Kerman University of Medical Sciences International Journal of Health Policy and Management 2322-5939 5 4 2016 04 01 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” 271 274 3154 10.15171/ijhpm.2016.11 EN Tim K. Mackey Department of Anesthesiology, San Diego School of Medicine, University of California, San Diego, CA, USA Department of Medicine, Division of Global Public Health, San Diego School of Medicine, University of California, San Diego, CA, USA Joint Masters Program in Health Policy and Law, San Diego School of Medicine and California Western School of Law, University of California, San Diego, CA, USA Global Health Policy Institute, San Diego, CA, USA 0000-0002-2191-7833 Journal Article 2015 12 14 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. https://www.ijhpm.com/article_3154_fdbd31f2027f20378b1a80125fc862db.pdf