1. Social Media and Medical Device Promotion
What’s New?
AdvaMed / MTLI
Advertising & Promotion of Medical Devices
Learning Institute Program
November 7, 2012
Washington, DC
Kathleen M. Sanzo
Copyright 2012, Morgan, Lewis & Bockius LLP ksanzo@morganlewis.com
Washington, DC

2. Audience Metrics
• Does your Company have/sponsor:
• Facebook page?
• Twitter account?
• Patient chatroom?
• Do you follow your own Company’s
Facebook/Twitter account?
• Yes
• No
2

3. Audience Metrics
• Do you have a LinkedIn profile?
• Do you have a personal Facebook page?
• Yes
• No
• Do you mention your Company on your
Facebook page?
3

4. Social Media Market Realities
4

5. What are the Market Realities?
• One in three consumers who use the internet to
research health information use social media.
• Social media ad spending is predicted to hit $8.3
Billion by 2015.*
• In a 2011 MassMedic survey of 70 medical device
companies.
• 23% said companies actively use social media
• 40% said company used it “a little but not a lot”
• 16% said no use
• 50% have social media policy
*Source: Social Media Use by Fortune 100 Companies, Burson-Marsteller, July 29, 2009.
5

6. What are the Market Realities?
• 25% of all internet time is spent on social media.
• Americans spend more time on Facebook than
any other social media site.
• Close to 40% of social media users access it
through their mobile apps.
• Internet users over 55 are driving the use of
social networking mobile apps.
• 53% of social network users follow a brand*
*Nielsen “State of the Media—Social Media Report (3Q 2011)
6

7. What are the Market Realities?
• Top 5 US social network sites, total minutes (in
billions)*
• 53,457,258 facebook
• 723,793 blogging
• 623,525 tumblr
• 565,126 twitter
• 325,679 LinkedIn
*Nielsen (2011)
7

8. What are the Market Realities?
• Patients are forming their own online support groups to
manage health conditions and information
• www.patientslikeme.com
• cancerforum.com
• www.inspire.com
• www.childrenwithdiabetes.com
• www.medhelp.org
• www.MediGuard.org
• Patients looking to rate healthcare products/services on
social media sites like Yelp!
• Patients share photos and videos, e.g., on YouTube,
Pinterest
8

9. What are the Market Realities?
• 60% of physicians are using social media to
assist medical practice-many prefer “closed
communities”
• www.sermo.com
• within3.com
• www.ozmosis.com
• www.medscape.com/connect
• www.Doc2Doc.com
• www.relaxdoc.com
• www.healtheva.com
9

10. What are the Market Realities?
• 64% of physicians have changed a treatment based on
Sermo interactions.
• Approximately 35% of high end users of Sermo would be
willing to replace activities such as KOL meetings,
conferences, poster presentations and sales reps visits with
Sermo live events.
• 74% of physicians perceive life sciences company-sponsored
educational events on Sermo to be useful.
• Even “no see” physicians would interact with life sciences
companies on Sermo.
10
• Source : Deloitte, Social networks in the life sciences industry, Dec. 14, 2010

11. What are the Market Realities?
• 24% of recently surveyed physicians use social
media daily to scan for new medical information
• 14.2% of physicians contribute to social media
sites daily for medical-related topics
• Majority of physicians are still not completely
comfortable with open social media sites
• Oncologists appear to be the highest –using sub
specialty of physicians.
*Journal of Medical Internet Research, “Understanding the Factors Influencing the Adoption and
Use of Social Media by Physicians” (Sept. 2012)
11

12. What are the Market Realities?
• AMA acknowledges benefits of social media
use:
The Internet has created the ability for medical students and physicians to
communicate and share information quickly and to reach millions of people
easily. Participating in social networking and other similar Internet
opportunities can support physicians’ personal expression, enable individual
physicians to have a professional presence online, foster collegiality and
camaraderie within the profession, provide opportunity to widely
disseminate public health messages and other health communication.
Social networks, blogs, and other forms of communication online also create
new challenges to the patient-physician relationship.
AMA Policy: Professionalism in the Use of Social Media (2012)
12

13. What are the Market Realities?
• Companies are responding to physicians and consumers by using
integrated social media campaigns including:
• blogs, microblogs (twitter),
• Patient chat rooms
• buttons and badges
• online videos
• podcasts
• social networking sites (Facebook, Sermo, Dailystrength, MomCentral)
• widgets, wikis
• Regulatory agencies like FDA and FTC engage in information exchange
through social media e.g., U.S. FDA @US_FDA ; @FDA_Drug_Info;
FDA widgets: www.facebook.com/FDA;
www.flickr.com/photos/fdaphotos
• Library of Congress archiving all tweets: 55M/day sent by Twitter.
13

14. Challenges
14

15. Challenges to Use of Social Media Sites
• Problematic third party comments
• Negative / false comments or information about product or
service
• Comments that include adverse event information
• Off-label comments
• Comments about competitor products—either inaccurate or
comparative claims that are off-label
• Frequency, speed and specificity of Company responses
• Control of employee participation and responses
15

16. Challenges to Use of Social Media Sites
• Combatting false information by third parties
about your product off your site
• E.g., Michelle Bachmann public comment about
adverse effect of Merck product Gardasil ®
• How should company correct such information in view
of possible negative public health impact?
• How far must company go to substantiate false
information?
16

17. Challenges to Use of Social Media Sites
• Spontaneous comments by third parties on company social
media site which cannot be pre-reviewed, i.e., Facebook
problem
• Possible Approaches
• Don’t participate in/sponsor Facebook or similar sites
• Allow consumers not to post spontaneous comments, but to only “like”
Company content
• Allow spontaneous comments but monitor and delete them (either through
company monitoring or auto-alert based on specified search terms; 24/7 or
less)
• Create modified Facebook-like wall which allows for pre-posting review or
create forum tabs on Facebook which redirect third party to monitored site
• Alert third parties to the review mechanisms to manage expectations about
posting policies
17

18. Challenges to Use of Social Media Sites
• Company participation in consumer-driven sites
presents special challenges
• E.g, Realself.com presents consumer comments
about and pictures of plastic surgery, and potentially
includes significant off–label discussion by HCPs and
patients
• FDA one click policy and policy on reporting AEs
which come to attention of company discourage /
create potential risk for company participation in this
type of site
18

19. Uncertainty
19

20. What will FDA’s Position be on the
Use of Social Media?
• Nobody Knows…. BUT FDA says:
• “Policy and guidance development for promotion of FDA-regulated medical
products using the Internet and social media tools are among our highest
priorities.”
• Social media guidance will address:
• Responsibility of various parties in the downstream distribution of on-line
information
• Use of links
• How to correct msinformation posted on a third part site
• Adverse event/MDR reporting
• How to present risk information in limited space, i.e., Twitter problem
• And Congress Says:
• DRAFT NEW Guidance on Social Media by June 2014 (2012 User Fee
Legislation) but no legislative hammer included (Section on 1121 of Food and Drug
Administration Safety and Innovation Act)
20

21. Why has FDA Delayed Publication of
Social Media Guidelines?
• Competing Crises.
• This is a difficult guideline to draft.
• Social media is outside of FDA’s comfort zone of
expertise.
• Social media is a messy gemish
• Abbreviated messaging to consumers and HCPs
• Social media is participatory, with parties over which FDA has no or limited
jurisdiction
• It produces real-time, rapid information which is impossible for FDA to
access, monitor, and control
21

22. FDA Enforcement Against Social Media
• Despite the lack of guidance, FDA continues to take
enforcement action against social media use, mostly
against drug promotion.
• May 2012 — Warning Letter issued to device manufacturer, ThermaSolutions
stating that video links, including clip from Grey’s Anatomy, on third party
website linked to company website, and company Twitter posts, adulterated
and misbranded the company’s device.
• February 2012 — FDA issued a large number of Warning Letters to dietary
supplement internet distributors identifying Twitter references as misleading and
changing the regulatory status of the product
• May 2011 — Warning Letter issued to Warner Chilcott based on 60 second
YouTube video made by sales rep in office of doctor because there was no risk
information included in video.
22

23. FDA Enforcement Against Social Media
• March 2011 – Warning Letter to 2035 Inc. and QLaser
Healing Light, LP based on off-label claims discussed in
embedded videos and YouTube channel.
• January 2011 – Warning Letter issued to Breast Health
Imaging Centers concerning off-label claims on
mammography in embedded videos and YouTube.
• July 2010 — Warning Letter issued to Novartis about use
of Facebook share widget because shared content did not
adequately address risks through use of hyperlink to risk
information.
23

24. What is FDA’s Current Position on the
Use of Social Media?
• FDA’s current policy--social media promotion is the
same as traditional advertising for purposes of
regulation, i.e.,
• Any reference to the product and attribute must include in the message
comprehensive information about the product’s risks
• Express and implied claims cannot be false or misleading
• Implied claims are created through use of graphics, music, color,
themes
• FDA looks at the net impression created by the promotion
• The key is to figure out how to present risk information
and limit possible modification of messages by third
parties.
24

25. What Might Affect FDA’s New Policy on
Social Media?
• 2012 Congressional Mandate
• 2012 CDRH Withdrawal of DTC Marketing
Guidance
• 2011 Draft Guidance on Unsolicited Requests
• Broad concept of “solicited” questions/comments
• Broad concept of “public” forum
• Broad concept of being “linked” to third party comments
and therefore being “responsible”
• Note PhRMA has submitted request that these guidelines
not be in lieu of specific social media guidance
25

26. What Might Affect FDA’s New Policy on
Social Media?
• 2009 FDA Draft Guidance on Presenting Risk
Information for drugs and medical devices
• The guidance states that FDA applies the same principles of risk
disclosure in advertising to all promotional pieces, regardless of
medium used.
• FDA will evaluate claims in promotion from the “reasonable consumer
acting reasonably in the circumstances standard.”
• Claims in promotion can be subject to multiple interpretations and none
of them can be misleading.
• FDA recognizes a difference between the knowledge and experience of
HCPs and consumers.
26

27. What Might Affect FDA’s New Policy on
Social Media?
• 2012 DTC TV ad review process for drugs, i.e.,
need for FDA review of substantiation for claims,
concepts and “creative themes”, and verification
of status of all HCP and consumer
endorsements/testimonials.
• March 2010 FDA proposed regulation on major
statements for DTC ads for drugs in TV and
radio.
• Major statement must be presented in clear, conspicuous and
neutral manner under FDAAA.
27

28. What Might Affect FDA’s New Policy on
Social Media?
• FDA proposed principles for risk disclosure in
DTC drug ads:
• Language must be readily understandable by consumers.
• Any audio is understandable in terms of volume, articulation, and
pacing.
• Size and contrast have to be adequate.
• There can be no distracting representations or sounds, especially if they
go to benefits of the product.
• FDA will be “flexible”.
28

29. What Might Affect FDA’s New Policy
on Social Media?
• FTC’s position on disclosures in social media--
Guidelines for determining if disclosures are clear and
conspicuous
• Both audio and text of disclaimer are necessary.
• Must be easily read—print size and contrast are important.
• No competing audio/graphics during disclaimer.
• Pacing/duration is important and risk information should be provided at
relevant times throughout ad.
• Volume, cadence, placement of disclaimer are important.
29

30. What Management Affect…
• FTC 2012 proposal to revise Dot.com Disclosure guide
for digital disclosures
• Context of claim matters—there cannot be a one-size fits all
disclosure, only factors to consider
• Media platforms must adapt to the law, not vice versa—some
claims just may not be able to be made on social media
• Using a hyperlink for disclosures may be acceptable but it must
be eye-catching, and its location is critical
• Disclosure icons and hashtags maybe acceptable and adequate
but the effectiveness may depend on consumer understanding
• Word of Mouth Marketing Association (WOMMA) Social
Media Disclosure Guide (August, 2012)
30

31. What Might Affect FDA’s New Policy
on Social Media
• FTC Guides Concerning the Use of Endorsements and
Testimonials in Advertising --Dec. 2009
• Apply to testimonials on social media (blogs, tweets, videos, etc).
• Must be truthful and non-misleading.
• Must reflect the typical user’s experience or if not, state what the
generally expected experience would be.
• Any relationship between the endorser and the company must be
disclosed (free goods, payment, commissions for sales, etc)
conspicuously, i.e., not through a separate link or button.
• Disclosure about compensation also applies to tweets—use #paid ad
or #ad, #paidspon.
• Corporate sponsors must have adequate training and monitoring
mechanisms in place for product claims made in social media.
31

32. The Courts’ View of FDA’s Regulation of
Advertising/Promotion
32

33. The Courts’ View of FDA’s Regulation of
Advertising/Promotion
• Product advertising and promotion is commercial speech—
it does not receive the highest level of First Amendment
constitutional protection but has some protection.
• Note – scientific/academic speech is afforded a higher level of protection
– strict scrutiny.
• Courts have articulated several principles under First
Amendment analyses for commercial speech.
• Prior restraint is presumptively unconstitutional.
• Keeping consumers ignorant of information is not an acceptable basis for
significant regulation of commercial speech.
• Disclosure often can cure concerns about whether speech can be
misleading or inaccurate.
• Courts outside of DC Circuit have restrained FDA’s power
to limit commercial speech
33

34. Social Media and Device Promotion
34

35. FDA Regulation of Social Media
for Device Promotion
• FDA regulates “labeling” of all devices, advertising for the very
small universe of restricted devices.
• FTC regulates all device advertising, which can be evidence
of new/different use and give rise to prohibited act under
FFDCA, false claim, and new regulatory filing.
• FDA extends its regulatory reach to advertising through broad
definition of “labeling,” and links between labeling and
advertising (e.g., common use of website address in both).
• Not clear if FDA considers social media labeling or
advertising.
35

36. How to Manage the Uncertainty without
FDA/FTC Guidelines
• Do you know where your “content” is?
• Responsible for content on your Company’s sponsored sites, sites it
supports, its employees’ use of content.
• “Patrol your own House” -- monitor and correct content
of third parties (HCP and consumers) on Company sites.
• Monitor sites/contacts from HCPs and consumers for
adverse event information / MDRs.
• Have a company policy on correcting misinformation of
which Company become aware—and have a corporate
policy on what constitutes “awareness”.
36

37. How to Manage the Uncertainty without
FDA/FTC Guidelines
• Carefully provide informative and
understandable risk information; evaluate ways
to link/provide information.
• Consider transparency quotient of all
messaging.
• Routinely test and document messaging impact
of social media content as defense to FDA and
private litigation.
37

38. How to Manage the Uncertainty without
FDA/FTC Guidelines
• Prepare policies for:
• Appropriate uses of social media for product promotion, and functional
responsibility within the organization for social media use.
• Physician and patient testimonials, celebrity endorsements, authorized
product placements.
• Correcting misinformation on third-party sites, and system for
documenting attempts to correct.
• Employee use of social media to promote/discuss products.
• HCP consultants’ use of social media to discuss company products.
• Privacy / other protections for use of HCP and consumer data from
social media sites.
38

39. How to Manage the Uncertainty without
FDA Guidelines
• Understand that use of social media for promotion
may evoke:
• Personnel issues
• Federal/state enforcement activity
• Competitor complaints/challenges through
FDA/NAD/Courts under Lanham Act
• Plaintiff claims/litigation.
• Check insurance coverage for economic injury from
social media activity.
39

40. Questions?
Kathleen M. Sanzo, Esq.
Copyright 2012, Morgan, Lewis & Bockius LLP
ksanzo@morganlewis.com
Washington, DC