We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.
PAAB code 4.2.2 states: "The advertiser must honor market research company agreements and must submit a release of market share claims from the source of the data. Data should be the most current available, at least within the past six months". But all other provisions of the code applies. Please don't hesitate to call us if you have more specific follow-up questions.
If an advertisement exceeding the restrictions set out in Section C.01.044 of the Food and Drug Regulations is displayed on a Web site, and is accessible to individuals who are not healthcare professionals (HCPs), it would likely be considered in contravention of this regulatory provision. The type of login (e.g. through an institution's IP) would not be meaningful if it is allowing access to this material by non-HCPs. The key factor would be who may access or be exposed to the ad. It is therefore important for the market authorization holder to ensure that an adequate mechanism is in place to limit exposure to HCPs.
Although the PAAB code is not the basis of review for DTC (i.e. the review is based on Health Canada guidance documents), section 8 of the PAAB code relates to the administrative aspects of PAAB review and much of these are consistent between DTC and other submission types. The key exception relates to turnaround time. Our mandate is to provide a first response for DTC submissions within 4 business days (as opposed to 10 business days for HCP advertising & patient information). As with any PAAB submission, if you disagree with a PAAB correspondence received after having discussed that particular issue with the reviewer and responding to PAAB in writing with your position, you may set up a call involving the CRO, the reviewer, the manufacturer, and the communication agency. However, with regards to appeal to a panel as described in section 9.8, things are very different in the DTC realm. The nuance here is the difference between a PAAB ruling based on the PAAB code (i.e. HCP advertising and patient information) and a PAAB advisory opinion on DTC messages. The DTC advisory opinions are assessments as to whether materials, based on Health Canada's policy The Distinction between Advertising and Other Activities, are promotional, in which case they must be in accordance with the F&DAandRegulations, CDSA, and associated policy and guidance documents. PAAB will therefore consult directly with Heath Canada when there is disagreement on how to interpret these documents. For clarity and completeness, I should point out that PAAB provides advisory opinions on messages directed to consumers for prescription drugs (e.g., reminder ads), material discussing a medical condition or disease (e.g., help seeking messages, consumer brochures), Schedule D drug (biologics, including vaccines) advertisements, and other messages or materials (e.g., clinical trial recruitment announcements, press releases, institutional messages, etc.). PAAB has been providing objective review of DTC since the 1990. I refer you to the following link which outlines the roles of pre-clearance agencies and Health Canada: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php
Yes, if your piece is approved prior to your 'intended date of use', we can forward the start date of the acceptance period by a maximum of 3 months from the date of approval. Please advise PAAB of your intended date of use as part of your eFile submission or notify us during the active review process that this date has changed. Please find the link to our Submissions Guidance document and refer to the bottom of page 1 for additional information. http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Submission_Process.pdf
A pharmaceutical company has provided an unrestricted educational grant for the development of a disease-focused patient website. Can sales reps distribute postcards promoting the website (site name, disease focus, URL)?
From your question, it would appear that the piece is intended to be non-promotional. Assuming this to be the case, it is important to consider that distribution factors can render non-promotional content to be subject to the advertising regulations. As a general rule of thumb, if you want something to stay non-promotional, don`t add promotional elements (e.g. promotional cards, drug reps...etc). Having said this, drug reps may distribute a postcard promoting this type of website to HCPs, but this would render the website subject to PAAB review (i.e. we`d review the card and the website). Note that the card should be non-branded if the site is non-branded. Also note that drug reps should not distribute content directly to patients.
The core principle is that a claim should not rely on mice-type to save it from being misleading. The issue is potentially broader than the indication or dosage (hence the broadening in the new code). For example, just yesterday I saw the claim "Now covered as a general benefit" in an APS intended to be used across Canada. Nothing out of the ordinary here right? Well, the claim was cross-referenced to "Covered as a general benefit in Province X, covered with special authorization in Provinces A, B,C, and D". This has nothing to do with indication and dosing, but the principle in s3.1.6 should still apply.
Claims related to Class I, II, III, and IV medical devices as defined in the Medical Device Regulations (MDR) do not fall under the current scope of the PAAB. However, messages relating to drugs fall under the scope. The answer to your question therefore depends on whether the APS messaging relates to an entity which is classified as a drug or as a medical device. I note that your question relates specifically to DTC. Contrary to your question, PAAB assessments for consumer materials are based on the Health Canada guidance documents (not the PAAB code as suggested by "PAAB advertising rules").
I presume from your question that both your banner and your website are product branded. I also presume that the banners have run of site in the third party website (optimally with exception rules as described in Q&A 283). With this understanding, here are the answers to your two questions:
A) yes (provided the manufacturer has ensured that there is an appropriate mechanism which validates HCP status on the front end).
B) There is no outright prohibition against linking such banner to pages other than the homepage. But as some specific linkages may not be appropriate, we should be informed of where the banner links to during the review for our initial assessment of the APS. We should also be informed if the content on that link destination page changes in time. For banner ads containing claims, please refer to the guidance documents on our website for web destination requirements relating to prescribing information and fair balance.
I suspect there is a typo in your question. A branded patient piece may not discuss the broader product class or other product classes/therapies. Branded patient information is supposed to educated simply about the prescribed product and the medical condition. With that said, in either a proper branded or unbranded patient piece, a standard setting organization (e.g. the source described in your question) could be considered provided the content complies with the other code sections (e.g. s3.1).
I need a bit more info to provide an answer. Please clarify the following two parameters:
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
