Larry Weber of W2 Group, Marc Reisler and Michael Manthei of Holland & Knight and Joe Shields of Pfizer discuss the ways marketers in the health care industry can successfully navigate regulatory issues and maximize their online presence. This webinar discussed topics that are top-of-mind for health care marketers, such as: 1 - What is the FDA's position on using social media to market FDA-regulated products? 2 - What privacy issues should marketers be aware of when using social media? 3 - Who has liability for social media content? 4 - Should pharmaceutical and medical device companies have a social networking policy?

1. Navigating Regulatory
Issues of
Social Media in
Healthcare
Nov. 19, 2009
#SMHC

2. Today’s Speakers
Larry Weber Joe Shields
Chairman Product Director, Consumer Marketing
Digital Influence Group and & Strategy Integration
Racepoint Group Pfizer
Michael Manthei Marc Reisler
Partner Partner
Holland & Knight Holland & Knight
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3. Agenda
• Larry
• Joe
• Michael and Marc
• Q&A – type in your questions for the panel
#SMHC
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4. About Us
Full service digital agency that is social media at its core
A global public relations agency that helps clients harness the power of both
traditional and social media to build and protect reputation and drive business
A global law firm with one of the largest Health Law & Life Sciences Practices
in the U.S.
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5. Introducing Larry Weber
Chairman
Digital Influence Group and
Racepoint Group
@thelarryweber
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6. 61% of U.S. Adults Look Online for Health Information
Sources of information American adults turn to for information or assistance in
dealing with health or medical issues:
Ask a health professional, such as a doctor
86%
Ask a friend or family member
68%
Use the Internet
57%
Use books or other printed reference material
54%
Contact their insurance provider
Source: Pew Internet & American
33% Life Project 2009
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7. Impact of Online Health Information
Affected a decision about how to treat an illness or condition
60%
Changed their overall approach to maintaining their health
or the health of someone they help take care of
56%
Led them to ask a doctor new questions, or to
get a second opinion from another doctor
53%
Source: Pew Internet & American
Life Project 2009
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8. The Problem
Current regulations Manufacturers Public is deprived
treat web same as reticent to engage access to valuable
offline media online information online
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9. Understanding Search
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10. The Solution
• FDA should adopt policies that encourage manufacturers to provide
consumers with complete information.
– Don’t over-regulate the communications revolution of our time.
• Transparency is the key to freeing up information flow.
– Differentiate between paid and unpaid links
– Make source of information clear
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11. Introducing Joe Shields
Overcoming
Pharma’s Social
Awkwardness
Joe Shields
Product Director, Consumer
Marketing & Strategy Integration
Pfizer
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12. Socially Awkwar d
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13. Why Pharma Is Socially Awkward
• With social media, pharma is
confused about:
– Its purpose
– How the current regulations
apply
– Risks, rewards &
measurement
– How to review & approve
tactics
– The technologies
– Who internally is responsible
for managing it
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14. For Pharma, Why Be Social?
• Compliance
• Corporate comms
• Investor relations
• Media relations
• Issues management
• Product promotion
• Market research
• Customer service
• Customer demand
• Competitors
• Etc.
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15. Free vs. Regulated Speech
FDA / DDMAC
1st
FTC AMENDMENT
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16. Accountability Continuum
• QUESTIONS: How long do you invest in a new idea
before requiring at least some accountability? Where do
Social Media initiatives fit on this continuum?
No idea Proven,
repeatable
ROI
Uncertain risks Uncertain rewards
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17. Static Review & Approval Process
• The role of the Company is to
support Marketing, not the other way
around
• Yet in most cases, Marketing bends
to the MRL review & approval
process in pharma. This process
tends to be:
– Paper based
– Linear
– Slow
– Consensus & committee-based
– Risk-averse
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18. Technology Moves Faster than Guidance
• Explosion of new technologies rapidly creating buzz &
increasing scale
• Collision of mobile + search + social + immediacy
• Difficult for advertisers to know where to place their bets
• Some technologies challenge basics of regulated
communication, i.e., open text, mashups, character limits
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19. Organizational Support Varies for Social
• Doesn’t neatly fit in Marketing, Public Affairs, Investor
Relations, Media Relations, IT, Innovation, Corporate
Communications, Privacy Office or eMarketing
• Who plans, manages, staffs & pays for it?
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20. will u still friend me tomorrow?
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21. Engagement Is not Optional Anymore
Pharma has a
• RIGHT to engage
• NEED to engage
• RESPONSIBILITY to engage
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22. Navigating the Next Few Months
• Understand if & how Social
can help your business
• Figure out who in your
company is in the best
position to monitor &
manage it
• If it makes sense, pilot a few
tactics
• Be prepared to respond to
additional guidance from
FDA & internal review teams
in 2010
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23. Introducing Michael Manthei and Marc Reisler
Michael Manthei Marc Reisler
Partner Partner
Holland & Knight Holland & Knight
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24. Why the Law Makes Pharma Socially Awkward
Communication Decency Act
No provider or user of an interactive computer service shall
be treated as the publisher or speaker of any information
provided by another information content provider AND right
to filter offensive content.
FDA Labeling and Advertising Rules
Create, influence or control communication
about a product
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25. Control Continuum
No Control Full Control
• User generated • Company Generated
• Real time • Internal review
• No internal review • Form 2253
• Third party sites • Full review and edit
of user content
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26. The Awkward Question
Is mere ownership of social media site enough to trigger FDA authority?
• Entirely user generated, real time content
• Corrections
• Use of links
• Adverse Events
• What if you filter
• What if you join the conversation
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27. Avoiding the Awkward Question
• Ignore Social Media
• Grants to third party sites
• Keep it internal
• Participate, but don’t mention
products
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28. Nov. 2009 Social Marketing Hearings
Purpose: “Gather testimony and written comments intended to
help guide the FDA in making policy decision on the promotion of
regulated products using the Internet and social media tools.”
Topics:
1. Responsibility for online communications
2. How to fulfill regulatory requirements
• Space limitations
• Real-time communications?
3. Posting of corrective information on third party websites
4. Rules for use of links
5. Adverse event reporting
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29. Results: Long on Comments…
Short on Solutions
• Everyone LOVES the Internet – FDA: Yeah, we know that!
• Confirmed that companies are avoiding social media – Lilly Testimony
• Companies should never be responsible for 3d party content – No control
• Create a universal, FDA approved “Safety Symbol”
• Require hashtag in Tweets
• Roll-over and pop-up safety information
• Post NOV sponsored links are less relevant and less transparent!
– Opposite of what FDA wanted!
– Click through rates have dropped significantly
• Google proposed standard sponsored ad format
– Short “warning” is fixed – can’t be modified
– “More info” link will direct to risk information
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30. HOMOCIDAL LUNATIC
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32. Guides Concerning the Use of Endorsements and
Testimonials
Concerns
• Providing payment or other consideration for favorable posts
– Free products are consideration
• Key is disclosure of connections
– Must disclose connections between advertisers and their endorsers that
might materially affect the weight or credibility of the endorsement.
• Creating clear policies are also key:
– Policies should address disclosure
• Requiring reviewers receiving cash or other compensation to
disclose
• If receiving free products, that should also be disclosed
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33. Guides Concerning the Use of Endorsements and
Testimonials
FTC Example:
• Company participates in a blog advertising service.
• Company requests that a blogger try a new lotion and write a review
of the product on her blog.
• No specific claims about eczema, but blogger writes that the lotion
cures eczema and recommends to her blog readers with eczema.
• Company is subject to liability for false or unsubstantiated
statements.
• The blogger also is subject to liability.
• The blogger also liable if she fails to disclose clearly and
conspicuously that she is being paid.
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34. Discussion and Q&A
Larry Weber Joe Shields
Chairman Product Director, Consumer Marketing
Digital Influence Group and & Strategy Integration
Racepoint Group Pfizer
Michael Manthei
Marc Reisler
Partner
Partner
Holland & Knight Holland & Knight
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35. Additional Resources
• To get a copy of our white paper on “Navigating Regulatory
Issues of Social Media in Healthcare”
• Email: webinar@w2groupinc.com
• Webinar recording
• www.racepointgroup.com/digital/resources.cfm
• www.digitalinfluencegroup.com
• To continue the conversation, go to:
• http://healthcareandthesocialweb.ning.com/
• Other questions, contact:
• Jackie Lustig at jlustig@w2groupinc.com
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