Big Pharma's Use of Social Media remains widely without regulation. Gabriel F Zambrano presented on this subject in 2011 at a national conference of medical device and drug lawyers as the "Wild West" atmosphere persisted and FDA fell behind on developing regulatory guidelines. Yet, FDA has become adept at using it to fulfill their mission.
2. Presented at
Mass Torts Made Perfect
April 14 & 15, 2011
Wynn LasVegas, Nevada
By
Gabriel F. Zambrano
www.RecallAttorneys.com
http://www.linkedin.com/in/gabrielfzambrano
Wednesday, April 20, 2011
3. Introduction To
Lurking
•Merriam Webster’s Definition:
•to lie in wait in a place of
concealment esp. for an evil intent
•to be concealed but capable of being
discovered
•to constitute a latent threat
Wednesday, April 20, 2011
7. Tobacco & Pharma
•Masters of Deception & Public
Relation Campaigns
•History Repeats Itself
•Predatory Behavior
•Contemporary Media and Mediums
•TV, Print, Radio, .www, Blogs/
Bloggers, SM, Apps, SMS, MMS
•.www used as ‘Web of Entrapment’
via digital buzz techniques
•Targeting of Generations
Wednesday, April 20, 2011
8. Tobacco & Pharma
•Major PR Campaigns
•“Total Coverage” through bombardment
and digital access
•TV,Radio,.www,MMS,SMS,Digital Media
•Celebrity Endorsements
•Generation gaps being filled and
exploited in every medium to reach
and penetrate markets for Blockbuster
results
Wednesday, April 20, 2011
12. What is Social Media?
• Social Media (“SM”)
• Facebook
• YouTube
• Twitter - 140 Character Micro-Blog
• Blogs/Bloggers
• LinkedIn (100 Million users/IPO 2011)
Wednesday, April 20, 2011
13. World Wide Web
• Paradigm Shifts Continue
• .www
• .com
• .net
• .org
• .info
• .co (Summer 2010)
Wednesday, April 20, 2011
14. Villages & Communities
• Small interconnected like minded people across the
web with mobile access
• Cloud Based for Everyone
• Cross Platform Accessibility
• PC
• MAC
• iPhone
• Blackberry
• Android
Wednesday, April 20, 2011
15. Applications (“Apps”)
• Access from Mobile Devices
• Downloaded
• iTunes
• Blackberry
• Droid
• Send & Receive Information
Wednesday, April 20, 2011
16. Cultural Norm
• “There is an App for that”
• Open Door to interaction with Pharma
product or reliance on ‘their’ message
• Part of Consumer Experience and
Environment
• Pharma Converting Net Gen Consumer
• Expectation and Customization
• M.D.’s in training/residency are targets for
brand awareness, becoming advocates or
Key Opinion Leaders (KOL)
Wednesday, April 20, 2011
17. Social Media:
Land Ruled by
The Avatar
Graphical representation of user or alter ego.
Not J. Cameron’s Avatar Nation.
Wednesday, April 20, 2011
18. Pollination of Generations
• Baby Boomer Generation (1946-1964)
• Generation X (1965-1976)
• Baby Bust
• The Net Generation (1977-1997)
• GenerationY or The Millenials
• Generation Next (1998-Present)
Grown Up Digital by Dan Tapscott
Wednesday, April 20, 2011
19. Where is the FDA
• FDA Guidance on SM
• Repeatedly Delayed
• Arguments on Delay
• Media Changing Too Fast
• Need Perceived as Limited
• Resources Already at Limit
• Significance Discounted
• FDA utilizing and finding ‘Voice’
Wednesday, April 20, 2011
20. FDA is Evolving
• FDA utilizing and finding “Voice”
• Invited comments
• Streamlining itself in recent years to
“act” faster
• Has actually embraced and is using
Social Media
• FDA is plugged into contemporary
Social Media uses
Wednesday, April 20, 2011
21. FDA Guidance
• Read Between the Lines of FDA Warning
Letters
• Legal Defense Teams for Pharma are
reading, analyzing and advising based upon
prior, or recent, action in form of Letters
• Wild West but
• Historical Precedent in Ghosts ofYears
Past
• Read the Omens
Wednesday, April 20, 2011
22. Big Brother is Watching
• There were hearings and contributions
• FDA Public Hearing on Promotion of FDA-
Regulated Medical Products Using the Internet &
Social Media Tools, 74 Fed. Reg. 48, 083, 48, 085
(September 21, 2009)
• Internet on the Radar in mid 1990’s
• Notice of Public Meeting, 61 Fed. Reg. 48,707
(September 16, 1996)
Wednesday, April 20, 2011
23. 2010 In Review
• A Letter re use of Facebook platform
• 8 PromotionalVideos Content & Format
• 13 .www, webcasts, or webbased video, e-
mail, SM
• “Oral Statements” drew FDA Ire 2x from
conference based statements
Wednesday, April 20, 2011
24. Facebook Phenomena
• The Accidental Billionaires -The Founding of
Facebook:A Tale of Sex, Money, Genius & Betrayal
by Benz Mezrich
• Did you overlook what Facebook became?
• 500 Million Users and growing
• Same idea with Pharma, Apps & SM
• Except they have been exploiting and
incorporating into campaigns for years now
• Litigators must remain vigilant and watchful of
their uses of Social Media
Wednesday, April 20, 2011
42. Omitted to Tell
• ENBREL (etanercept)
• REMS - Risk Evaluation and Mitigation Strategy
• GOOGLE results do not mention REMS either
• Actionable or Not ?
Wednesday, April 20, 2011
43. YouTube
• AstraZeneca efforts continue
• BAYER - Tried inYAZ with counseling video
• Not everyone comes out a winner using Social
Media
• Failures are public - Charlie Sheen - Twitter
• Success becomes viral - Charlie Sheen - Torpedo of
Truth Tour
Wednesday, April 20, 2011
68. NOVARTIS - TASIGNA
• Facebook Share
Widget
• Efficacy
represented w/o
any risks
• Implied
superiority
• Misbranding
• Not submitted to
FDA prior to use
Wednesday, April 20, 2011
69. NOVARTIS - TASIGNA
• Indicated for
treatment of
treatment of
chronic phase/
accelerated
Philadelphia
chromosome
positive Ph+
chronic
myelogenous
leukemia (CML) in
adult patients
resistant or
intolerant to prior
therapy that
included imatinib
Wednesday, April 20, 2011
71. 2011 SM Guidance
• Delayed as of March 2011
• UK has April 2011
• FDA Warning Letters are barometers
• Pharma Defense Firms are providing
guidance based upon Letters and Action
• Self Policing will not work
• Government Funding Meltdown will lead to
Crisis Management
Wednesday, April 20, 2011
72. Is the FDA Keeping Up?
Wednesday, April 20, 2011
73. • Mediums continue to emerge
• Viral Potential - Charlie Sheen Phenomena
- The Torpedo of Truth
• Vigilance in future litigation on uses of SM,
Third Party Advocates
• Limited Resources in Wide Open Arena
• FDA is adopting uses, experimenting,
learning, probing and using SM
• Proactive FDA skilled in SM emerging
Wednesday, April 20, 2011
74. FDA in APRIL 2011
Pro-Consumer User Friendly
Wednesday, April 20, 2011
76. History Repeats Itself
•Public Health Message Shouted Down by
Pharma Dollars
•Darwinian Environment
•Understaffed - 12, 000 Career Employees
•Underfunded
•FDA has Evolved and Using Social Media
•Morphing of Web 2.0 Technology and uses
continues
Wednesday, April 20, 2011
77. •FDA is part of the Presidential Administration not
and independent agency like SEC or FTC
•All Testimony before Congress is reviewed and
approved by White House Office of Managment
& Budget
•Pharma PR Machine is capitalizing on ability to
create, manipulate and change via digital buzz
•Plenty of work for FDA and Consumer Advocates
•“Personal Choice”
•“Customization” by Net Generation
•David & Goliath Battles Remain
Wednesday, April 20, 2011