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Best Practices for Promotional Content Review

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Improving cross-functional review of promotional content in Medtech and Life Sciences companies.

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Best Practices for Promotional Content Review

  1. 1. RAPS Webcast 29 September 2010Best Practices for Promotional Content Review Good Promotional Practices Series www.goodpromotionalpractices.com (90 min)
  2. 2. Agenda• Housekeeping & Introductions (5 min)• Best Practices for Promotional Content Review – What is GPP? (10 min) – Criticality of Now for GPP (5 min) – PACE: A Four-Step Process (30 min) – SOPs for GPP (10 min) – Case Study: Tradeshow Prep (10 min)• Questions and Answers (15 min)• Closing Remarks (5 min)
  3. 3. Housekeeping• Audience muted – Minimize distractions• Submit questions• Address questions during Q&A• Poll questions throughout
  4. 4. Speaker Introductions• Elsa Chi Abruzzo – President/CEO, ARAC LLC• Maureen A. Shaffer – President/CEO, Mingletoe LLC • (then Vice President, Life Sciences, Prolifiq)
  5. 5. What is GPP? Maureen ShafferVP, Life Sciences, Prolifiq (10 min)
  6. 6. Good Promotional Practices• Written & Oral Promotion = Labeling Design Control GMP GPP Human Factors
  7. 7. Systematic Content CreationDesign Control Content CreationFunctional specification Project briefConcept to launch Concept to launchDesign reviews at critical stages Project reviews at critical stagesRisk analysis Risk analysisCross-functional team Cross-functional team
  8. 8. Systematic Content ControlGMP Content ControlInternal Procedures Internal and Field ProceduresDHR CHR: Content History RecordTraceability to Customer/Patient Traceability through Sales to Customer/PatientTraining of tightly controlled staff Training of global field personnelMonitoring Monitoring in field with customersCAPA RAMP, ala Pfizer
  9. 9. Human Factors for ContentHuman Factors Content EnvironmentWho PersonasWhen Traceability to Customer/PatientWhere TrainingHow MonitoringTesting CAPA Human factors is the science and the methods used to make devices easier and safer to use. The Human Factors team advances the FDA’s patient safety mission by distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. We work with manufacturers to help ensure the application of Human Factors engineering to the design of new products. We also help device users through identification and investigation of use-related errors.
  10. 10. Forget Compliance. Think Environment.• If device operation is overly complex or counter- sales compliance intuitive, safe and efficient use of a medical product content can be compromised. Both CDRH databases and research findings indicate that lack of attention to human factors during product development may lead content to errors that have the potential for patient injury, or company fines even death. The application of user interface design CIAs principles and participation of healthcare practitioners sales and field personnel in design analyses and tests are very important. content use
  11. 11. Sales Environment
  12. 12. Poll Question• After communications are approved, do you have a system to monitor the use of these communications in the field down to the customer level? – Yes – No – Working on it – Don’t know
  13. 13. Criticality of Now for GPP Maureen Shaffer VP, Life Sciences, Prolifiq (5 min)
  14. 14. 9%!! Honesty Rating 9% trust
  15. 15. More Regulation• Levels – State, Federal, Association, Global• Specificity – FDA Good Reprints Practice• Breadth – Medical Device = Pharma = Biotech • Presenting Risk Information FDA draft • Good Reprints FDA guidance
  16. 16. Enforcement Heat Nets $1.6BIn 2009, the government:• 1,014 new criminal healthcare fraud investigations• 1,786 potential defendants• 583 convictions for healthcare fraud• Commenced 886 civil healthcare fraud investigations• Won or negotiated approximately $1.63 billion in judgments or settlements.
  17. 17. FBI Techniques• “…we will be more targeted, more creative, and more strategic in where and how…” – Utilizing data and intelligence – Going undercover• “We are especially concerned about increased disparity in white-collar sentencing.” – Seeking mean prison sentence of 45 months for company employees
  18. 18. Individual Liability• Allergan Board – Sued by pension fund two days after $600M HHS settlement announced• Spectranetics CEO, VP and Manager – And, external company hired by Spectranetics• Stryker sales reps – Back door into companyDOJ’s 2011 goal is 90% of investigations“favorably resolved”
  19. 19. Recent CIAs Point the Way• Tracking database – Substantive requirements – e.g., VT law• RAMP – “First-class software blessed by HHS”, Giampetruzzi• Monitoring triggers – e.g., high volume of purportedly unsolicited requests• Practical Compliance Advice: Recent CIAs – www.prolifiq.net/lifesciences – www.ebglaw.com in articles section
  20. 20. Speed of Light• Real-time search engines – Google Instant – Collecta – 1 second lag scanning social media sites, blogs and web• Lightning fast action/crisis response plans – During Domino’s 2 day lag, nearly one million people viewed the videos on YouTube
  21. 21. Poll Question• Is social media review, e.g. Facebook posts, tweets and LinkedIn group discussions part of your company’s current Promotional Review SOPs? – Yes, and it is adequate – Yes, and we need to revise – No – Working on it – Don’t know
  22. 22. PACE: A Four-Step Process Elsa Chi Abruzzo President, ARAC, LLC (20 min)
  23. 23. What is PACE?Prepare Analyze Categorize Execute
  24. 24. Prepare1. Obtain cross-functional executive approval2. Establish cross-functional content review committee – Strategic Governance Structure with CCO Oversight and/or, Tactical Cross-Functional PRC – SOP with objective criteria with approval form containing how and where this will be used – Regularly scheduled meetings3. Broaden purview to increase branding and compliance – Solicit materials for review, including at the concept stage – Convince company employees broadly to submit materials for review Prepare Analyze Categorize Execute
  25. 25. Promotional Review Committee • A permanent organizational unit • Composed of executives with approval authority • Adopt a content life cycle approach, with oversight from concept through execution • Apply systematic approachRecommendation #2:Create a PRC to align the organization and support execution
  26. 26. Poll Question• Does your company have a cross- functional review committee(s) with regular team meetings to review and discuss promotional content? – Yes – No – Working on it – Don’t know
  27. 27. Analyze1. What are claims made2. Compare claims against marketing standards book – time basis for updating3. Which indications allowed4. Geographical rule sets – Federal/OUS, State, Local/Hospital or OUS: EU, Pac Rim, LA5. Company Guidelines6. Ethical/Public Opinion: Fair balance, transparencyAssume rapid dissemination to competitors, FDA et al. Prepare Analyze Categorize Execute
  28. 28. Primary Filters1. Must be truthful and non-deceptive2. Must have evidence to back up claims3. Cannot be unfair4. Risk Communication Guidance5. Fair and balanced6. Transparency
  29. 29. Categorize1. Associate material with appropriate category a. Examples: General Promotional (G), Clinical Trial (C), Unapproved Use Journal Articles (Good Reprint Practices) (R), Unsolicited Requests (U), Disease Awareness (D), Internal Use Only (I) b. Include categorization in PRC form, SOP and final approved material code c. Category is approved along with the material2. Category drives rules = Consistency a. Disclaimers, risks, indications, approved labeling b. Author and study funding disclosures for reprints c. Approval routing for review of clinical trial content d. Data collection for unapproved use reprint requests Prepare Analyze Categorize Execute
  30. 30. Today’s Business Environment• On vs. off-label is complicated – Indications + Claims – Physicians choose use – Industry must find non-burdensome way to responsibly provide information• Off-label physician use – AF, Ortho/Bone protein, Peds – Requires industry cross-functional rigor and control
  31. 31. Poll Question• There are many ways to disseminate scientific materials legally in the US. Is your company using the FDA Good Reprint Practices guidance for any dissemination? – Yes – No – Working on it – Don’t know
  32. 32. Execute1. Educate and train across and up and down a. Document training and certification2. Audit and monitor sales behavior a. Regulations, CIAs3. Monitor customer usage and close-loop learning to improve materials4. Listen, modify and repeat Prepare Analyze Categorize Execute
  33. 33. Controlled Dissemination• Manual fulfillment – frequent updates? – Annual training – will they remember? – Medical Affairs – low on resources?• Intranet – how often do reps log in?• Digital CMS – Make the complex simple with technology – Efficiency and cost-savings with processes – Two choices • Modify non industry-specific with compliance rules • Choose industry-specific with compliance rules
  34. 34. Real-Time Monitoring • Retrieve quickly • Confident • Comprehensive • Pinpoint individuals, recipients, geography, products Competition, FDA or other external inquiriesRx Compliance Report, Vol.VIII, Issue 7/May 5, 2009
  35. 35. Promotional Communication SOPs (10 min)
  36. 36. Continuous Learning SOPs Laws Risk Communication Manifestation Interpretation “Permanently affixed” in Sales Environment GRP Enforcement CIAs/DPAs
  37. 37. Short List• Promotional review – Committee – Sign off form – Repository – Change control – Where stored• Claims references• Signature matrix
  38. 38. Communications– Promotional, Educational and Scientific How To • Cross-functional review team • Change Control– Promotional Risk Analysis and Mitigation Procedure • Training • Auditing and Monitoring • CAPA– Social media, PR, Facebook, Twitter
  39. 39. Case Study: Meet H2FMedCompany: H2FMEDDevice: Drizzle infusion catheterContext: US-based tradeshow for interventional radiologistsApprovals/Clearances: Class II 510(k) productIndication: Indicated to infuse various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with respective manufacturers instructions for use.
  40. 40. Case Study: Tradeshow Preparation (10 min)
  41. 41. Holistic Review: Net Impression
  42. 42. Tradeshow Plan• Pre-meeting emails/mailings• Non-CME Symposium• Booth – Videos and Graphics – At-show collateral and emails – New Products Uncleared• Collateral, print and digital• Door drops• Post-show follow emails• Advisory Board/KOL meetings• Scientific Posters• Sponsorships• Sales product training for booth duty• Training materials
  43. 43. Final Approval
  44. 44. Concept to Launch Review
  45. 45. Post Approval Considerations• Training the sales force• Build compliance into sales processes• Validate that approved content is properly managed• PRC retains visibility to use of content – Communications History Records
  46. 46. Questions & Answers• Elsa Chi Abruzzo, President/CEO, ARAC LLC – abruzzorac@gmail.com• Maureen Shaffer, President/CEO Mingletoe LLC – maureen.shaffer@gmail.com – http://www.linkedin.com/in/maureenashaffer – http://twitter.com/maureenshaffer
  47. 47. Takeaways• Downloadable presentation with audio available for a fee – raps.org• Practical CIA Takeaways – www.goodpromotionalpractices.com
  48. 48. Thank YouPlease complete a webcast evaluation located online at the link below.http://research.zarca.com/k/SsTTXYsS QXsPsPsP

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