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385 - Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.
• Jennifer Carroll -
384 - What type of references are allowed in unbranded materials? I am interested in using studies which are based on patient surveys/questionnaires as well as some review papers (neither of which have a focus on the company's branded product). Would these type of references be allowed or are strictly limited to the same rules as branded communications? Thanks.
• Jennifer Carroll -
383 - We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page containing product claims? 2) Can treatment guidelines be included on the other side of a page containing the main sections of the Product Monograph of product sited in the guidelines (Dosage, Indications, Warnings and Precautions, Contraindications and Adverse reactions)?
• Jennifer Carroll -
364 - Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?
• Jennifer Carroll -
292 - Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!
• Jennifer Carroll -
285 - Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!
• Jennifer Carroll -
284 - Hi Patrick! We're looking to collect data from a patient survey related to dosage and administration. Ultimately, we would like to disseminate this information to HCPs so they are more aware of their patient behaviour and preferences in relation to their treatment. Could you suggest a way we would be able to do this? Thanks
• Jennifer Carroll -
278 - In an APS for a prescription product, if you want to present side-by-side comparisons of non-therapeutic information from Product Monographs (e.g., product properties, use limitations) as per section 5.10.2, do you need to include all of the approved products in that indication or is it acceptable to show only selected products (e.g., two out of five available agents)? If all products must be mentioned, does that also include generics or only branded products? Thanks!
• Jennifer Carroll -
273 - Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we don't make mention of them in the APS?
• Jennifer Carroll