Direct-to-Consumer Ads are targeted to individual patients and try to address issues that affect a given patient highlighting the benefits and risks of drugs. The assumption usually is that a patient will make his or her own decision regarding pursuing prescription of the product in the drug advertisement. However, in real life, patients likely discuss these ads with their families and friends, with the spouses playing a major role in the final decision. For example, a couple may view an ad together and discuss drug benefits, side effects, and risks before the affected spouse decides to pursue the prescription with his or her physician. The spouse may influence if a patient decides to use a drug despite the side effects or may take a more conservative approach. These social interactions are of great interest to FDA to understand how drug ads play out in a real-life setting as these have important public health implications. To understand social interactions post drug ads, FDA wants to conduct a study to examine differences between consumers viewing prescription drug ads with a spouse versus alone. When this study was announced there were several concerns raised by the industry as to how the data generated from such study will be used. Some of the concerns were the legal and practical hurdles to applying data about perception of a drug ad’s impact when viewed by patient alone or with his/her spouse, applicability of the conclusions of the study in real world setting where there is no reliable data on the influence of spouse in the final decision other than anecdotal data, the design of the study to remove bias, and validity of the scales used. From public health point of view, it’s a troubling fact that the spouses can influence the buying decision regardless of whether the drug has side effects or not. The role one’s health condition and the age plays in decisions regarding drug ads should also be studied. However, FDA brushed off all concerns from the industry and is forging ahead with this study. We will keep our fingers crossed for the conclusions of the study and its impact on the rules governing drug ads.
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