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Developing an Effective Ad-Promo Review Process


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I presented this deck to the AdvaMed Advertising and Promotion of Medical Devices Conference on November 7, 2018.

Published in: Healthcare
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Developing an Effective Ad-Promo Review Process

  1. 1. Developing an Effective 
 Review Process for 
 Medical Device Promotion Presented by: Dale Cooke
 PhillyCooke Consulting
 @PhillyCooke November 7, 2018
  2. 2. PhillyCooke Consulting helps companies communicate about FDA-regulated products using 21st century tools, while remaining compliant with regulations written in the 1960s. PhillyCooke Consulting services focus on 1. Review & Approval Process Improvement 2. Training 3. Promotional Review of Tactics 4. Policy Development 5. Agency Submission Preparation
  3. 3. Disclosure: PhillyCooke Consulting is not a law firm, and nothing provided in this presentation should be construed as offering legal advice. Specific details of each company’s promotional efforts might require adjustments of the information provided in this presentation. Use of examples does not constitute
 endorsement of the practices shown.
  4. 4. Topics 1.Why Review Ad-Promo 2.Review & Approval Process 3.Review Systems 4.Best Practices !4
  5. 5. Why Review Ad-Promo?
  6. 6. Risk Mitigation Promotional materials are public documents viewed by multiple audiences, including: ‣ Competitors ‣ Plaintiff’s attorneys ‣ Department of Justice ‣ FDA ‣ Whistleblowers !6
  7. 7. Risks from Promo Materials ‣ New intended uses/off-label promotion ‣ False claims act prosecutions ‣ Antikickback statute violations ‣ Product liability ‣ Claims substantiation Plus traditional legal concerns ‣ Trademark ‣ Copyright ‣ FTC compliance ‣ Sweepstakes & contests !7
  8. 8. Unique Challenges to the Medical Device Industry ‣ No 2253 filing (don’t get the final samples) ‣ No expiry review (outdated materials still being distributed) ‣ No tracking material release/expiry (literally no idea what is being used) ‣ Homemade materials (especially from contractors) !8
  9. 9. 510(k) Modification Guidance !9
  10. 10. Especially challenging materials ‣ Digital tactics ‣ Social media/engagement !10
  11. 11. Review & Approval Process
  12. 12. Although there are laws about the communications themselves, there are no laws or regulations about how companies comply 
 with the regulations. !12
  13. 13. Functions Don’t Vary 1. Concept Review 2. Med-Legal Review 3. Check Changes 4. Executive Committee Review 5. Final Samples !13
  14. 14. Functions Don’t Vary 1. Concept Review 2. Med-Legal Review 3. Check Changes 4. Executive Committee Review 5. Final Samples !14
  15. 15. The Final Step The 2253 submission is itself a regulatory requirement for all product promotions ‣ No product promotions
 can be used prior to
 submission on Form 2253 This does NOT apply to
 medical devices or 
 disease awareness 
 communications !15
  16. 16. It’s Finally Approved… Until It’s Not The quarantine/annual review All materials have a sunset provision for their use Typically, that’s one year; sometimes two years. Six months if using the word “new.” !16
  17. 17. Systems
  18. 18. The Enemy !18
  19. 19. Review Systems Are Great Benefits include ‣ Faster approval times ‣ Complete audit trail ‣ Lower agency costs ‣ Improved compliance Drawbacks are real: ‣ Systems don’t fix process flaws ‣ Expensive ‣ Infrequent users are confused !19
  20. 20. Essential Features ‣ Unique item number from promotional pieces ‣ Clear status indication (approved for use, unapproved) ‣ Expiration date !20
  21. 21. Best Practices
  22. 22. Determining Membership and Ownership ‣ Legal ‣ Medical ‣ Regulatory ‣ Engineering ‣ Compliance !22
  23. 23. Clearly Communicate Outcomes There are only four possible outcomes of a review ‣ Approved ‣ Approved with Changes ‣ Revise & Re-submit ‣ Rejected !23
  24. 24. Expedited Reviews ‣ Emergencies justifying expedited review will happen ‣ SOPs should accommodate the need for such review ‣ Ideal procedure strikes a balance, neither too easy nor too difficult • For example, requiring signatures of Business Unit VP for expedited reviews is something that can be done, but is not likely to be abused because people don’t want to repeatedly ask for the exception ‣ Track the number of expedited reviews !24
  25. 25. Submissions Deadlines ‣ There should be a deadline for submitting materials for review at an MLR meeting ‣ Reviewers should have time to review prior to meetings ‣ Tuesday & Wednesday at noon are the magic times to get the best work from agencies ‣ Re-reviews & check changes reviews should require less advance submission time !25
  26. 26. Approval to Use Message ‣ Clear definitive communication should occur that materials may be used ‣ Electronic systems will auto-generate such a message !26
  27. 27. Measuring Performance ‣ Develop metrics that affect performance, not that are easy to measure ‣ Evaluate performance of all parties (ad agencies, brand managers, reviewers, marketing ops) ‣ Distribute the evaluations regularly (monthly or quarterly) • Make ad agency performance public to all brand managers and agencies • Make brand manager, reviewer, and marketing ops performance visible internally !27
  28. 28. Sample Metric Ad agency performance on MLR reviews ̶ Are materials submitted on time? ̶ Do materials contain spelling, grammar mistakes? ̶ Was the medical referencing acceptable? ̶ Were all components included as required? ̶ Were any paperwork/submissions forms completed correctly? !28
  29. 29. Additional Process Points ‣ Add a formal chair to all meetings ‣ Conduct paperless reviews ‣ Providing a formal mark-up of changes requested from every review ‣ Have a separate editor, reporting to Regulatory Department ‣ Shift responsibility for the check changes to the editor from the brand manager or reviewers ‣ Multiple review streams for types of projects (re-sizes vs. new content) !29
  30. 30. Annual Reviews ‣ Few websites (or many other digital tactics) will remain unchanged for a full year. ‣ Frequent updates to portions of these tactics can result in full tactics failing to undergo typical expiration/annual review ‣ To address this: 1. Establish an annual review date on first submission of the tactic 2. Permit updates up to 90 days prior to the expiration date 3. Any update within 90 days of the expiration becomes the annual review !30
  31. 31. 2253 Filings ‣ Decisions about what to file and how have regulatory implications ‣ Many enforcement actions include 2253 submissions failures ‣ Companywide policies are needed and must be updated annually • Submissions come from your company ‣ Recent FDA guidance provides good starting point Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format— Promotional Labeling and Advertising Materials for Human Prescription Drugs FDA 2015 !31
  32. 32. Executive Committee Role ‣ Frequently Executive Committees are used solely to resolve disputes ‣ Can play a vital role in endorsing (or correcting) decisions about new technology & disseminating those decisions throughout the company !32
  33. 33. Questions? Dale Cooke PhillyCooke Consulting @PhillyCooke on Twitter !33
  34. 34. Dale Cooke Dale Cooke is the president of PhillyCooke Consulting, which helps companies communicate about FDA-regulated products using 21st century tools, while remaining compliant with regulations written in the 1960s. Dale has worked with more than 50 pharmaceutical and medical device clients and more than 20 advertising agencies around the world. His insights have been featured in the Politico, The Pink Sheet, Stat News, Law360, and other publications. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), the Alliance for a Stronger FDA, and the Google Health Advisory Board. Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is now in its second edition in FDLI’s Topics in Food and Drug Law 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 life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall University’s School of Law. Dale is currently enrolled at Drexel University’s Kline School of Law with anticipated JD completion in 2019. !34