DIA Webinar Regulating a Social World

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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.

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DIA Webinar Regulating a Social World

  1. 1. Regulating a Social World Presented by Dale Cooke July 18, 2013
  2. 2. The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Disclaimer 2www.diahome.orgDrug Information Association
  3. 3. SOCIAL MEDIA IN HEALTH
  4. 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. 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. 6. FDA GUIDANCE ON SOCIAL MEDIA
  7. 7. What we have received… For more info on these guidances, see http://www.scribd.com/dale_cooke/documents
  8. 8. Guidance for Industry The Bible of How to Use Social Media Compliantly …what we won’t get
  9. 9. RELEVANT FDA ENFORCEMENT ACTIVITIES & THEIR IMPLICATIONS
  10. 10. Google search ads
  11. 11. Reminder Advertising Three seemingly acceptable formats Disease Awareness to Disease Awareness Advertising Redirects (Unbranded to Branded Content)
  12. 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. 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. 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. 15. ADDRESSING THE UNIQUE CHALLENGES OF SOCIAL MEDIA
  16. 16. • Responsiveness • Dealing with AEs • 2253 Filing Requirements Unique challenges for social media
  17. 17. Establish a decision tree
  18. 18. Make use of boilerplate responses
  19. 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. 20. MAKING SOCIAL MEDIA OPERATIONAL
  21. 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. 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. 23. > Medical-legal-regulatory review process > Adverse event reporting > Media relations activities > Call center scripts & training Leveraging and modifying existing systems
  24. 24. > Making a commitment to responsiveness > Acknowledging the need for speed > Setting the expectations > Recognizing the specs Streamlining the review & approval process
  25. 25. Questions? Dale Cooke Dale.Cooke@DigitasHealth.com @PhillyCooke on Twitter www.scribd.com/Dale_Cooke
  26. 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.

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