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FDA Presentation: How Marketers Should Manage Online Adverse Event Reporting

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Presentation at the FDA Hearing on November 13, 2009 by Rohit Bhargava on how marketers should handle finding reportable adverse events online.

Presentation at the FDA Hearing on November 13, 2009 by Rohit Bhargava on how marketers should handle finding reportable adverse events online.


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  • 1. How Marketers Should Use The Internet & Social Media For Promotion AER Comments At The FDA Hearing Ogilvy 360 Digital Influence Rohit Bhargava, SVP http://blog.ogilvypr.com/tag/pharma November 13, 2009
  • 2. How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products? Presentation By Ogilvy PR 360 Digital Influence November 12, 2009 FDA QUESTION #5:
  • 3. What the current guidelines encourage marketers to do …
  • 4. Myth … Reportable Adverse Events All Conversation Online Presentation By Ogilvy PR 360 Digital Influence November 12, 2009
  • 5. Reality … Reportable Adverse Events All Conversation Online Presentation By Ogilvy PR 360 Digital Influence November 12, 2009
  • 6. THE BIG QUESTION: How far should marketers need to dig? Presentation By Ogilvy PR 360 Digital Influence November 12, 2009
  • 7. Our Point Of View
    • Brands should be responsible for reporting adverse events found online ONLY IF ALL REPORTABLITY and IDENTIFIABILITY CRITERIA are met WITHOUT any additional follow up required from the brand.
    • If these criteria are met, then the already outlined process an organization has for reporting adverse events should be instituted to handle adverse events found online.
    Presentation By Ogilvy PR 360 Digital Influence November 12, 2009
  • 8. How Marketers Should Use The Internet & Social Media For Promotion AER Comments At The FDA Hearing Ogilvy 360 Digital Influence Rohit Bhargava, SVP http://blog.ogilvypr.com/tag/pharma November 13, 2009
  • 9.
    • We identify and engage influencers and affinity groups to spark word of mouth about a brand or issue. We drive a new form of “earned media” by using social media strategically and adding scale and volume through integrated marketing and communications programs.
    • We use social content to change perceptions and influence behavior , telling the real story behind a brand in a complex legal and regulatory environment.
  • 10. Rohit is also the author of the best selling marketing book Personality Not Included , a guide for brands on using their personality for marketing, which is available in more than 50 countries around the world in 8 languages. For five years, he has also published the Influential Marketing blog, which is currently ranked among the top 50 marketing blogs in the world by AdAge magazine and was called "intellectual and educational" by the Wall Street Journal. Rohit teaches marketing and communications at Georgetown University in the Center for Social Impact and has been featured on the covers of PR Week UK and MarketingChina and been interviewed or featured in BusinessWeek, Inc Magazine, and Fast Company. He was also recently named one of the most influential South Asians working in media & marketing. LINKS: http://blog.ogilvypr.com/tag/pharma http://www.twitter.com/ogilvypr http://www.influentialmarketingblog.com http://www.twitter.com/rohitbhargava Rohit is a founding member of the pioneering 360 Digital Influence team at Ogilvy, and a member of the Strategy & Planning Group. He specializes in crafting social media & word of mouth marketing strategy for clients and has led recent work within the agency for some of Ogilvy’s largest healthcare and pharma clients. He is leads the Digital Health team within Ogilvy PR, a group focused on explaining and recommending the strategic use of social media for Ogilvy PR’s pharmaceutical clients. This includes defining conversation analysis tools that account for the specific consideration of adverse events, engagement strategies in a highly regulated environment and counseling brands on managing crisis with social media. Rohit Bhargava SVP, Strategy & Planning | Ogilvy PR 360 Digital Influence