What’s Up with the FDA – Part 5

September 6th, 2011 by MorganDowney Leave a reply »

My colleagues, Christopher Still of the Geisinger Obesity Institute, and Arya Sharma, of the University of Alberta and I , have just published an article, Is there a path for approval of an anti-obesity drug at the FDA. The article analyzes in some depth the reviews by the FDA of the 3 new drug applications and the review of the approved drug, sibutramine. All the new applications were turned down and sibutramine was withdrawn after a split vote by the advisory committee. The article describes the conceptual quagmire the FDA is in regarding drugs to treat obesity. Rather than depend on the results of studies, conclusions reached by FDA are often based on assumptions and fears.

We conclude that obesity is simply too important to go without drug therapy and recommends that FDA, NIH, industry and researchers must work together to design a methodology to gain approval for obesity pharmacotherapy in the future.

Is there a path for appro… [Curr Opin Endocrinol Diabetes Obes. 2011] – PubMed – NCBI