539
When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).
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Voir réponse [+]
Often digital tools contain elements which are not available in print format. For example, linkages to other APS, the ability to swipe/tap/scroll, and other functional elements. If the digital format contains any additional functions beyond the print version then the piece would require separate PAAB review.
If the same content/layout /flow is maintained in the digital and print version, and the APS context (e.g. branded vs. unbranded) and target audience remain unchanged, then the two pieces may be considered as part of a single submission. For example:
- any size changes must be directly proportional throughout the APS.
- content on the page are not repositioned to optimize for landscape/portrait mode.
- no new functionality is added other than zoom-in and zoom-out. ( i.e. PDF version of the printed piece is presented on a tablet).
538
What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?
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Voir réponse [+]
The PAAB considers the TMA in it’s totality when ultimately determining what is and is not acceptable in advertising. It’s therefore impossible to predict the best approach for your situation given the limited information we have. We will however do our best to provide information which steers you in the right direction.
The indication statement describes the Health Canada approved use for the drug and sets the boundaries for patient selection. If the indication limits use of the product to “monotherapy” then all information in advertising would be restricted likewise. Any discussion of combination use would be considered off-label advertising. While inclusion of “monotherapy” in the dosing section may not appear to have the same degree of limitations, it is important to remember that APS are still required to be consistent with and within the limitations of the product monograph. Promotion of combined use would still be questioned without the appropriate supporting copy from the TMA (i.e. studied in combination in clinical trials, dosing section, etc.).
There are many PM factors which could impact the answer to your question. For example, if the indication states that the product is generally to be combined with other therapies, and the dosing section of the PM provides a specific scenario in which monotherapy may be considered, content relating to use in combination therapy would be required to be presented as the primary message. This content could be followed by content completely & accurately capturing the PM scenario in which the product may be considered as monotherapy. As there are many different possible PM scenarios, we invite you to submit your scenario through the PAAB’s opinion review service (see the fee schedule on the PAAB website).
537
Can a sales rep use a slide deck that discusses the study design, inclusion/exclusion criteria, and patient characteristics for study in an indication for which they don't yet have approval?
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Voir réponse [+]
In this scenario it is important to differentiate between completed studies and ongoing studies.
If the off-label study is no longer in the data gathering stage (i.e. it is completed), then the study cannot be discussed in an APS until the TMA is adjusted accordingly.
A study which discusses outcomes outside of the Terms of Market Authorization can be discussed if it is on-going. The discussion should be limited as per PAAB code section 3.2.3:
"Reference to research or ongoing studies may be made in a nonpromotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada Terms of Market Authorization, should not be mentioned in advertising". PAAB defines “ongoing” studies as studies which are still within the data gathering stage. Once data gathering is complete and/or an interim analysis is conducted, the study no longer meets the definition criteria for an “ongoing” study, even if the data has not been published, made public, or a follow-up/extension study is underway.
Note: If the product does not have any indications in Canada, then even the use of ongoing studies in advertising would not be acceptable.
536
Hello. I work in the advertising industry, and have been discussing with a prospective client a direct mail piece in support of a prescription product. I understand that you cannot communicate the product name and specify what what malady it treats, but it must be a generic message advising to speak to their healthcare practitioner. My question is that if I were able to source a list of individuals who have reported having this condition, could I send this generic unbranded awareness piece to that identified person?
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Voir réponse [+]
It is important to differentiate between the audience and content of the message. Product branded pieces (content) to a consumer (audience) must not go beyond name price quantity for prescription products. If product branded advertising was targeted specifically to consumers with a particular condition, this would appear to contravene section C.01.044 of the Food and Drug Regulations (i.e. targeting patients who have a condition with advertising for a product related to that condition creates a link between product and therapeutic use). This is true EVEN if we assume that the advertising message itself was limited to name, price, and quantity.
A consumer brochure or help seeking announcement meeting the provisions stated in the Health Canada policy document “The Distinction Between Advertising and Other Activities” can be targeted to a list of individuals who have reported having a condition. This is acceptable by virtue of the fact that consumer brochures and help-seeking announcements are not product advertising if they meet the provisions in the aforementioned Health Canada document. PAAB provides an advisory opinion on the acceptability of these pieces/campaigns based on the Health Canada “The Distinction between Advertising and Other Activities” document. See the fee schedule on our website.
535
The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?
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Voir réponse [+]
Patient information that will be distributed by or recommended by a health care professional falls under the PAAB scope of review. The question then becomes whether it is exempt from review. As in Ask PAAB #321, a patient piece generated by the manufacturer or its agent requires PAAB review unless both of the following conditions are met:
- there is no discussion of drug therapy (by product, class, or category)
- there is no discussion of drug issues (e.g. adherence to medication, potential implications of product ingredients…etc.)
The card discusses the issue of interactions in the context of the drug therapy and therefore requires PAAB review.
534
Hello! We, working on behalf of a European based pharma-company, are planning to sponsor an industry symposium at a 'World Congress' being held in Canada, in 2017. The content of the symposium will be generated by external speakers/expert clinicians. There may be some information/published data presented, relating to the sponsor's and other licensed pharmaceutical products, within the speakers' lectures, related to the wider context of the 'management and treatment' of the condition/s. Do the slides and any other related scientific content, for a symposium within a 'World Congress' setting, need to be submitted for review and approval by PAAB? The sponsoring company's products are licensed in Canada. Thank you, in advance, for your guidance; we appreciate your support.
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Voir réponse [+]
Hello. The criteria for International Conference materials not to be subject to Canadian advertising regulations are as follows (taken from the Health Canada policy document “The Distinction Between Advertising and Other Activities”):
- the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions,
- the material must emanate from the parent company of the manufacturer,
- the material must only be for use within the confines of the conference, and
- the material is prominently identified as not being authorized for sale in Canada.
The slides for the symposium would be subject to Canadian advertising regulations (including the PAAB code) unless all those criteria are met.
There are a lot of moving parts which determine whether a symposium at an international conference would require PAAB review so it is difficult to respond to a general question on this matter. However, I can provide some examples of considerations that would impact whether the symposium is likely exempt from Canadian advertising regulations. This is not an exhaustive list.
For example, the symposium would likely be subject to the Canadian advertising regulations if the external speakers/expert clinicians are selected (and/or funded) by the Canadian subsidiary rather than the European parent company (as the event would not be emanating from the parent company – criteria ii).
As a second example, the symposium would be subject to the Canadian advertising if it where promoted to Canadians either by the parent Company or the Canadian subsidiary (as the corresponding promotion for this symposium would not be within the confines of the conference – criteria iii).
If all four criteria listed above are indeed met, then the materials/event would not be subject to Canadian regulatory provisions for advertising (including the PAAB code). I suggest prominently disclaiming that the information comes from the European labelling/Marketing Authorization AND that this information is not consistent with the Canadian labelling/Market Authorization.
533
For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required.
532
We have a PAAB-approved print piece that we would like to use in a digital environment. None of the content of the print piece will change, but the layout will be different. Would it suffice to submit the new layout with the approved print-piece e-file number or will you need to re-review the content (i.e., need a copy deck)?
531
Re: Q#522 for use of Summary Basis Decision in advertising and you replied: "Yes. Provided the content referenced from it is not inconsistent with the product monograph", if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight as the PM, then it should be acceptable. Is this an accurate assessment?
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Voir réponse [+]
It’s not a matter of “same weight” per se. It’s simply a matter of appearance in the SBD being evidence of approval by Health Canada. In response to your question, yes the SBD data would generally be accepted (in a similar context). However, if the presentation were to appear to contradict something in the monograph, we would first consult with Health Canada for clarification of the disparity.
530
What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?
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Voir réponse [+]
You can't promote the excursions in advertising until you update the Product Monograph.
