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Nov. 19, 2009
#SMHC
Navigating Regulatory
Issues of
Social Media in
Healthcare
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Today’s Speakers
Larry WeberChairman
Digital Influence Group andRacepoint Group
Michael MantheiPartner
Holland & Knight
Joe ShieldsProduct Director, Consumer Marketing
& Strategy IntegrationPfizer
Marc ReislerPartner
Holland & Knight
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Agenda
• Larry
• Joe
• Michael and Marc
• Q&A – type in your questions for the panel
#SMHC
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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
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A global law firm with one of the largest Health Law & Life Sciences Practices
in the U.S.
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Introducing Larry Weber
Chairman
Digital Influence Group and
Racepoint Group
@thelarryweber
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61% of U.S. Adults Look Online for Health Information
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Ask a health professional, such as a doctor
Sources of information American adults turn to for information or assistance in
dealing with health or medical issues:
86%
Ask a friend or family member
68%
Use the Internet
57%
Use books or other printed reference material
54%
Contact their insurance provider
33%Source: Pew Internet & American
Life Project 2009
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Impact of Online Health Information
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Affected a decision about how to treat an illness or condition
60%
Changed their overall approach to maintaining their healthor 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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The Problem
Current regulations
treat web same as
offline media
Manufacturers
reticent to engage
online
Public is deprived
access to valuable
information online
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Understanding Search
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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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Introducing Joe Shields
Joe Shields
Product Director, Consumer
Marketing & Strategy Integration
Pfizer
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Overcoming
Pharma’s Social
Awkwardness
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Socially Awkwar d
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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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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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Free vs. Regulated Speech
FDA / DDMAC
FTC1st
AMENDMENT
�
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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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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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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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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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will u still friend me tomorrow?
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Engagement Is not Optional Anymore
Pharma has a
• RIGHT to engage
• NEED to engage
• RESPONSIBILITY to engage
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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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Introducing Michael Manthei and Marc Reisler
Michael MantheiPartner
Holland & Knight
Marc ReislerPartner
Holland & Knight
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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 RulesCreate, influence or control communication
about a product
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Control Continuum
• User generated
• Real time
• No internal review
• Third party sites
• Company Generated
• Internal review
• Form 2253
• Full review and edit
of user content
No Control Full Control
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The Awkward Question
• 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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Is mere ownership of social media site enough to trigger FDA authority?
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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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Nov. 2009 Social Marketing Hearings
Purpose: “Gather testimony and written comments intended to help guide the FDA in making policy decision on the promotion ofregulated 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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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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HOMOCIDAL LUNATIC
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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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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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Discussion and Q&A
Larry WeberChairman
Digital Influence Group andRacepoint Group
Michael MantheiPartner
Holland & Knight
Joe ShieldsProduct Director, Consumer Marketing
& Strategy IntegrationPfizer
Marc ReislerPartner
Holland & Knight
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Additional Resources
• To get a copy of our white paper on “Navigating Regulatory Issues of Social Media in Healthcare”
• Email: [email protected]
• 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 [email protected]
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