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Semelhante a Enhance Promotional Compliance by Improving Internal review 2013
Semelhante a Enhance Promotional Compliance by Improving Internal review 2013 (20)
Enhance Promotional Compliance by Improving Internal review 2013
- 1. Alan Bergstrom Senior Director, Commercial Regulatory Affairs CBI Promotional Compliance October 7, 2013 Enhance Promotional Compliance by Improving Internal Review
- 2. The content, views, and opinions in this presentation are my own and do not in anyway represent the views or opinions of Daiichi Sankyo, Inc.
- 3. 3 Agenda •Process •Reviewers • Roles and Responsibilities •Collaboration • Medical Affairs • Marketing •Training
- 4. 4 Process •Do you have an SOP? •Do you have an oversight committee? • Broad oversight of process • Non-product related material review • 1st line for dispute resolution •Process Owner • Marketing • Regulatory • Business Operations •Defined Escalation Process
- 5. 5 Process •Expedited Reviews •Innovation • How do you review truly significant innovative tactics?
- 6. 6 Reviewers – The Right People •Roles and Responsibilities • Are they clearly defined? •Subject Matter Experts •Solutions oriented, not just preventing risk •Emotional Intelligence
- 7. 7 Example – Legal and Regulatory Roles Legal Regulatory Provide a broad risk assessment based on all relevant laws and factors known, i.e., specific product liability matters; investigations; engagements with customers, HCPs, medical societies, and 3rd party vendors, etc. • On-label promotion from perspective of FDA, OIG, DOJ and state enforcement actions • False advertising under Lanham Act, applicable state laws, and FTC • Product liability • Anti-Kickback laws and state consumer fraud • Other laws as necessary, i.e., privacy, intellectual property, antitrust, etc. Provide interpretation and precise application of all FDA regulations, guidance documents, and Office of Prescription Drug Promotion (OPDP, formerly DDMAC) enforcement actions •FDA requirements for labeling and advertising • FDCA, CFR and FDA Guidance • Not false or misleading • Supported by substantial evidence • Fairly balanced in presentation efficacy and Safety
- 8. 8 Collaboration with Marketing – Early and Often •Concept Reviews •Integration into the Brand Team, including Brand Planning
- 9. 9 Reviewers Not involved… BrandBrand PlanningPlanning BrandBrand PlanningPlanning ConceptConcept ExecutionExecution ConceptConcept ExecutionExecution PRCPRCPRCPRC Concept reviews traditionally take place here Review Team not members of the Core Brand Team RevisionsRevisionsRevisionsRevisions TacticalTactical ExecutionExecution TacticalTactical ExecutionExecution
- 10. 10 …Fuels the Waste BrandBrand PlanningPlanning BrandBrand PlanningPlanning ConceptConcept ExecutionExecution ConceptConcept ExecutionExecution PRCPRCPRCPRC Agencies hatch big ideas with few compliance parameters Non-starter’ ideas get explored and expanded RevisionsRevisionsRevisionsRevisions TacticalTactical ExecutionExecution TacticalTactical ExecutionExecution Agency develops noncompliant campaigns embraced by marketing as differentiating Overloads review resources with unnecessary reviews Agency rewrites materials at cost to the company Lengthy review process slows down marketing execution
- 11. 11 Collaboration with Medical •Medical Correctness/Accuracy versus Substantial Evidence •Review of study concepts to support claims •Review of HEOR studies to be used proactively under FDAMA
- 12. 12 Training •Regulatory Compliance Training • For Reviewers • For Initiators • For Agencies •Surveillance and Training on OPDP Letters
- 13. 13 More Quality, Less WasteQualifiedSMEsasReviewTeam CompliantIdeasfrom Marketing/Agencies Effective Process Pinpoint Knowledge Gaps + Qualify Thru Training + The Ideal
- 14. 14 Takeaways •Defined Process •Defined Roles & Responsibilities •Compliance Training •Highly Collaborative
Notas do Editor
- No Click: In most cases, regulatory is typically not part of the Core Brand Team which means we are not part of Brand Planning. Indeed, many companies consider the regulatory reviewer to be part of the Extended Brand Team (versus Core) which eliminates opportunities for very early discussion and regulatory input on proposed strategies and tactics. Since concept reviews traditionally take place during or right before the PRC, you can see why we are setting ourselves up for challenges.
- No Click: Here’s how agencies fuel waste in this currently broken system: First Click: The agency hatches a big idea with few regulatory compliance parameters; at this point, ideas that are essentially non-starters from a regulatory point of view get explored and expanded. Second Click: Now the agency begins to develop noncompliant campaigns that marketing embraces as differentiating Third Click: By the time PRC takes place, our reviews become unproductive because we are drained by having to review materials that are not compliant. Fourth Click: So the materials are kicked back which means the agency needs to rewrite the materials … at the cost to the company. Fifth Click: Ultimately, the review process is longer than necessary which means that marketing’s efforts are slowed down
- No Click: We can all agree that the ideal situation for our industry is to deliver higher quality promotional materials and reduce the wasted time and money associated with unproductive reviews. However, more quality and less waste is currently not the outcomes we see. First Click: That’s because regulatory, marketing and their promotional agencies are not aligned… Second Click: but we can bridge the gap. Third Click: I propose a 3-point plan to achieve this alignment: 1) change the current process Fourth Click: 2) pinpoint dangerous regulatory compliance knowledge gaps to enhance decision-making Fifth Click: 3) and qualify all staff involved in the promotional process through regulatory compliance testing. Let me take you through the specifics.