Obesity Food and Drug Administration’s Obesity Drug Guidance Document A Short History

An estimated 70% of adult men and 60% of adult women in the United States are overweight or obese.1 Excess body fat increases the likelihood of developing hypertension, dyslipidemia, and type 2 diabetes mellitus and is an independent risk factor for cardiovascular disease.2–4 Obesity is linked to an increased risk for certain cancers, osteoarthritis, and sleep apnea.5–8 Obese people are stigmatized.9 Medical costs attributable to obesity are enormous.10 The healthcare community and patients would thus welcome the development and approval of new obesity drugs with favorable benefit-risk profiles. To facilitate drug development, the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research issues guidance documents for the pharmaceutical industry. These documents provide the agency’s current thinking on therapeutic indications, target populations, clinical trial designs, and data analyses. This article examines the origins and evolution of the FDA’s guidance document for the development of drugs to treat obesity.