With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.

1. Regulating a
Social World
Presented by Dale Cooke
July 18, 2013

2. The views and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to Drug
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2www.diahome.orgDrug Information Association

3. SOCIAL MEDIA IN HEALTH

4. Consumers either creating or consuming content on or in health blogs,
message boards, chat rooms, health social networks, health communities,
and patient testimonials.
109 million U.S. adults are creating or
consuming health-related UGC online
Source: ePharma Consumer® v9.0
Source: Manhattan Research Cybercitizen Health®
v7.0‐v12.0
Especially patients with
rare diseases
Much of their rare-disease
patient interaction happens
online by necessity, since they
are unlikely to live near the
people who share their
conditions
Source: Pew Internet & American Life Project, Peer‐to‐Peer Healthcare,
February 2011

5. Use of social media for health peaks when patients are recently diagnosed
The patient journey also plays a role in
interaction with social media
18%
18%
17%
33%
2%
4%
11%
12%
37%
37%
40%
67%
15%
18%
25%
35%
Health blog
Health message boards or communities
Patient testimonials
Health ratings or reviews
Twitter
Google Plus
YouTube
Facebook
Diagnosed with a chronic condition in past 3 months
Have a chronic condition but diagnosed more than 1 year ago
Health‐specific
social media
General social
networks
Among online consumers
Source: Manhattan Research, Cybercitizen Health® U.S., 2012
Online resources used for health
in past 12 months

6. FDA GUIDANCE ON SOCIAL MEDIA

7. What we have received…
For more info on these guidances, see http://www.scribd.com/dale_cooke/documents

8. Guidance for Industry
The Bible of How to Use
Social Media Compliantly
…what we won’t get

9. RELEVANT FDA ENFORCEMENT
ACTIVITIES & THEIR IMPLICATIONS

10. Google search ads

11. Reminder Advertising
Three seemingly acceptable formats
Disease Awareness to Disease Awareness Advertising
Redirects (Unbranded to Branded Content)

12. Date: July 29, 2010
Violations
• Unsubstantiated superiority claim
• Didn’t submit 2253
• Didn’t include risk information
Lessons
• Social media is OK if done correctly
• Subpart H does NOT restrict
content or media
• Pharma is responsible for all (and
only) content they make accessible
Facebook sharing for
Tasigna from Novartis
For more info on this action, see http://www.scribd.com/dale_cooke/documents

13. Date: May 5, 2011
Violations
• Omission of risk information
• Didn’t submit 2253
• Misleading claims
Lessons
• EVERYONE needs a social media policy
• Well-intentioned employees put themselves
and the company at risk
• Must include risk information with the
benefit claims
YouTube video for
Atelvia from Warner Chilcott

14. Key Requirements
– Product Name Usage
– Fair Balance
– Indication Statement
– Adequate Provision
(Directions for Use)
– MedWatch Statement
Four Types of Communication
– Reminder Ads
– Product Promotions
– Disease Awareness
Communications
– Redirecting Communications
Regulatory implications

15. ADDRESSING THE UNIQUE
CHALLENGES OF SOCIAL MEDIA

16. • Responsiveness
• Dealing with AEs
• 2253 Filing Requirements
Unique challenges for social media

17. Establish a decision tree

18. Make use of boilerplate responses

19. 3 layers of moderation and filtration
Software
Keyword Blocklist
Human Moderation
Services
Our 1st Line of
Defense
Our 2nd Line of
Defense
Our 3rd Line of
Defense
Social Platform
Native
Keyword
Blocklist and
SPAM filter

20. MAKING SOCIAL MEDIA
OPERATIONAL

21. Governance & policy development
Governance
Determining the rules of engagement and the roles
and responsibilities among the various stakeholders,
including who owns policy development, enforcement, etc.
Policy Development
Conducting a gap analysis on existing policies,
achieving stakeholder input, and establishing
procedures for policy rollout and updates
Employee Efforts
• Protect the company
• Protect employees
• Foster a spirit of innovation
Company Efforts
• Ensure a consistent voice
• Establish standards & best
practices
• Enable speed to market
• Avoid duplicative efforts
• Document & share successes

22. > Conduct training sessions
• Provide examples of permissible and impermissible
activities
> Incorporate the policy into new employee onboarding
> Designate a social media ombudsman to answer
questions
> Use social media for something
• Establish a Facebook page for corporate
announcements
• Use an internal Twitter feed for employee news
> Regularly review/update the policy
Keys to successful policy rollout

23. > Medical-legal-regulatory review process
> Adverse event reporting
> Media relations activities
> Call center scripts & training
Leveraging and modifying existing systems

24. > Making a commitment to responsiveness
> Acknowledging the need for speed
> Setting the expectations
> Recognizing the specs
Streamlining the review & approval process

25. Questions?
Dale Cooke
Dale.Cooke@DigitasHealth.com
@PhillyCooke on Twitter
www.scribd.com/Dale_Cooke

26. About the presenter:
Dale Cooke, VP/GD, Regulatory, Digitas Health
Dale Cooke is the head of Regulatory for Digitas Health. He has worked with
more than 25 pharmaceutical and medical device clients and with Medical-
Legal-Regulatory committees around the world from offices in Philadelphia,
New York, Boston, and London. Dale advises clients on FDA enforcement
actions and provides recommendations for compliance with FDA regulations,
with a focus on issues involving the Internet and emerging technology. His
insights have been featured in the Wall Street Journal’s Health blog, The
Pink Sheet, MedAdNews, PharmExec, and others. Dale is a member of the
Drug Information Association (DIA), Regulatory Affairs Professionals Society
(RAPS), and the Food and Drug Law Institute (FDLI).
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to
speak at industry conferences on topics including FDA enforcement trends,
best practices for review processes, global review practices, and
pharmaceutical involvement in social media.
Dale earned his B.A. in Philosophy from Southern Methodist University and
an M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health.