obesity; Weight management; Weight-loss drugs