DTC ads may have to be continually supported by ongoing clinical trials
Feb/14/2008 06:00 Filed in: DTC
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The label: it is the document from which all promotional claims flow, but if ongoing clinical studies do not support promotional claims than DTC marketers had better be ready to pull their ads. There will be "no grace period" allowing DTC claims to remain unchallenged while medical and regulatory people analyze the data, for in the eye of Congress and possibly the FDA this means "unsubstantiated claims". So the DTC message and positioning statement may have to evolve over time as ongoing clinical trials show new side effects or challenge efficacy claims. This of course means that DTC marketers are going to have to first set up a system where they can talk the same language as their medical and regulatory counterparts and then there is the agency integration. Watching the agency people sort through what they can and can't say and how messages need to be changed is going to be like watching a drunken monkey trying to install Windows Vista on a PC.
With every challenge, however, comes the opportunity for change. DTC marketers can take advantage of this situation to form a faster more responsive team that can quickly react to market changes, new clinical data and FDA requirements. They know that bringing agencies in as strategic partners can benefit the brand and ensure integration of message development and refinement. The more people you have on the same page the easier it will be to implement these programs. The issue is ensuring that your medical, regulatory and marketing people all speak the same language but more importantly trust each other. Medical and regulatory have always looked at marketing as "the dark side" and have been cautious of sharing information with them. Then there is the issue of clinical data itself. Now when companies get the clinical data they have to react. They can't take 3-6 months evaluating the data as the FDA would see that as trying to keep existing promotional claims that have been proven to be unsubstantiated.
There are a lot of challenges here but each day brings and opportunity for DTC marketers to finally start making a difference in the organization and in patients lives. I love DTC.......
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