Post hoc analysis is not accepted as evidentiary support for claims of benefit (PAAB s 3.1.1). The only exception which readily comes to mind is if the data is in the Health Canada approved Terms of Market Authorization.
Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.
The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?
Post hoc analysis is not accepted as evidentiary support for claims of benefit (PAAB s 3.1.1). The only exception which readily comes to mind is if the data is in the Health Canada approved Terms of Market Authorization.
Hi! Do corporate branded educational tools (no claims or messaging) need to be reviewed at paab? For example : knee bone joints? Or skeleton etc Thanks!!
A piece about a therapeutic area in which the manufacturer has a vested interest (e.g. knee/joints) would likely fall in the editorial APS realm (in which case, yes it should be submitted for review). See PAAB s7.5.
Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.
Lowest provided the criteria does not include a claim which triggers highest level (e.g. efficacy/safety claim) or middle (e.g. pharmacokinetic claim).
Dear PAAB Can the branding of disease specific information for medical professionals resemble the branding of a product not yet launched? (i.e. Does PAAB place any restrictions on the branding of disease specific information and product APS?)
This is a Food and Drug Regulations issue. You may want to get some background from your legal department. Promotion of a product (whether direct or indirect) which is not approved in Canada would contravene section C.08.002 of the Food and Drug Regulations. It therefore follows that Canadian materials (even if only comprised of disease information) should not utilize branding from other jurisdictions in which the sponsor’s product was approved. Keep in mind that healthcare professionals may have seen these branding elements online and/or at international conferences.
We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?
Drug rep activities do not fall under the scope of the PAAB. Whether the content can appear within advertising materials is a matter that falls under the scope of the PAAB code. We can assess whether the specific content from this study would be acceptable in advertising in the context of a formal PAAB opinion submission (see our fee schedule). The number of variables that require consideration causes this question not to be amendable to a general answer.
Is Pharma allowed to sponsor an independently-developed, physician-managed, online discussion forum? Pharma would have no involvement other than to provide funding for its development. What if the discussion forum is managed by Pharma's communication agency?
It’s not a matter of “can you?” It’s a matter of whether it is advertising? This assessment requires consideration of all 7 factors outlined in the Health Canada document “The Distinction Between Advertising and Other Activities”. PAAB can provide an opinion in consideration of all factors that are applicable in your particular case (see the fee schedule on our website).
If it is not advertising, it is not subject to the advertising provisions. If it is advertising, the answer is still “yes” but the pharma sponsor is responsible to ensure that the content falls within the federal advertising regulations.
The ASC's bulletin in April 2015 indicates that the statement "Product X is authorized for sale by Health Canada" is consistent with the Food and Drug Regulations and acceptable for use. Previous Ask PAAB questions #108 and #347 also address this issue and section C.01.007. We note that Health Canada's Consumer Advertising Guidelines for Marketed Health Products has precluded the use of statements that suggest authorization by Health Canada, and has not been updated since the ASC's bulletin. Can you please provide PAAB's position on the use of the statement above and also whether the use of "approved by Health Canada" or similar statements is acceptable?
At the 2015 Bilateral meeting. Health Canada confirmed that claims of “Authorized for sale by Health Canada” are acceptable. They instructed us to insist on this precise wording. E.g. do not use the term “approved”.
Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?
Class I, II, III, and IV medical devices are exempt from the provisions of the PAAB code (see sections 1 & 11 of the code). Claims in HCP advertising about drug delivery systems which are not classified as a medical device are subject to the PAAB code provisions (including the need for fair balance, evidence, clarity…etc.).
Refer to the Medical Devices Active Licence Listing (MDALL) on the Health Canada website for Class II, III, and IV devices. You could also refer to the Medical Device Regulations (MDR) on the Government of Canada Justice Laws Website for provisions relating to the classification system.
We are experienced in submitting DTCI campaigns through regulatory. In these cases, the focus is on the disease and when mentioning drugs, we discuss all treatments indicated for that disease (because there cannot be undue emphasis on any one drug). However, we wish to know about the DTCA of vaccines. For example, are we allowed to talk about the indication/side effects/dosing, etc for one vaccine specifically without mentioning the other vaccines indicated for the prevention of the same disease? In this case, it'll have the "undue emphasis" which is not permissible for schedule F drugs.
The provisions you mentioned for DTCI relate to ensuring that the material is not subject to advertising regulations. This is often a consideration because consumer advertising materials for products in the “prescription” schedule are restricted to name price and quantity. Vaccines are schedule D products. Manufacturers may promote the therapeutic use of their vaccines in consumer advertising. If doing so, it is important to include fair balance as per the following Health Canada Interim Guidance:
http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_dtca-pdac_vaccine-vaccins-eng.php
The PAAB reviews for Rx & Schedule D consumer materials are based on our interpretation of the Food and Drugs Regulations and the Health Canada policy document “The distinction between advertising and other activities”. See the fee schedule on our website for details.
As a follow-up to Question #299, we would like to ask if it is acceptable to still post such a video on YouTube but make it an unlisted video.... only found when pharmacist's share the URL with a patient who need to learn how to use the product . Thank you for your help !
Let’s step back from YouTube specifically for a moment. For a URL to essentially be used as the password confirming that someone is a patient, BOTH of the following conditions need to be met:
If you are not confident about either (or both) of these, there is a good chance that Food & Drug Regulations C.01.044 will be contravened (perhaps inadvertently).
What’s important here is the outcome (i.e. that the two conditions listed above are met), NOT the process (i.e. “I selected the unlisted broadcast option”). This is because “unlisted” means different things on different social platforms. Additionally, even within a given platform, you can often modulate aspects like ability for users to share the video with broader circles of contacts or even the ability to embed the video on any website and/or blog thus opening the video to the world.
Okay, back to YouTube. For everyone’s benefit, at the time of responding to this question there are three different broadcast options for YouTube:
You Tube is designed to make the sharing of videos between users and the embedding of videos into open websites/blogs extremely easy. I do not know whether there is currently a reliable way to ensure that both above requirements are met except in the context of the “Private” broadcasting option (which may not be practical due to the imposed maximum on the number of invites). Let me know if there are ways to meet the above requirements and I’ll update this answer accordingly. Some caution is warranted as there have been instances of “unlisted” videos going viral.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de