-
432 - With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions "treatment" without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait.
• Jennifer Carroll -
410 - If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination. The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product. The company does not have any ability to alter content if there is a comment from PAAB. We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way). We are running into similar issues...
• Jennifer Carroll -
389 - I would appreciate clarification of the Explanatory Note for 6.6 that says "Now on provincial formulary" (or equivalent). Does "or equivalent" allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the formulary and it is that new strength of Product X that is being announced as "Now on Provincial Formulary". Thank you!
• Jennifer Carroll -
382 - I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only "on-label" information, and further provided the Rep does not include any summary of the article, but does discuss the approved benefits of Product X during the call, would not be considered advertising?
• Jennifer Carroll -
376 - We have a PAAB-approved fax blast for pharmacists. Our marketing team wants to remove the product codes and prices and send the piece to physicians. This is the only change…would the revised fax blast need to go through PAAB-review? If it does not, is it ok to keep the PAAB logo on the piece?
• Jennifer Carroll -
369 - Hi Patrick. Accreditation for a CHE program has expired and the company wants to turn it into an OLA. The role of the reps is restricted to logistics only and the content is all on label. The program has been developed by HCPs and is presented by trained HCP speakers. Does the OLA content need to be reviewed by PAAB? Thank you.
• Jennifer Carroll -
363 - Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA
• Jennifer Carroll -
360 - A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter. QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?
• Jennifer Carroll -
343 - We are planning market research with healthcare professionals to identify new marketing insights and opportunities. The research will be in the form of informal interviews/discussions with HCPs. Does the PAAB need to be involved with the research planning? This would be organized and conducted by an agency and the sponsoring client would only receive anonymous insights and findings. Does the answer depend on any of the following? If interview questions are provided to the HCP in advance vs. an impromptu discussion? If the interview/discussion covers specific products vs. only diseases.
• Jennifer Carroll