The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure

Abstract

Over the past forty-five years, America has fallen victim to an obesity epidemic, affecting more than thirty percent of American adults. If the incidence of obesity continues at current rates, an estimated forty-percent of Americans will be obese by 2018. Despite its widespread prevalence, treatment is limited to lifestyle modification, surgery, and pharmacotherapy. With lifestyle modification proven to be largely ineffective, surgical options reserved only for the severely obese, and only one long-term drug on the market, there is a vacuum in obesity treatment options. Moreover, the Food and Drug Administration recently rejected three promising drugs. In this paper, I review the obesity problem facing America and describe the history of anti-obesity pharmaceuticals. After examining the three recently rejected drug applications, I bring to light FDA’s new priorities and offer an alternative framework for thinking about pharmacology to guide anti-obesity drug development and review.