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I would appreciation clarification of Section 6.6 of the code related to patient information direct from and consistent with the Product Monograph in combination with gating requirements. If a video is created that walks a patient through how to administer the injection as per part III, does not mention what the product is used for, and that video is posted (with no gating) on the company's website right below the product monograph for that product (as you know companies typically have a page on their company site with all their product monographs posted)......is 1) that video exempt from PAAB review and 2) Can the video be left ungated in this situation (i.e. Does proximity to the monograph pose an issue)? Thank you.
This question deals more with consumer advertising regulation (rather than section 6.6 per se). We had posed the question to Health Canada some time ago but have yet to receive a response. We will update this answer upon receipt of the Health Canada response.
Hi, would a product announcement with: the name of the product, "now available in Canada", and package shot (with no visible therapeutic claims) be considered paab exempt? if the product came in multiple pill sizes, can a shot of the pills with their sizes be allowable as the product shot?
Not sure I understand so I’ll reframe it. An APS with ONLY the drug name + the pack shot (with no visible claims at all) + the claim “now available in Canada” + a shot of the actual pills (actual size) is exempt.
If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products?
Yes. As long as you can be clear which statements/risks apply to which products.
On a STI sample card the Brand name is included along with images of the product. Does this need to be PAAB approved or is it exempt (i.e. no claims are included, no indication statement just product name). Thanks
The card itself can be exempt (even though it contains the Brand name) if it contains only transactional information for the pharmacist e.g. insurer, carrier code, and other computer entry instructions related to billing. If there is additional information such as mention (or linkage to) disease/condition OR corporate messages review is required. Recall PAAB reviews corporate messages with product mention under s7.4.
Since DTC advertising is not allowed for products that treat or prevent schedule A diseases, I was wondering whether a product that managers a symptom of a schedule A disease (example: hypoglycemic reactions in diabetes) would have the same restriction?
Yes. See section 2.3.2 here:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/scha_guide_ld-eng.php
“Many Schedule A diseases are closely associated with symptoms or signs, such that reference to them implies the disease itself. A claim to treat, prevent, or cure a description of a Schedule A disease (that is [i.e.], signs or symptoms) is considered to be a claim to treat, cure, or prevent the disease itself”.
We will be running a webinar from our HCP website. The webinar will be delivered by an internal medical expert. The webinar content will be on-label and pre-cleared. HCPs will need to register for the webinar on the "events" section of our gated HCP website. This section would only contain a list of upcoming webinar events. The description for the webinar would include; title, date, time location and a basic bio of the speaker. If the webinar title does not include mention of any specific products and the remaining info is purely factual details about the event date, time & speaker credentials, does this content need to be pre-cleared by PAAB?
I presume the event section is gated by some sort of system that requires validation that the user is an HCP. Give me a call at the PAAB office so we can discuss the possibility of setting this up as a general template which PAAB can review a single time (but which you can use across the life of this initiative with renewals). The reviewer of the webinar should be made aware that this page links to the webinar he/she is reviewing (as PAAB should be made aware of all inbound and outbound links).
Upon preliminary glance of the info in your question, the main sticky point appears to be inclusion of the event title. But there may be a way to standardize that e.g. “Webinar on the management of X” where X is the name of the medical condition and this matches the title of the PAAB approved webinar. I am assuming the webinar itself is an editorial APS rather than the product branded APS. We’ll discuss this further when you call me.
Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it matter if a dose card was not included? To summarize, does a demo kit fit Code Section 6.6 (iv) .....use of a drug name only in a context not linked to therapeutic or promotional messages. Or is it considered a Service-Oriented Vehicle under Code section 6.4, even if it's a demo kit?
At the time of initial PAAB review for the brochure, we should be informed of all items that will be distributed along with the piece. It’s not just about the explicit messaging but also how the item may take on a meaning in the context of the brochure or how the item may inherently add meaning to the brochure.
In both examples above, the linkage of the ancillary items to the PAAB approved piece contravenes the code (even though the items themselves do not contain a single word). In short, if we are approving a piece, we need to know what context it will be used in (and this includes knowing what items will appear with it). In cases where the other items do not carry text and would be otherwise exempt as separate items, they can be reviewed as part of the submission for the brochure or box kit (rather than separate dockets).
Removed 07/2018
Where can I get the detail guidance around layouts (ie, font size, specific/mandatory placement of info etc)? Thanks.
Assuming you mean guidance about fair balance size, placement… Here is the link you are looking for.
http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Base_Fair_Balance_Level_Selection_and_Placement.pdf
What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)
It’s difficult to predict all the info needed to guide you in the right direction as I don’t know exactly what you have in mind; however, here are the themes that jump to mind as likely being relevant to your case. Ultimately the evidence requirements are dependent on the types of messages which need to be supported. “Appropriate courses of therapy” (e.g. what should we do now?) should reflect authoritative Canadian consensus guidelines (per s3.2) rather than relying on faculty opinion/recommendations. The courses of therapy should also be consistent with the relevant product monographs (s3.1). It sounds like you’ll need to be careful to avoid creating a piece which disparages the sponsor’s competitors (s5.6.iv). Finally, as the piece is intended to be “unbranded” you’ll want to make sure you adhere to the principles in s7.5 for editorial advertising. For example, make sure the piece NEITHER emphasizes the sponsor’s product over the others NOR favours it over the others. You might want to consider submitting an opinion file with a detailed description of the concept prior to testing (see the fee schedule on the website).
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
