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DIA Webinar Regulating a Social World

Dale Cooke
Dale Cooke

With the explosion of social media and its growing importance, its 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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Regulating a Social World Presented by Dale Cooke July 18, 2013
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.orgDrugInformationAssociation
SOCIAL MEDIA IN HEALTH
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速 v9.0 Source:ManhattanResearchCybercitizenHealth速 v7.0v12.0 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:PewInternet&AmericanLifeProject,PeertoPeerHealthcare, February2011
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% Healthblog Healthmessageboardsorcommunities Patienttestimonials Healthratingsorreviews Twitter GooglePlus YouTube Facebook Diagnosedwithachronicconditioninpast3months Haveachronicconditionbutdiagnosedmorethan1yearago Healthspecific socialmedia Generalsocial networks Among online consumers Source: Manhattan Research, Cybercitizen Health速 U.S., 2012 Onlineresourcesusedforhealth inpast12months
FDA GUIDANCE ON SOCIAL MEDIA
What we have received For more info on these guidances, see http://www.scribd.com/dale_cooke/documents
Guidance for Industry The Bible of How to Use Social Media Compliantly what we wont get
RELEVANT FDA ENFORCEMENT ACTIVITIES & THEIR IMPLICATIONS
Google search ads
Reminder Advertising Three seemingly acceptable formats DiseaseAwarenesstoDiseaseAwarenessAdvertising Redirects(UnbrandedtoBrandedContent)
Date: July 29, 2010 Violations Unsubstantiated superiority claim Didnt submit 2253 Didnt 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
Date: May 5, 2011 Violations Omission of risk information Didnt 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
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
ADDRESSING THE UNIQUE CHALLENGES OF SOCIAL MEDIA
Responsiveness Dealing with AEs 2253 Filing Requirements Unique challenges for social media
Establish a decision tree
Make use of boilerplate responses
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
MAKING SOCIAL MEDIA OPERATIONAL
Governance & policy development Governance Determiningtherulesofengagement andtheroles andresponsibilitiesamongthevariousstakeholders, includingwhoownspolicydevelopment,enforcement,etc. PolicyDevelopment Conductingagapanalysis onexistingpolicies, achievingstakeholderinput,andestablishing proceduresforpolicyrolloutandupdates EmployeeEfforts Protectthecompany Protectemployees Fosteraspiritofinnovation CompanyEfforts Ensure aconsistentvoice Establishstandards&best practices Enablespeedtomarket Avoidduplicativeefforts Document&sharesuccesses
> 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
> Medical-legal-regulatory review process > Adverse event reporting > Media relations activities > Call center scripts & training Leveraging and modifying existing systems
> Making a commitment to responsiveness > Acknowledging the need for speed > Setting the expectations > Recognizing the specs Streamlining the review & approval process
Questions? Dale Cooke Dale.Cooke@DigitasHealth.com @PhillyCooke on Twitter www.scribd.com/Dale_Cooke
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 Journals 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 Universitys School of Public Health.

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DIA Webinar Regulating a Social World

  • 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 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.orgDrugInformationAssociation
  • 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速 v9.0 Source:ManhattanResearchCybercitizenHealth速 v7.0v12.0 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:PewInternet&AmericanLifeProject,PeertoPeerHealthcare, February2011
  • 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% Healthblog Healthmessageboardsorcommunities Patienttestimonials Healthratingsorreviews Twitter GooglePlus YouTube Facebook Diagnosedwithachronicconditioninpast3months Haveachronicconditionbutdiagnosedmorethan1yearago Healthspecific socialmedia Generalsocial networks Among online consumers Source: Manhattan Research, Cybercitizen Health速 U.S., 2012 Onlineresourcesusedforhealth inpast12months
  • 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 wont get
  • 9. RELEVANT FDA ENFORCEMENT ACTIVITIES & THEIR IMPLICATIONS
  • 11. Reminder Advertising Three seemingly acceptable formats DiseaseAwarenesstoDiseaseAwarenessAdvertising Redirects(UnbrandedtoBrandedContent)
  • 12. Date: July 29, 2010 Violations Unsubstantiated superiority claim Didnt submit 2253 Didnt 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 Didnt 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
  • 16. Responsiveness Dealing with AEs 2253 Filing Requirements Unique challenges for social media
  • 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
  • 21. Governance & policy development Governance Determiningtherulesofengagement andtheroles andresponsibilitiesamongthevariousstakeholders, includingwhoownspolicydevelopment,enforcement,etc. PolicyDevelopment Conductingagapanalysis onexistingpolicies, achievingstakeholderinput,andestablishing proceduresforpolicyrolloutandupdates EmployeeEfforts Protectthecompany Protectemployees Fosteraspiritofinnovation CompanyEfforts Ensure aconsistentvoice Establishstandards&best practices Enablespeedtomarket Avoidduplicativeefforts Document&sharesuccesses
  • 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
  • 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 Journals 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 Universitys School of Public Health.