Linkage Issues
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720 - What are the rules regarding using similar graphic symbols for branded PAAB approved promotional pieces addressed to HCPs and branded DTC materials for the same OTC product. Is it acceptable that they have the same graphic elements such as icons to illustrate the approved claims/indications?
• Jennifer Carroll -
716 - Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.
• Jennifer Carroll -
691 - With regards to the PAAB-exempt regulations, and the requirement to not link to product information - can you confirm if the definition of linkage is in the language used in the piece? For example, if you had a webinar invitation that had only the product name (no indication, disease information, etc) however that invitation was inviting someone (via website link) to a webinar/registration page etc that was all PAAB reviewed/approved, is the invitation still PAAB exempt or by virtue of having a weblink (or intention to direct to PAAB-approved material if it were paper copies etc), is the invitation now in scope of PAAB review?
• Jennifer Carroll -
654 - Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.
• Jennifer Carroll -
577 - Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.
• Jennifer Carroll -
574 - I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website to PAAB review?
• Jennifer Carroll -
558 - If we are developing a postcard with a link to a patient education website on it (website will go through ASC approval) that is designed for the sales rep to give to an HCP to give to their patients, will PAAB have to review the entire website who's link is on the card? The website will have nothing brand specific, it will display all treatment options for patients, however it will have the company logo on it. Thanks!
• Jennifer Carroll -
480 - Is it possible to link a site with CME content from a gated, branded website? If so, is it possible to identify the tab as leading to CME content? Would it be possible to link to a CME-containing site using an interstitial page/disclaimer between this site and a branded website?
• Jennifer Carroll -
402 - Hi, I am looking for a ruling on the following scenario. If a sales rep is using a PAAB approved, Un-branded, Disease state promotional piece to engage an HCP in a non-product related discussion. If, during that discussion, the physician asks that representative a product specific question, i.e. "What is the clinical data for Product "X" in the disease state we are discussing?”. Is the rep allowed to answer the question and switch to a product based discussion that incorporates PAAB approved promotional pieces? What specifically can the rep do in a situation like this where the use of PAAB approved messaging and promotional pieces are strictly reactive?
• Jennifer Carroll -
359 - Referring to PAAB Code 6.5.4 - The sponsor may link to corporate global sites only by linking to the global site home page. The sponsor should not link to the global site product pages or sections. Please confirm if we can link to the homepage of our Corporate website for Canada (.ca) or do we have to link to the global site (.com)? Lastly, our source for product monographs is our local corporate website. Please confirm that we can link directly to our product monograph from our promotional websites for quality control.
• Jennifer Carroll -
356 - Could you please clarify the response to Question 232, as it seems to imply that there is no such thing as a true "unbranded" piece. The nature of the Rep-HCP interaction is such that unbranded and branded discussions frequently take place in the same call. It was our understanding that as long as there is a clear transition/distinguishing between unbranded and branded content, that pieces are reviewed separately without assuming linkage.
• Jennifer Carroll