FDA widens scope of DTC impact survey

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Eleven years after giving DTC advertising the once-over, the FDA has teed up another review. This time, however, instead of focusing only on the channel's potential impact on patient-physician interactions, this latest survey is looking to a wider perspective and is looking to get input from nurse practitioners and physician assistants.

The agency indicated in the January 2012 Federal Register that it was a regulatory imperative to change the scope, because research has shown “nurses are the single largest group of healthcare providers in the United States,” and that NPs are going to “play an increasingly vital role in primary care delivery.” The study is now news because the Office of Management and Budget published a notice saying it approved of what is going to be studied and how.

Walgreen's recent push to use its drugstore's walk-in clinics to diagnose and treat chronic conditions shows just how this trend has taken hold. These Take Care Clinics are staffed by the very health professionals the FDA is seeking to include in its survey. There has also been a push among NPs to widen the scope-of-practice laws, which vary by state and determine what comes under their purview and just how independent they can be of a practicing physician, as some states require NPs be attached to a medical practice.

Just as in a 2002 survey, the FDA is hoping to get a sense of how healthcare professionals perceive DTC campaigns. The agency also wants this survey to correct an oversight: the last one was not “weighted to reflect national statistics of age, sex and racial composition of the healthcare population,” and this survey is meant to provide that balance.

According to FDA's announcement, it's also simply time for a re-do, noting that researchers can now “better assess how DTC advertising has unfolded in the United States.” At last check-in, FDA said doctors were split on whether they thought the ads had a negative impact on their practices. The agency also wants to assess the impact social media, increased online marketing and “the evolution of office detailing practices,” may have on how professionals perceive DTC's impact.

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