FDA Approval and Surveillance Process for Anti-obesity Drugs and Devices

Abstract

As we are all aware, obesity has become one of the country’s major public health issues of the last few decades, with the number of the obese and super-obese rising steadily over that period of time. There is no magic cure to treat this patient population, and the medical community has come to realize that the old “standard” of diet and exercise has not reversed this trend. Drug and medical device companies have developed drugs and devices to treat obese patients. The mission of both CDER and CDRH is to protect and promote the public health by helping to assure that drugs and devices are safe and effective for their intended use and patient populations. To assure that these products meet the appropriate regulatory standards for marketing, FDA works with drug and device manufacturers throughout product development, regulatory analysis, and the post-marketing phases of their product. In this chapter we will present some of the drug and device data for weight loss, as well as the FDA surveillance of post-market data to continue the assessment of safety and effectiveness of these drugs and devices.