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FDA Labeling for Medical Devices in the Age of Social Media

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My talk at the FDA Center for Devices and Radiological Health Medical Device Patient Labeling Public Workshop Sept 2015

Published in: Healthcare
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FDA Labeling for Medical Devices in the Age of Social Media

  1. 1. FDA Labeling for Medical Devices in the Age of Social Media Joyce Lee, MD, MPH Associate Professor University of Michigan Twitter: @joyclee
  2. 2. Disclosures Social Media/Web Editor of JAMA Pediatrics Google Life Sciences
  3. 3. Agenda •  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study •  Iceberg Tweets –  Case Study •  Opportunities
  4. 4. Agenda •  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study •  Iceberg Tweets –  Case Study •  Opportunities
  5. 5. Display Benefits and Risks Together If you can’t do it, don’t post!
  6. 6. Benefits Accurate and non-misleading Must include the indicated use of the product Likely to be read and understood by the ordinary individual under customary conditions of purchase and use
  7. 7. Risks Most serious risks Hyperlink to more information about risks (necessary but not sufficient) Presented with a prominence and readability reasonably comparable to claims about drug benefits
  8. 8. FDA Warning Letter
  9. 9. “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com
  10. 10. Omission of Material Fact Did not provide information about it’s full approved indication No studies or indication for women with hyperemesis gravidarum FDA Warning Letter
  11. 11. Omission of All Risk Information Did not list any of the major risks: Contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation, as well as in women who are taking monoamine oxidase inhibitors (MAOIs). Warnings and Precautions regarding activities requiring mental alertness and concomitant medical conditions. The most common adverse reaction was somnolence. Hyperlink unacceptable for risk communication FDA Warning Letter
  12. 12. Agenda •  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study •  Iceberg Tweets –  Case Study •  Opportunities
  13. 13. A tweet is so much more than 140 characters
  14. 14. Iceberg Tweeting @craigmod Link
  15. 15. Text
  16. 16. Text Date, Time
  17. 17. Text Photo/Video Date, Time
  18. 18. Text Date, Time Retweet Favorite Photo/Video
  19. 19. Text Date, Time Retweet Favorite Individuals Photo/Video Replies
  20. 20. Hashtag Quote Tweet
  21. 21. Tag
  22. 22. Tweetstorm (pork.io)
  23. 23. Metadata “Invisible data”
  24. 24. Summary Card Summary Card (Large Photo)
  25. 25. Photo Card Panel Card
  26. 26. Player Card Product CardApp Card
  27. 27. No risks outlined on the Youtube Twitter Card metatags!
  28. 28. Agenda •  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study •  Iceberg Tweets –  Case Study •  Opportunities
  29. 29. Take advantage of the Twitter iceberg? Use metadata? Use images? Use cards? Use hashtags? Be a good citizen on social media?
  30. 30. Use social media to help
  31. 31. Tap into hashtag trends
  32. 32. Throwback Thursday!
  33. 33. http://twittersuperuser.com/ http://www.doctorasdesigner.com/ joyclee@umich.edu

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