FDA to Study Corrective DTC
“I applaud this study..how to manage the corrective remedy.”
Here is a topic that is clearly under-studied. If a drug company violates FDA promotional DTC regulations, is corrective advertising actually an appropriate remedy in correcting the original consumer misimpressions? While corrective advertising has been assumed to help undo the original misstatements, is there any empirical evidence it actually succeeds?
FDA is planning to do such a study and I agree this makes sense. After all, the purpose of corrective ads is to admit the faulty ads were wrong and get consumers to understand what was wrong and what is now the truth. If FDA better understands how corrective ads are interpreted, then they can better understand how to supervise them. Consumers deserve the truth, and to get that truth, FDA needs to understand how best to undo he harm of the original ad.
Corrective ads are seen as the ultimate punishment because a drug company is using precious media spending to tell consumers they were wrong in what they said. Drug companies have an interest in making corrective ads seem benign and a mere update of information rather than an admission of serious errors. FDA wants consumers to have the truth about efficacy and safety. How these ads are executed will determine what consumers take away.
FDA will learn a lot from this study but it is only a beginning. The research design is for a made up drug in a medium incidence drug category. FDA will test time exposure for corrective ads after original ad and the ad element similarity for corrective and original ad. Corrective ads may be best if they look the same as the original ad but that may not be the case. Perhaps corrective ads should be dissimilar so consumers instantly know it is a corrective ad. There have been no studies to show which approach is best. This study will help determine that.
There is also no evidence of what media weight is needed to correct misimpressions from a violative ad. Is it one for one or does it take a multiple of corrective weight. This study does not seem to measure that and could be important for future study. Most corrective programs require the same weight as the original. It may be inadequate. Obviously the greater the potential penalty, the more cautions advertisers will be in the original ad.
I applaud this study because it is so important to know how to manage the corrective remedy. For drug companies avoiding corrective penalties is critical and pre-clearance is the best way to do it. No CEO wants their drug to be cited for a corrective program. It is rarely used by FDA and is a powerful deterrent. If used, however, it should benefit the consumer and this study will identify how best to do that.
Bob Ehrlich, Chairman
DTC Perspectives, Inc