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Navigating Regulatory
                Issues of
             Social Media in
               Healthcare




Nov. 19, 2009
  #SMHC
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



                                                                      2
                                                                          2
Agenda

•   Larry
•   Joe
•   Michael and Marc
•   Q&A – type in your questions for the panel

#SMHC




                                                 3
                                                     3
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.



                                                                     4
                                                                                  4
Introducing Larry Weber




                         Chairman
               Digital Influence Group and
                     Racepoint Group
                     @thelarryweber



                                             5
                                                 5
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




                                                                                   6
                                                                                                       6
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




                                                                                     7
                                                                                                     7
The Problem




Current regulations     Manufacturers      Public is deprived
treat web same as     reticent to engage   access to valuable
   offline media            online         information online




                                                     8
                                                                8
Understanding Search




                       9
                           9
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




                                                                  10
                                                                       10
Introducing Joe Shields


                                       Overcoming
                                     Pharma’s Social
                                      Awkwardness


            Joe Shields
   Product Director, Consumer
  Marketing & Strategy Integration
               Pfizer



                                                11
                                                       11
Socially Awkwar d




                12
                     12
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

                                    13
                                         13
For Pharma, Why Be Social?
•   Compliance
•   Corporate comms
•   Investor relations
•   Media relations
•   Issues management
•   Product promotion
•   Market research
•   Customer service
•   Customer demand
•   Competitors
•   Etc.


                             14
                                  14
Free vs. Regulated Speech




                    FDA / DDMAC




                                 1st
              FTC            AMENDMENT




                                         15
                                              15
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

                                                  16
                                                               16
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

                                         17
                                              17
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




                                                    18
                                                                18
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?




                                                      19
                                                              19
will u still friend me tomorrow?




                             20
                                   20
Engagement Is not Optional Anymore

Pharma has a
• RIGHT to engage
• NEED to engage
• RESPONSIBILITY to engage




                                     21
                                          21
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


                                   22
                                        22
Introducing Michael Manthei and Marc Reisler




         Michael Manthei         Marc Reisler
              Partner               Partner
         Holland & Knight      Holland & Knight




                                                  23
                                                       23
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


                                                    24
                                                               24
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




                                            25
                                                 25
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




                                                            26
                                                                          26
Avoiding the Awkward Question

• Ignore Social Media
• Grants to third party sites
• Keep it internal
• Participate, but don’t mention
  products




                                   27
                                        27
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


                                                                 28
                                                                      28
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

                                                                   29
                                                                              29
HOMOCIDAL LUNATIC




                    30
                         30
31
     31
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


                                                                 32
                                                                              32
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.


                                                                 33
                                                                        33
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




                                                                     34
                                                                          34
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



                                                             35
                                                                   35

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Navigating Regulatory Issues of Social Media in Healthcare

  • 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 2 2
  • 3. Agenda • Larry • Joe • Michael and Marc • Q&A – type in your questions for the panel #SMHC 3 3
  • 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. 4 4
  • 5. Introducing Larry Weber Chairman Digital Influence Group and Racepoint Group @thelarryweber 5 5
  • 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 6 6
  • 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 7 7
  • 8. The Problem Current regulations Manufacturers Public is deprived treat web same as reticent to engage access to valuable offline media online information online 8 8
  • 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 10 10
  • 11. Introducing Joe Shields Overcoming Pharma’s Social Awkwardness Joe Shields Product Director, Consumer Marketing & Strategy Integration Pfizer 11 11
  • 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 13 13
  • 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. 14 14
  • 15. Free vs. Regulated Speech FDA / DDMAC 1st FTC AMENDMENT 15 15
  • 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 16 16
  • 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 17 17
  • 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 18 18
  • 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? 19 19
  • 20. will u still friend me tomorrow? 20 20
  • 21. Engagement Is not Optional Anymore Pharma has a • RIGHT to engage • NEED to engage • RESPONSIBILITY to engage 21 21
  • 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 22 22
  • 23. Introducing Michael Manthei and Marc Reisler Michael Manthei Marc Reisler Partner Partner Holland & Knight Holland & Knight 23 23
  • 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 24 24
  • 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 25 25
  • 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 26 26
  • 27. Avoiding the Awkward Question • Ignore Social Media • Grants to third party sites • Keep it internal • Participate, but don’t mention products 27 27
  • 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 28 28
  • 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 29 29
  • 31. 31 31
  • 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 32 32
  • 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. 33 33
  • 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 34 34
  • 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 35 35