Although only possible in two nations, New Zealand and the United States, directto-consumer advertising (DTC) of prescription medicine has generated international controversy. This paper examines how DTC emerged, compares the different regulatory structures used to govern it and analyses the debate over the ethics and effects of DTC. While the value of providing information to consumers is indisputable, serious questions remain over the quality of information provided via DTC, whether any benefits it might bring offset its wider social and economic costs, and how best to achieve a balance between commercial and public health objectives. Copyright (C) 2007 John Wiley & Sons, Ltd.