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Compliant Promotion in an On-demand World


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The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has …

The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance

Published in: Business, Economy & Finance

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  • 1. Compliant Promotionin an On-Demand World6 June 2013Presented byDale CookeVice President/Group Director, Regulatory Review
  • 2. 2AgendaChanging Media EnvironmentEnforcement EnvironmentDigital TacticsFDA on Social Media and the InternetFDA on Mobile AppsKey Takeaways
  • 3. 3Changing Media Environment: Consumers
  • 4. 4eMarketer TV, Web Vie forViewers’ Attention, March 2008More than 75% of the US adult Internetusers went online while watching TVIn a typical week, how many hours do you spend doing each of the following?Some of us are online more than we watch TV……and most of us go online while we watch TVSOURCE: North American Technographics®Benchmark Survey, 2009 - ConsumersBehavior Online: A 2009 Deep Dive
  • 5. 5SOURCE: North American Technographics® Benchmark Survey, 2009 -Consumers Behavior Online: A 2009 Deep DiveConsumers want — and have access to — more, fasterAmericans are increasingly onlinewith broadband accessOnlineBroadbandAll US households(millions)0204060801001201402004 2005 2006 2007 2008 2009 2010 2011 2012 2013
  • 6. 6Consumers are social67%20%15%16%13%6%33%0% 10% 20% 30% 40% 50% 60% 70% 80%FacebookLinkedInPinterestTwitterInstagramTumblrNonePew Internet: Social Networking (full detail)February 14, 2013
  • 7. 7Taking their online lives on the road
  • 8. 8Hours per week 0 5 10 15Gen Yers (18-29)Gen Xers (30-43)Younger Boomers (44-53)Older Boomers (54-64)Seniors (65+)Internet use, personal purposes88% of online adults seek health info each year,but for most it is a small part of their total online experience10%16%25%19%13%12%4%Daily > onceper week2-3 timespermonthAbt oncepermonthEvery 2-3months2-3 timesa yearYearlyFrequency of online health info seekingAmong all online adultsSOURCE: Forrester North AmericanTechnographics Benchmark Survey, 2009:Consumers Behavior Online: A 2009 Deep Dive SOURCE: Manhattan Research, The Cybercitizen Health™ v8.0 (2008)
  • 9. 9Changing Media Environment: HCPs
  • 10. 10Physicians traditional reliance on reps israpidly waning75%18%7%Call LengthMost calls today end at thesample closetAnd one in four physicianssees no reps at allOnly 55% of physicians findinformation received in salescalls valuableSOURCE: Datamonitor, 2008SOURCE: SK&A Information Services, 2009SOURCE: Datamonitor, 2007Zero < 2 Minutes ≥ 2 Minutes
  • 11. 11Doctors love their gadgetsAmong all physiciansSOURCE: Taking the Pulse® v13.0 (2013)More thanthree-quartersof physicians own asmartphone91%88%83%80%72%0% 20% 40% 60% 80% 100%Cellular or mobile phoneDesktop computerSmartphoneLaptopTabletTechnology Devices Owned or Used
  • 12. 12In less than three years, iPad has alreadyestablished a strong beachheadPhysician Tablet OwnershipiPadOther TabletNoneiPad: 55%None: 28%Other:17%Source: ePharma Physician® v13.0 (2013)
  • 13. 13Physicians are online…increasingly in the clinical settingSOURCE: Taking the Pulse® v13.0 (2013)Among tablet ownersAnd the iPad?58%56%26%23%On weekendsBefore or after workBetween patientconsultationsDuring patientconsultations14%10%51%12%5%9%0%10%20%30%40%50%60%None <1 hr 1-2 hrs 2-3 hrs 3-5 hrs >5 hrsTime Spent Using Digital Resourcesduring a Typical Workday
  • 14. 1454%17%16%10%3%3%38%0% 20% 40% 60%FacebookLinkedInGoogle+TwitterSoundCloudTumblrNone of thesePersonal use9%24%8%3%1%0%66%0% 20% 40% 60% 80%FacebookLinkedInGoogle+TwitterSoundCloudTumblrNone of theseProfessional UseDoctors are social people …but not for workSOURCE: Taking the Pulse® v13.0 (2013)
  • 15. Enforcement Environment
  • 16. 16$8.7 billion in three yearsThe HEAT is on
  • 17. 17Bad Ad Program
  • 18. 18Increase in the number of reports ofviolative promotional activities from HCPs 11SOURCE: FDA Bad Ad Program Year End Report, 2011 it successful?
  • 19. 19Future Expansion Planned
  • 20. 20Presenting RiskInformation Compliantly
  • 21. 21FDA is here to help May 2009
  • 22. 22FDA Considerations> Materiality and Comprehensiveness> Hierarchy of Risk Information> Signaling> Quantity Counts> Framing
  • 23. 23FDA ConsiderationsNet ImpressionComparablyProminent
  • 24. Draft Guidance in Practice
  • 25. 25Email for Voltaren from NovartisDate: April 14, 2010Violations:> Minimization of risk information> Overstatement of efficacy> Broadening of indicationLessons:> Reasonably comparable presentation explicated> Segregation of risk information
  • 26. 26Email for Voltaren from NovartisDate: April 14, 2010Violations:> Minimization of risk information> Overstatement of efficacy> Broadening of indicationLessons:> Reasonably comparable presentation explicated> Segregation of risk informationBenefitRisk
  • 27. 27Email for Voltarenfrom Novartis
  • 28. 28Sales Aid for Durezolfrom Sirion TherapeuticsDate: February 18, 2010Violations:> Minimization of risk information> Overstatement of efficacyLessons:> Reasonably comparablepresentation explicated> Segregation of risk informationdiscouraged> Include risk informationin all parts
  • 29. Conversion fromDisease Awareness to Product Information
  • 30. 30Journal Ad for Arzerrafrom GlaxoSmithKlineDate: April 15, 2010Violations:> Didn’t submit pre-approval> Didn’t submit 2253> Didn’t include risk informationLessons:> Heightened scrutiny for allpromotional efforts for subpart Hproducts> Mere omission of a drug name doesnot automatically make a piece“unbranded”> Use of a redirect URL does notensure compliance
  • 31. Patient Testimonials
  • 32. 32Patient Video for Herceptinfrom GenentechDate: March 26, 2010Violations:> Minimization of risk information> Overstatement of efficacyLessons:> Reasonably comparable presentationexplicated> Segregation of risk information> Minimal risk information in “body” ofvideo does NOT suffice> Pre-scroll of risk information does NOTsuffice
  • 33. 33Patient Video for Adcircafrom Eli LillyDate: January 1, 2010Violations:> Overstatement of efficacyLessons:> Patient descriptions of their conditioncan expand indication and overstateefficacy> Ensure patient experience fall withinclinical results
  • 34. Social Media
  • 35. 35Atelvia Videofrom Warner ChilcottDate: May 5, 2011Violations:> Omission of risk information> Didn’t submit 2253> Misleading claimsLessons:> EVERYONE needs a Social Media Policy> Must include risk information with thebenefit claims
  • 36. 36Facebook Sharing forTasigna from NovartisDate: July 29, 2010Violations:> Unsubstantiated superiority claim> Didn’t submit 2253> Didn’t include risk informationLessons:> Social media is OK if done correctly> Subpart H does NOT restrict content ormedia> FDA advisory comments can beignored, but doing so increases yourrisk of enforcement later
  • 37. 37FDA on Social Mediaand the Internet
  • 38. 38Nov ’09 Part 15 Hearings & FDASIAFive questions from part 15 hearings> What online communications are sponsorsresponsible for?> How can sponsors fulfill obligations inspace-limited contexts?> What should sponsors do about correctivemessaging?> When are links appropriate?> How should sponsors deal with AERs?FDASIA mandate to produce guidance by July 2014
  • 39. 39What NOT to Expect> Overturning previous enforcement actions• One-click rule is well and truly dead> Creation of new regulations> Exemptions from existing regulations
  • 40. 40What Might be Included> Discussion of the Adequate ProvisionRequirement in Space-Limited Formats> Something akin to the “major statement”requirement for broadcast advertising> Elaboration of what constitutes materialrisk information
  • 41. 41Mobile Apps
  • 42. 42Medical DevicesAdvertising & PromotionWhat is this thing?
  • 43. 43FDA is here to help July 2011
  • 44. 44MMA guidanceMobile Medical App (MMA) defined as:“When the intended use of a mobile app is for thediagnosis of disease or other conditions, or thecure, mitigation, treatment, or prevention ofdisease, or is intended to affect the structure orany function of the body of man, the mobile app isa device.”— Draft Guidance, Mobile Medical Applications, page 8
  • 45. 45Apps FDA intends to regulate as devices> Accessories to a regulated medical device> Apps transforming the mobile device into a medicaldevice> “input patient-specific information and…output apatient-specific result, diagnosis, or treatmentrecommendation to be used in clinical practice or toassist in making clinical decisions”— Draft Guidance, Mobile Medical Applications, page 14
  • 46. 46Final guidance due“in the coming weeks”—March 21, 2013Christy Foreman,Director of the Office of DeviceEvaluations, CDRH
  • 47. 47But what about mobile promotion?Unique considerations for mobile promotion> Device size> Device variability> Screen rotation> Technology changes (Go away, Flash!)> Screen takeover> Touch screen interface> Integration with the rest of the device (GPS,calendar, reminders, etc.)
  • 48. 48Key Takeaways
  • 49. 49While we’re waiting…Avoid segregation of risk information> Integrate the risk information into the body of the material> Don’t relegate the information to the footer or the backEnsure the risk information is presented in a reasonablycomparable manner to the benefit information> Benefit in audio, risk in audio> Benefit in large font, risk in large fontDon’t distract from the risk informationMake sure claims fall within the broad experience of theclinical trials> Avoid outliers in your studies as your patient testimonialsAssume draft guidance represents FDA’s current positionAny guidance will NOT change the rules
  • 50. Questions?Dale CookeVice President/Group Director, Regulatory on
  • 51. 51Dale CookeVP/Group Director, Regulatory ReviewDale Cooke is the head of the Regulatory Review department for DigitasHealth. He has worked with more than 25 pharmaceutical and medicaldevice clients and with Medical-Legal-Regulatory committees around theworld from offices in Philadelphia, New York, Boston, and London. Daleadvises clients on FDA enforcement actions and provides recommendationsfor compliance with FDA regulations, with a focus on issues involving theInternet and emerging technology. His insights have been featured in theWall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec,and others. Dale is a member of the Regulatory Affairs Professionals Society(RAPS) and the Food and Drug Law Institute (FDLI).Dale is the author of Effective Review and Approval of Digital PromotionalTactics, which is part of the FDLI primer series. He is regularly invited tospeak at industry conferences on topics including FDA enforcement trends,best practices for review processes, global review practices, andpharmaceutical involvement in social media.Dale earned his B.A. in Philosophy from Southern Methodist University andan M.A. in Analytical Philosophy from the University of Arizona and studiedEpidemiology and Biostatistics at Drexel University’s School of Public Health.Before joining Digitas Health, Dale was with ARAMARK overseeing proposaldevelopment for government and industry clients.