V-Fluence Addresses Challenges of Facing Up to FDA Social Media Scrutiny
Scrutiny could result in pharmaceutical companies pulling back from social media arena
Saint Louis, MO (PRWEB) August 12, 2010
v-Fluence Interactive Director and health and pharmaceutical policy practice team lead Shae Johnson provides a commentary on the evolving regulatory environment for social and other digital media. Excerpts include:
The U. S. Food and Drug Administration (FDA) recently cautioned Novartis Pharmaceuticals (http://www. fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf)]for its use of a Facebook widget (and associated meta data), which was intended to educate consumers about its leukemia drug Tasigna. Similar to recent actions taken by the FDA (http://www. fda. gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773), this warning letter has been widely reported on a range of news sites and blogs and has lit up robust discussion in social media and topic-specific channels. While FDA’s move should come as no surprise to those following the evolving regulatory environment for social and other digital media, it is disappointing nonetheless.
Not only does it suggest that regulators lack an understanding of how consumers use the Internet to find and act on health information, it reveals a continued tactic-by-tactic approach to enforcing pharmaceutical marketing regulations. FDA’s continued application of old broadcast tactics and rules to narrowcast environments, and limiting that application to one set of players in those environments, puts consumers increasingly at risk from misleading and false treatment information. Much of this false information is generated by “opportunistic feeders,” such as litigators and snake oil salesmen, whose online tactics are not given similar regulatory scrutiny (see (http://www. fda. gov/downloads/AboutFDA/CentersOffices/CDER/UCM194664.pdf) v-Fluence FDA testimony on social media for additional information).
At v-Fluence Interactive (http://www. v-fluence. com/), our dedicated health practice team members undergo up-to-date training in government regulatory requirements and industry standards on issues ranging from adverse event reporting to off-label promotions. Our approach of blending topic expertise with technical understanding of how digital media works helps ensure compliance, whether it be simple brand social media monitoring or execution support for complex new media outreach initiatives.
Full blog post available here (http://www. v-fluence. com/blog/468/challenges-of-facing-up-to-fda-social-media-scrutiny).
About Shae Johnson:
Author Shae Johnson (http://www. v-fluence. com/about/team/shae-johnson) leads the v-Fluence Interactive health and pharmaceutical policy practice team. v-Fluence uses topic-dedicated analysts and digital tactic experts to provide industry-specific counsel and online execution support with topic and therapeutic area monitoring, website and digital resource evaluations and Internet environment analyses.
About v-Fluence Interactive:
With locations in San Diego, St. Louis, Boston, Chicago and Washington, DC, v-Fluence provides major brands and organizations the online analytics, strategy development and execution support they need to be measurably successful on the Web. For more on the company, visit http://www. v-fluence. com (http://www. v-fluence. com).
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