Earlier this year, the FDA issued the first enforcement action against a pharmaceutical company for its use of a social media sharing tool in marketing a prescription drug. A notice of violation letter directed Novartis Pharmaceutical Corporation to stop disseminating allegedly misleading promotional content utilizing the “Facebook® Share” social media widget (letter posted August 4, 2010 on the FDA website).1 The letter recognizes that Novartis submitted its “website content” to the FDA, but Novartis did not submit the “shared content” that website visitors could access by clicking on the Facebook Share widget.2

Although the shared content actually was generated by the Facebook Share widget, Novartis’s website developer added the plug-in to the Novartis website and coded the meta tags and link(s) that were incorporated by the widget. The FDA determined that this content was completely controlled by Novartis because Facebook users could not modify the content.3 The drug product information ultimately posted via the Facebook widget did not include any of the required risk disclosures. The FDA found that the communication was misleading even though the shared content contained a hyperlink to appropriate drug product safety information.”4