FDA study of couples' DTC ad viewing moves forward, but should it?

The FDA is intent on studying the potential influence a spouse may have when patients view DTC ads on television. But the pharma marketing industry has its own questions--mostly, what is the FDA thinking?

Comments from two pharma companies were filed in the FDA's second submission to the Office of Management and Budget, and both AbbVie ($ABBV) and Eli Lilly ($LLY) seem to agree that taxpayer money could be better spent elsewhere.

AbbVie's one comment: "It is difficult to ascertain how the Agency will utilize the results of this study should it demonstrate that the perception of ads differs when viewed alone or with someone else. Regulating companion versus solitary viewing practices would present insurmountable legal and practical hurdles.

"Rather than conduct this study, we suggest that FDA resources and taxpayer dollars would be better directed to research that enhances the quality of how we communicate benefit and risk information to consumers regardless of the setting in which the ad is viewed."

Undaunted, the FDA replied to that assertion, insisting that partner influence is important and the study may even lead to agency action. Depending on the findings, "organizations involved in developing DTC drug communications may be encouraged to remain aware of the social context in which DTC ads are often viewed and the influence of this context on consumer perceptions, judgments, and decisions."

The result? Better communications to consumers "that remain accurate and balanced regardless of setting," the agency stated. In other words, the same ad for viewing separate and together--but maybe a different one from those in the past.

Lilly's 9 comments were more specific, but similar in tone, pointing to several survey questions it found "ambiguious and unclear," as well as a more general statement: "We are challenged to understand how this research yields any useful, actionable information when it is impractical to influence who is watching TV advertisements at any given time."

The FDA still didn't back down, with its response re-iterating its view of the importance of the information. From the FDA: "It is important to generate insight about not only the message portrayed in DTC TV ads but also the conditions under which these messages are received and processed."

ANA's Dan Jaffe

Dan Jaffe, the executive VP of government relations for the ad industry association, the Association of National Advertisers, agrees with both pharma commenters. "I'm not looking at this study and saying it's a terrible thing, but if they're trying to use their limited money resources in the most effective way, I don't see how the outcome of this could possibly result in more effective messages to consumers," Jaffe told FiercePharmaMarketing. "The FDA's responsibility is to make sure advertising is presented in a clear, truthful and non-deceptive way. Are they trying to suggest that if a partner is in the room, suddenly the ad is less truthful or clear? … And even if it is, what do you do about it?"

The FDA's Office of Prescription Drug Promotion Research, which currently has 14 advertising studies proposed, plans to set up this study with asthma patients and their partners. The in-person study will require participants to view randomly assigned versions of TV ads--one for a low benefit, low risk drug and the second for a high benefit, high risk drug. Responses about each ad when watching alone versus watching together with their partner will be recorded.

Jaffe also pointed out that "as an advertiser I'd be very skeptical" concerning the information gathering process conducted in non-real world situations where people are put into a room and asked to talk about advertising.

- see the FDA filing
- check out the FDA's list of proposed studies

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