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

5.
Display Benefits and Risks Together
If you can’t do it, don’t post!

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.
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.
FDA Warning Letter

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.
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.
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.
Agenda
• FDA Guidelines for Promotional Labeling using
Social Media with Limited Characters
– Case Study
• Iceberg Tweets
– Case Study
• Opportunities

13.
A tweet is so much
more than 140
characters

14.
Iceberg Tweeting
@craigmod Link

15.
Text

16.
Text
Date, Time

17.
Text
Photo/Video
Date, Time

18.
Text
Date, Time
Retweet
Favorite
Photo/Video

19.
Text
Date, Time
Retweet
Favorite
Individuals
Photo/Video
Replies

20.
Hashtag
Quote Tweet

21.
Tag

22.
Tweetstorm (pork.io)

23.
Metadata
“Invisible data”

24.
Summary Card Summary Card
(Large Photo)

25.
Photo Card Panel Card

26.
Player Card Product CardApp Card

27.
No risks outlined on the
Youtube Twitter Card metatags!

28.
Agenda
• FDA Guidelines for Promotional Labeling using
Social Media with Limited Characters
– Case Study
• Iceberg Tweets
– Case Study
• Opportunities

29.
Take advantage of the Twitter iceberg?
Use metadata?
Use images?
Use cards?
Use hashtags?
Be a good citizen on
social media?

30.
Use social media to help

31.
Tap into hashtag trends

32.
Throwback Thursday!

33.
http://twittersuperuser.com/
http://www.doctorasdesigner.com/
joyclee@umich.edu