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@ PMCQ U October 19, 2004

@ PMCQ U October 19, 2004. What is Advertising? Pre-Launch Activities You Can Do PAAB pre-NOC Meeting/Review policy. Agenda. Advertising and Labeling. Health Canada terms of market authorization - Notice of Compliance (NOC) approved conditions of use in product monograph (part of NOC)

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@ PMCQ U October 19, 2004

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  1. @ PMCQ U October 19, 2004

  2. What is Advertising? Pre-Launch Activities You Can Do PAAB pre-NOC Meeting/Review policy Agenda

  3. Advertising and Labeling • Health Canada terms of market authorization - Notice of Compliance (NOC) • approved conditions of use in product monograph (part of NOC) • advertising claims must be consistent with & within limitations of product monograph and labeling accepted by Health Canada

  4. “ Advertising ” Health Canada Definition “ any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device ”

  5. Health Canada Policy See “Distinction Between Advertising and Other Activities” on the Health Canada web-site

  6. What is pre-NOC product advertising ?

  7. illegal

  8. Off-Label Use vs Off-Label Claim

  9. Off-label use • New, different or broader indication • New or broader patient population • Modification of usage rep distribution of reprints or setting up meetings with MD speaker to promote pre-NOC or off label is not acceptable

  10. Off-label claim • may or may not be acceptable • comparative claims within approved indications for both products • claims more detailed than the approved labeling • claims of efficacy in patient subgroups with some exceptions

  11. Pre-Launch Activities • Consultant/Advisory Groups • Market Research • CME • Institutional Advertising (s7.7) • Editorial Advertising (7.8)

  12. Consultant/Advisory • experts • contract • limited number • long term (years) • see Rx&D Code

  13. Market Research • legitimate fact finding to help marketing planning • non-promotional • not done by sales representatives

  14. CME • accredited CME • independent of pharma company (see new ACCME guideline) • academic institution control • no pharma company control • this does not mean meetings set up by pharma company or their agents.

  15. Advertising Institutional (s7.7) • talk about research , ongoing trials • NO - “coming soon”, product messages, product logos, graphics, icons Editorial (s7.8) • talk about therapeutic area, other drugs with approved claims, mechanism of action • NO product mention, safety or efficacy claims

  16. PAAB Pre-NOC Policy • final draft of the Product monograph • not the usual queue • two core A/PS reviewed by medical • preliminary review with revisions • when NOC received send all materials together - reviewed sooner • lost time on foreign advertising

  17. Don’t Abuse a good policy

  18. Pre-NOC Meetings • disease overview • market overview • PM highlights • pivotal clinical studies • be open and complete • call John Wong for setup

  19. Pharma Co Advice • marketing work with regulatory to ensure PM content is relevant for promotion • material for PAAB review should be: • approved by medical • cornerstone of claim structure • allow for awareness raising ad • providing support for detail pieces • post NOC APS should be complete and consistent with pre-NOC APS

  20. Can we trust the pharmaceutical industry to act in a responsible manner?

  21. Thank You

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