Given the increasing importance of the Internet as a platform for pharmaceutical marketing, drug companies have called for guidance from the Food and Drug Administration (FDA). Of key concern is how marketers can fulfill the fair balance requirement within the space constraints of most social media platforms. The agency directs marketers to its administrative letters for clarity but has made no comprehensive assessment to articulate the guidance these letters offer, especially regarding areas in which the Internet differs from traditional media. This study offers such an assessment by examining all letters addressing violative Internet promotions from 1997 to 2012. The authors identify eight “principles in action,” including insight into the so-called one-click rule. These principles reveal how the FDA's thinking on online promotion has evolved since the 1997 draft guidance for broadcast direct-to-consumer advertising for prescription drugs and can complement the agency's first guidance regarding interactive promotion, released in 2014. The authors also identify areas the FDA has not addressed and offer suggestions.
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