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FDA Social Media


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"Uncertainty can be a Guiding Light"

To truly leverage the power of social networks, Pharma need to understand the principle of open innovation and learn to live with (and take) communication risk.

The FDA will never give crystal clear guidelines on social media. Their existing statements is all the real direction any compnay needs

Published in: Health & Medicine, Business
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FDA Social Media

  1. 1. PHARMA, THE FDA & SOCIAL MEDIA: Uncertainty Can Be A Guiding Light
  2. 2. “Uncertainty Can Be A Guiding Light” -U2, Zooropa 1993
  3. 3. White Blood Cell Count: 50,000
  4. 4. What I Will Address• What the FDA has said, will likely say, and is not going to say.• The business case for embracing uncertainty• 6 Misconceptions for social media• What this means for Canadian Pharma and Pharma overall• Q&A
  5. 5. First, 3 Facts:
  6. 6. Fact #1: The World is Getting Older, Faster10k x 365 x 19 years
  7. 7. Fact #2:Traditional DTC MarketingModels are losingeffectiveness
  8. 8. Fact #3:The FDA has yet to issue anythingsince Part 15 hearings.
  9. 9. FDA: what they have said, are going tosay, and are not going to say
  10. 10. FDA: What They Have Already Said.
  11. 11. What They FDA Has Said “Follow the regulations” Advise given by Tom Abrams, the head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), regarding Pharma & Social Media Feb 2011
  12. 12. What the FDA HasSaid: 1. Adverse Event information must be included in all DTC advertising materials. 2. Reports of Adverse Events must be reported if they meet 4 basic criteria. 3. Companies are required to ensure that adverse information is listed and is accurate on any site that is sponsoredby the product manfactuer.
  13. 13. 52 WarningLetters in 2010.
  14. 14. SOURCE: Eye on FDA:
  15. 15. SOURCE: Eye on FDA:
  16. 16. Only Social Media Violation in 2010: EstablishedRule
  17. 17. FDA: What TheyAre (Most Likely) Going to Say.
  18. 18. Low Hanging Fruit •What Constitutes a “Sponsored” site? •Safe Harbor for correct information (i.e. Wikipedia) • Safe Harbor for Adverse Events (does not have to monitor every single site) • Possible clarity on “One Click” Rule
  19. 19. FDA: What TheyAre Not Going to Say
  20. 20. Do Not Expect 100% Clarity The FDA will not "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter …” Tom Abrams, the Head of FDAs Division of Drug Marketing, Advertising, and Communications (DDMAC) , Feb 2011
  21. 21. Do Not Expect 100% Clarity “…DDMAC is unlikely to create a major new standard for social media…” John Kamp Director,Coalition for Healthcare Communication
  22. 22. Do Not Expect 100% Clarity “…It’s impossible to impossible? expect the FDA to offer direct guidance [on Pharma & Social Media]” Peter Pitts Director of Global Regulatory, Porter Novelli Former Deputy Commission, FDA
  23. 23. Do Not Expect 100% Clarity “The real question is whether Pharma has the will to engage, because they certainty have the ability if they choose to use it.” Peter Pitts Director of Global Regulatory, Porter Novelli Former Deputy Commission, FDA
  24. 24. The Pharma Business Case forEmbracing Uncertainty
  25. 25. “In the age of Facebook and Google, itseems there should be a better, moresystematic way of harnessing thiscommunal wisdom and cultivating thissort of medical discovery. Enter openinnovation.”
  26. 26. Past: Closed Innovation Future: Open Innovation
  27. 27. Chess: •Clear, specific, unchanging rules •Finite set of pieces •Finite Set of moves •Clear how investment can lead to victory •Largest dynamic is intellectual •No ambiguity
  28. 28. Poker: •Few basic rules, but they can be modified •Finite set of pieces, infinite set of moves •Unclear how investment will lead to victory •Largest dynamic is social, emotional •Lots of Ambiguity. Lots of Risk.
  29. 29. Past: Closed Innovation Future: Open Innovation
  30. 30. Misconceptions about theFDA & Social Media
  31. 31. Misconception #1 Social Media = Digital Advertising /
  32. 32. Misconception #2 Social Media Content =Social Media Platform / X X X X
  33. 33. Misconception #3Having a Presence in Social Media = Being Social /
  34. 34. Dialogue is at the heart of social media
  35. 35. Misconception #4 All Adverse Events Must Be Reported
  36. 36. FDA Criteria for AE Reporting 1.An identifiable patient. 2.An identifiable person reporting the event. 3.A suspect drug or biological product. 4.An adverse experience or fatal outcome suspected to be due to the suspect drug or biologic.
  37. 37. 2008 Study:Listening to Consumer in a highly regulated environment 5 500: 1 Among 500 messages analyzed, one message incorporated all four AE reporting criteria
  38. 38. # reported = 0
  39. 39. Misconception #6 The FDA is going to provide clear guidelines for every possible aspect of social media.
  40. 40. 3 Future Trends and What This meansfor Canada Pharma
  41. 41. Trend #1:Non-branded Corporate Communicationswill become the most dominant form ofPharma Social Media
  42. 42. Trend #2: Brand as publisher. BeyondCSR content shift toward non –brandededucation content
  43. 43. Trend #3:The New DTC = Direct to Customer
  44. 44. DTC: Direct to Customer •Cost of patient non-compliance = $30 Billion •Companies will focus on adherence as much as acquisition • High produced educational videos vs. hard to read drug information text • Both public facing videos (disease content) and password protected (product direct content) video. May not be consider DTC. • Same energy and production values in pre-purchase should be applied to post purchase
  45. 45. • Focus on Global Corporation Communications• Brand as publisher: Educational non-branded content• The New DTC = Direct to Customer
  46. 46. Thank You
  47. 47. Brad B McCormickGlobal Digital DirectorPorter NovelliBrad.mccormick@porternovelli.com646 662 6297@darbtx