Categories: FDA, Pharmaceuticals

On November 13, 2014, the Food and Drug Administration ("FDA") announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements.  FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made.  For example, FDA notes that when spouses view an ad together a spouse "may influence their partner by expressing concern about risk and sides effects that might occur, or pressuring their partner to consider the drug despite the risks and side effects."  The FDA proposes to examine the influences spouses may have on the consumer's memory and understanding of risks and benefits information, intention to seek more information about the product, and variables pertaining to the consumer-spouse relationship (such as closeness and communication style).

FDA's proposed study recognizes the strong influence that spouses have on shaping treatment decisions. Studies have shown that married people are generally healthier than unmarried people, and that "a spouse may play an important role in monitoring and encouraging healthy behaviors… as well as discouraging unhealthy ones."  How a spouse shapes the consumer's perceived risks in relation to the benefit of the advertised drug is important not only to regulators but to the drug manufacturers as well.

FDA Guidance for Industry on Presenting Risk Information in Prescription Drug and Medical Device Promotion describes how advertisements should present information about effectiveness and information about risk in a balanced manner. Specifically, "[i]f the benefits information is easily understood and maintained through repetition or other reinforcing techniques, and risk information is not similarly reinforced, the net impression may not be appropriately balanced." (emphasis added)   FDA is concerned with whether, as a whole, the communication provides an accurate and non-misleading impression of the product.

It remains to be seen whether FDA intends to use the results of the study to expand its review of promotional materials to include consideration of the potential influence of the promotional materials on a spouse, who will ultimately influence the consumer's treatment decisions. It's common to see drug advertisements showing a happy, healthy couple walking down a beach or playing in a back yard with grandchildren. If this touching scene causes a spouse to press his or her partner to seek more information about product will that make an otherwise balanced communication misleading?  Companies should be mindful of this proposed study and the possible impacts upon their product marketing.

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