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
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FDA Labeling for Medical Devices in the Age of Social Media
- 1. FDA Labeling for Medical Devices in the Age of Social Media Joyce Lee, MD, MPH Associate Professor University of Michigan Twitter: @joyclee
- 2. Disclosures Social Media/Web Editor of JAMA Pediatrics Google Life Sciences
- 3. Agenda • FDA Guidelines for Promotional Labeling using Social Media with Limited Characters – Case Study • Iceberg Tweets – Case Study • Opportunities
- 4. Agenda • FDA Guidelines for Promotional Labeling using Social Media with Limited Characters – Case Study • Iceberg Tweets – Case Study • Opportunities
- 6. Display Benefits and Risks Together If you can’t do it, don’t post!
- 7. 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
- 8. 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
- 13. “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
- 14. 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
- 15. 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
- 17. Agenda • FDA Guidelines for Promotional Labeling using Social Media with Limited Characters – Case Study • Iceberg Tweets – Case Study • Opportunities
- 18. A tweet is so much more than 140 characters
- 21. Text
- 22. Text Date, Time
- 27. Tag
- 32. Summary Card Summary Card (Large Photo)
- 33. Photo Card Panel Card
- 34. Player Card Product CardApp Card
- 36. No risks outlined on the Youtube Twitter Card metatags!
- 38. Agenda • FDA Guidelines for Promotional Labeling using Social Media with Limited Characters – Case Study • Iceberg Tweets – Case Study • Opportunities
- 39. Take advantage of the Twitter iceberg? Use metadata? Use images? Use cards? Use hashtags? Be a good citizen on social media?
- 40. Use social media to help
- 41. Tap into hashtag trends