Non-product branded APS, pre-NOC teasers
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715 - Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca
• Jennifer Carroll -
628 - Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?
• Jennifer Carroll -
578 - Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general information regarding disease state. Do we need PAAB approval or ASC approval alone is sufficient?
• Jennifer Carroll -
556 - Can we provide marketing items such as pencils, cups or post-it with braded name only of future prescription drug currently under NOC review (not approved yet in Canada) but FDA approved. Distribution would be to general Canadian public and health care practionners during Canadian conventions.
• Jennifer Carroll -
549 - A company is entering into a new disease state in which they don't already market a product in Canada.If they produce a corporate ad (pre NOC) indicating that they are now entering into the therapeutic area/disease state, can they mention the therapeutic area/disease state in the ad?
• Jennifer Carroll -
473 - Dear Patrick, I have a question regarding references that can be used in unbranded pieces in the category of cold and flu. As you know, the active ingredients in many cough, cold & flu products have long since become generic and in fact are used across a number of different products... I was wondering if experimental studies (e.g., in vitro/cell culture/ELISA), which do not use any brand specific sources of the molecule (i.e., generic), could be used in unbranded pieces to educate HCPs on the properties of the molecule (with any necessary caveats that clinical significance cannot be determined)? Thanks!
• Jennifer Carroll -
311 - If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?
• Jennifer Carroll -
238 - Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?
• Jennifer Carroll -
235 - Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?
• Jennifer Carroll -
40 - At a recent medical conference there was a company display that promoted a disease specific message. There was no product mention and the posters did not go to PAAB, although the imformation clearly introduces a specific message. As per question and answer #39, this would seem to be within guidelines, assuming there was no other promotional material at the booth. The complicating factor is that this company does not have an approved product for the disease state being presented. There is a great deal of discussion and "noise" surrounding their product and when it will be available but, to date, it has not receieved NoC. Is this within guidelines? It appears to be promotion for a product currently undergoing review?
• Jennifer Carroll