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DTC in Perspective: FDA Studying Spousal Influence in DTC Ads

June 11, 2015 by Bob Ehrlich0
Bob Ehrlich
“I am unclear what FDA will do with the results.”
-Bob Ehrlich

The FDA is interested in researching how drug ads are perceived when viewed alone versus with a spouse. They feel that when viewed with a spouse, drug benefit and risk may be interpreted differently. I think the study could yield interesting information. Does viewing with another person cause different benefit/risk takeaways? The FDA has a comment period ending 6/25/15.

Of course, the question is how FDA would regulate differently based on what is found. If viewing together causes increased risk concern, what changes would FDA make? The same goes for benefits. One would assume that two people viewing might remember more of the risk discussion since that is generally more complex than benefits. On the other hand, how would that change what is mandated by FDA?

Since FDA cannot regulate who watches an ad and with whom they watch, then how actionable is the data collected? Assuming joint viewing changes the perception, so what? My guess is that viewing with a spouse changes perception differently by drug category. A man with ED watching with his wife is probably going to have different results than for an allergy drug.

I think drug companies themselves are very interested in spousal influence on drug awareness and doctor inquiries. Clearly drug companies know spouses impact these decisions and create ads that mirror real life spousal discussions. Many DTC ads use husband and wife discussion to advertise drugs.

I am unclear what FDA will do with the results. I put this study in the nice to know category but far less important than risk communication studies they are also doing. We can assume that ads are viewed differently when watched together versus alone. Unless FDA can mandate how an ad is watched, then this study seems to be unnecessary. I expect FDA has a rationale for what would be done with the results in terms of guidance changes or other regulatory considerations. It would be interesting to hear what they say would be done with the results. In the comment section of the proposal they mention this study will benefit public health understanding. That, however, is such a broad answer that it has no practical interpretation regarding regulation.

The drug companies are skeptical based on comments already received. Lilly and Abbvie question the practical impact of this study. So do I. Interesting study but not likely useful in regulating advertising. This seems to be more of a study that a university or health think tank might do since they do not need to have a practical outcome. FDA, however, should only do studies that might change how they regulate advertising..

Bob Ehrlich

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