The FDA's Risk/Benefit Calculus in the Approvals of Qsymia and Belviq: Treating an Obesity Epidemic While Avoiding Another Fen-Phen

摘要

The Food and Drug Administration (FDA) has a duty to protect public health by "assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emitradiation."1 Additionally, the FDA is responsible for "advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health."2 The public expects the FDA to use this authority to address major health challenges and approve pharmaceutical drugs when necessary to fight disease.