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8 Int'l. In-House Counsel J. 1 (2014-2015)

handle is hein.journals/iihcj8 and id is 1 raw text is: International In-house Counsel Journal Vol. 8, No. 29, Autumn 2014, 1 Being Social: The FDA Pronounces on Interactive Promotional Media MARIANNE SLIVKOVA Senior Corporate Counsel, Bristol Myers Squibb, USA In the United States, consumers are increasingly turning to social media to obtain information about pharmaceutical products and devices, to research medical conditions, and obtain information about potential treatments, available support groups and other health-related information. Data from Manhattan Research (for the year 2013) indicates that social media influences the patient journey in unprecedented ways: for example, upwards of 20% of consumers surveyed were strongly influenced by social media when experiencing symptoms, after diagnosis, or when managing their condition. Social media has also influenced patients' interactions with their doctors: 27% of consumers using social media reported that they asked a doctor to prescribe a generic instead of a brand as a result of health/medial information they found on-line, 12% asked a doctor to prescribe a brand, and 25% asked a doctor to prescribe any drug. It is then no wonder that the potential of social media has attracted the attention of pharmaceutical companies. However, pharmaceutical companies have been operating in the social media space largely devoid of guidance from the Food and Drug Administration (FDA). The FDA has directed companies to existing regulations regarding the promotion of pharmaceutical drugs and devices, taking the position that, regardless of the media by which information is supplied by pharmaceutical or device companies, the traditional rules of promotion apply. The FDAs enforcement during the last decade has largely echoed this position, and warning or untitled letters issued by the FDA with respect to companies' promotion within the social media sphere largely focused on violations that could take place in any media, rather than the challenges presented by social media specifically'. There were a few exceptions to this however, starting with the FDA's issuance in 2009 of 14 untitled letters to companies regarding the one click rule --namely the pervasive practice within the pharmaceutical industry of placing risk information in sponsored advertisements one click away from the promotional information. In this series of warning letters, the FDA made it clear that the one click rule was not one endorsed by the FDA and also that this rule did not fit squarely into the traditional rules of promotion. Space constraints within sponsored ads notwithstanding, the FDA required that relevant Important Safety Information (ISI) be included and the Prescribing Information (PI) be likewise made available. The effect of these letters was that companies largely ceased doing branded sponsored advertisements (i.e advertisements which mention the name of the product and the use of the product) and restricted themselves mainly to unbranded advertisements or reminder advertisements (that is, advertisements which mention only the name of the product but do not contain or suggest the product's indication, or any claims about the product). i See e.g. Gilead Sciences (2014); Institut Biochemique (2014); Oasis Consumer Healthcare (2013); Big Mountain Drugs (2013);Quincy Bioscience (2012); AMARC Enterprises (2011); Novartis (2010) ISSN 1754-0607 print/ISSN 1754-0607 online International In-house Counsel.7ournal