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FDA Labeling for Medical Devices in the Age of Social Media Joyce Lee, MD, MPH Associate Professor University of Michigan Twitter: @joyclee

FDA Labeling for Medical Devices in the Age of Social Media

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Page 1: FDA Labeling for Medical Devices in the Age of Social Media

FDA Labeling for Medical Devices in the

Age of Social Media

Joyce Lee, MD, MPH Associate Professor

University of Michigan Twitter: @joyclee

Page 2: FDA Labeling for Medical Devices in the Age of Social Media

Disclosures

Social Media/Web Editor of JAMA Pediatrics

Google Life Sciences

Page 3: FDA Labeling for Medical Devices in the Age of Social Media

Agenda

•  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study

•  Iceberg Tweets –  Case Study

•  Opportunities

Page 4: FDA Labeling for Medical Devices in the Age of Social Media

Agenda

•  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study

•  Iceberg Tweets –  Case Study

•  Opportunities

Page 5: FDA Labeling for Medical Devices in the Age of Social Media
Page 6: FDA Labeling for Medical Devices in the Age of Social Media

Display Benefits and Risks Together

If you can’t do it, don’t post!

Page 7: FDA Labeling for Medical Devices in the Age of Social Media

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

Page 8: FDA Labeling for Medical Devices in the Age of Social Media

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

Page 9: FDA Labeling for Medical Devices in the Age of Social Media
Page 10: FDA Labeling for Medical Devices in the Age of Social Media
Page 11: FDA Labeling for Medical Devices in the Age of Social Media
Page 12: FDA Labeling for Medical Devices in the Age of Social Media

FDA Warning Letter

Page 13: FDA Labeling for Medical Devices in the Age of Social Media

“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

Page 14: FDA Labeling for Medical Devices in the Age of Social Media

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

Page 15: FDA Labeling for Medical Devices in the Age of Social Media

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

Page 16: FDA Labeling for Medical Devices in the Age of Social Media
Page 17: FDA Labeling for Medical Devices in the Age of Social Media

Agenda

•  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study

•  Iceberg Tweets –  Case Study

•  Opportunities

Page 18: FDA Labeling for Medical Devices in the Age of Social Media

A tweet is so much more than 140

characters

Page 19: FDA Labeling for Medical Devices in the Age of Social Media

Iceberg Tweeting @craigmod Link

Page 20: FDA Labeling for Medical Devices in the Age of Social Media
Page 21: FDA Labeling for Medical Devices in the Age of Social Media

Text

Page 22: FDA Labeling for Medical Devices in the Age of Social Media

Text

Date, Time

Page 23: FDA Labeling for Medical Devices in the Age of Social Media

Text

Photo/Video

Date, Time

Page 24: FDA Labeling for Medical Devices in the Age of Social Media

Text

Date, Time

Retweet

Favorite

Photo/Video

Page 25: FDA Labeling for Medical Devices in the Age of Social Media

Text

Date, Time

Retweet

Favorite

Individuals

Photo/Video

Replies

Page 26: FDA Labeling for Medical Devices in the Age of Social Media

Hashtag

Quote Tweet

Page 27: FDA Labeling for Medical Devices in the Age of Social Media

Tag

Page 28: FDA Labeling for Medical Devices in the Age of Social Media

Tweetstorm (pork.io)

Page 29: FDA Labeling for Medical Devices in the Age of Social Media
Page 30: FDA Labeling for Medical Devices in the Age of Social Media
Page 31: FDA Labeling for Medical Devices in the Age of Social Media

Metadata

“Invisible data”

Page 32: FDA Labeling for Medical Devices in the Age of Social Media

Summary Card Summary Card (Large Photo)

Page 33: FDA Labeling for Medical Devices in the Age of Social Media

Photo Card Panel Card

Page 34: FDA Labeling for Medical Devices in the Age of Social Media

Player Card Product Card App Card

Page 35: FDA Labeling for Medical Devices in the Age of Social Media
Page 36: FDA Labeling for Medical Devices in the Age of Social Media

No risks outlined on the Youtube Twitter Card metatags!

Page 37: FDA Labeling for Medical Devices in the Age of Social Media
Page 38: FDA Labeling for Medical Devices in the Age of Social Media

Agenda

•  FDA Guidelines for Promotional Labeling using Social Media with Limited Characters –  Case Study

•  Iceberg Tweets –  Case Study

•  Opportunities

Page 39: FDA Labeling for Medical Devices in the Age of Social Media

Take advantage of the Twitter iceberg?

Use metadata? Use images? Use cards? Use hashtags? Be a good citizen on social media?

Page 40: FDA Labeling for Medical Devices in the Age of Social Media

Use social media to help

Page 41: FDA Labeling for Medical Devices in the Age of Social Media

Tap into hashtag trends

Page 42: FDA Labeling for Medical Devices in the Age of Social Media

Throwback Thursday!

Page 43: FDA Labeling for Medical Devices in the Age of Social Media

http://twittersuperuser.com/ http://www.doctorasdesigner.com/

[email protected]


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