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FDA Social Media Review From Dose Of Digital

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A handful of new information came out at the FDA pharma social media hearings, but quite a bit was missing as well. Here's my brief overview of what I learned and what I thought was missing

Published in: Business, Technology

FDA Social Media Review From Dose Of Digital

  1. 1. Three Things I Learned at the FDA Hearings and Three I Wish I Had Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital @jonmrich
  2. 2. Yes, I was there...
  3. 3. ...along with 60+ of my close friends
  4. 4. Two themes What I learned What I didn’t (but wish I had)
  5. 5. What I learned <ul><li>The FDA gets it </li></ul><ul><li>MedWatch is dead </li></ul><ul><li>Consumers might actually want us there </li></ul>(a serious AE, BTW)
  6. 6. What I didn’t <ul><li>FDA’s plan for keeping up </li></ul><ul><li>The end of red herrings </li></ul><ul><li>What pharma REALLY wants to do </li></ul>
  7. 7. What I learned <ul><li>The FDA gets it </li></ul><ul><li>MedWatch is dead </li></ul><ul><li>Consumers might actually want us there </li></ul>
  8. 8. The FDA gets it
  9. 9. The FDA gets it <ul><li>“ Since the 1996 public meeting, there has been a massive expansion of new tools and technologies, such as blogs, microblogs, podcasts, social network sites (‘social networks’) and online communities, video sharing, widgets, and wikis...” </li></ul>
  10. 10. The FDA gets it <ul><li>For what online communications is pharma accountable? </li></ul><ul><li>How can pharma follow the rules in using tools with space limitations and real-time comms? </li></ul><ul><li>What rules apply to the posting of corrective info on websites controlled by third parties? </li></ul><ul><li>When is the use of links appropriate? </li></ul><ul><li>Questions specific to Internet adverse event reporting </li></ul>
  11. 11. MedWatch is dead
  12. 12. MedWatch is dead Courtesy of Ignite Health
  13. 13. MedWatch is dead
  14. 14. Consumers might actually want us there <ul><li>AGREE that healthcare companies’ use of social media... </li></ul><ul><li>...provides important updates on products and services – 79% </li></ul><ul><li>...brings accurate information into conversations about drugs or devices – 73% </li></ul><ul><li>...addresses frequently asked questions about products and services – 66% </li></ul><ul><li>...adds valuable professional expertise to the conversation – 62% </li></ul>Good News
  15. 15. Consumers might actually want us there If I double the dose, would the blisters go away faster? Double your dose and see what happens, but I wouldn’t hold my breath.
  16. 16. Consumers might actually want us there <ul><li>AGREE healthcare companies... </li></ul><ul><li>...should monitor and correct misperceptions or misinformation when that info can be harmful – 90% </li></ul><ul><li>...should be responsible for policing any unauthorized versions of their content – 64% </li></ul>Bad News
  17. 17. Consumers might actually want us there <ul><li>In short... </li></ul><ul><li>To whom much is given, much is expected. </li></ul>
  18. 18. What I didn’t <ul><li>FDA’s plan for keeping up </li></ul><ul><li>The end of the red herrings </li></ul><ul><li>What pharma REALLY wants to do </li></ul>
  19. 19. FDA’s plan for keeping up
  20. 20. FDA’s plan for keeping up
  21. 21. FDA’s plan for keeping up
  22. 22. FDA’s plan for keeping up
  23. 23. FDA’s plan for keeping up 1996 2022 2009 FDA Technology-Related Hearings Schedule
  24. 24. FDA’s plan for keeping up 1996 2022 2009 FDA Technology-Related Hearings Schedule
  25. 25. The end of red herrings Only 1 in 500 posts qualifies as a “reportable adverse event”
  26. 26. The end of red herrings Source: Nielsen BuzzMetrics, Personal Communications Nielsen BuzzMetrics total Healthcare discussions (~1,350 sites): 82,697 per day Percentage of posts with a reportable adverse event: 0.2% Number of reportable adverse events for the ENTIRE INDUSTRY : 166 per day
  27. 27. The end of red herrings <ul><li>Adverse event reporting </li></ul><ul><li>Off label discussions </li></ul><ul><li>Personal identifying information </li></ul><ul><li>Monitoring volume and resources </li></ul><ul><li>FTC regulations </li></ul><ul><li>Technology integration </li></ul><ul><li>No clear precedents </li></ul><ul><li>Lack of internal expertise </li></ul>
  28. 28. The end of red herrings
  29. 29. What pharma REALLY wants to do ?
  30. 30. What pharma really wants to do ?
  31. 31. What pharma really wants to do ?
  32. 32. What pharma really wants to do ?
  33. 33. What pharma really wants to do ?
  34. 34. What pharma really wants to do <ul><li>For what online communications is pharma accountable? </li></ul><ul><li>How can pharma follow the rules in using tools with space limitations and real-time comms? </li></ul><ul><li>What rules apply to the posting of corrective info on websites controlled by third parties? </li></ul><ul><li>When is the use of links appropriate? </li></ul><ul><li>Questions specific to Internet adverse event reporting </li></ul>
  35. 35. What pharma really wants to do <ul><li>Does allowing additional leeway for pharma to participate in social media improve or harm public health? </li></ul>
  36. 36. Three Things I Learned at the FDA Hearings and Three I Wish I Had
  37. 37. Contact Me <ul><li>Text Healthcare to 50500 </li></ul>
  38. 38. <ul><li>Jonathan Richman </li></ul><ul><li>513.253.1295 </li></ul><ul><li>[email_address] </li></ul><ul><li>Twitter: @jonmrich </li></ul><ul><li>This presentation: http://bit.ly/ dodfda </li></ul><ul><ul><ul><li>http://www.doseofdigital.com </li></ul></ul></ul><ul><ul><ul><li>http://www.bridgeworldwide.com </li></ul></ul></ul>Contact Me

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