Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Tim K Mackey

doi:10.15171/ijhpm.2016.11

Abstract

The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the "disruptive" qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored.

Highlights

Arecent study by Kim conducted a content analysis of notices of violations (NOVs) and warning letters issued by the U.S Food and Drug Administration (FDA) over a 10-year period (2005-2014).[1]
One striking example of the potential limitations of NOVs/ warning letters as a secondary data source in order to understand eDTCA trends is Kim’s finding that only two FDA actions targeted social media.[1]. This result seems peculiar especially given the high-degree of popularity of social media in health communications, prior studies that have reported near universal use of these platforms by large pharmaceutical firms, and another study that found a majority of eDTCA drug product claims emphasized benefits over risks.[7,15,16]
Other minor findings in Kim’s study making up a smaller percentage of NOV/warning letter content characteristics should raise alarms. This includes pharmaceutical companies directly contacting consumers via email and their attempt to use these same consumers to propagate their direct-to-consumer advertising (DTCA) via social media.[1]. This blunt form of “marketer controlled” DTCA by attempting to use patients as “third-party endorsers” raises privacy concerns regarding the use of protected health information (PHI) and could possibly violate the US Health Insurance Portability and Accountability Act (HIPPA) These violations may be a byproduct of a DTCA channel that has been largely neglected in pharmaceutical marketing research: the use of branded and unbranded patient engagement portals operated under the control of a pharmaceutical firm that create online environments where manufacturers can control interactions between current and prospective consumers.[26]

Summary

Introduction

Arecent study by Kim conducted a content analysis of notices of violations (NOVs) and warning letters issued by the U.S Food and Drug Administration (FDA) over a 10-year period (2005-2014).[1].

Results

Conclusion