@ PMCQ U October 19, 2004

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

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

“ 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 ”

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

What is pre-NOC product advertising ?

illegal

Off-Label Use vs Off-Label Claim

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

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

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

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

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

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

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

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

Don’t Abuse a good policy

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

Pharma Co Advice l marketing work with regulatory to ensure PM content is relevant for promotion l 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

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

Thank You