Kim, H. (2013, August). New media, new guidelines?: FDA regulation of online DTC prescription drug promotions. Paper presented at the annual meeting of the Association for Education in Journalism and Mass Communication, Law & Policy Division, Washington, D.C.ed Item

This paper will first provide background information on the FDA’s regulation of DTC prescription drug advertising, in order to understand the FDA’s traditional role. Second, a literature review will show how scholars have looked at DTC advertising and its regulation from a wide spectrum of perspectives. A recent study examining DTC advertising on websites will also be discussed, to explain the current status of online DTC promotional activities in the light of the fair balance requirement. The paper will then analyze warning letters and untitled letters issued by the FDA to pharmaceutical companies regarding their online DTC promotional activities to assess what types of alleged violations are frequently being cited by the FDA in this context. Finally, this study will provide recommendations on how the FDA might to revise its guidelines in light of the advent of Internet media, based on the analysis of the alleged violations in warning letters and untitled letters.