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If a company is a member of IMC, do they have to submit their promotional tools to PAAB?
The PAAB Code is a voluntary code that applies to all companies who advertise healthcare products within the scope defined in the PAAB code. Health Canada encourages those companies to use the PAAB preclearance mechanism. Please consult IMC regarding advertising issues relevant to their code of conduct and membership requirements.
HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording "Now Approved In Canada". Also, if this is marketed to general population, does it need PAAB approval? Thanks
In response to your question regarding PAAB preclearance, consumer advertising does not require PAAB review. However, PAAB does provide an advisory opinion for consumer advertising which is recognized by Health Canada. We offer this review for prescription drugs, vaccines, and ethical drugs. As stated in Q&A 347, Health Canada has asked preclearance bodies to question claims of “now approved” per section C.01.007 of the Food and Drug Regulations.
As clarified in Q&A 501, Health Canada has stated that it considers the statement “Product X is authorized for sale by Health Canada” to be acceptable in advertising as long as it is not presented in a context implying endorsement or recommendation by Health Canada and no reference is made to the legislation or approval process. The link to the minutes for that meeting can be found on the PAAB website: http://paab.ca/2015_RoD_final.pdf
Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per PAAB's guidelines, is there a minimum number of respondents needed in a survey to be able to use the statistics produced by it in promotional tools. Thank you
The PAAB requires the methodology to be valid, and part of this (only one part of this) is the number of respondents. There is no single set criteria around the number of participants needed. Ultimately, what is considered reasonable with regards to the survey size depends on several factors including but not limited to the research question and the condition. For example, we can appreciate that some conditions don’t have 1000 patients in North America. Please see Ask PAAB question 551 for more relevant information.
Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks!
As per PAAB code section 4.4.4, the reference citation format should be clear and complete. The PAAB does not dictate the specific format in which references are provided.
I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is US-developed (independent of Canadian input) and presented to a US-Healthcare professionals audience only, is the material developed subject to PAAB review? A few mitigation steps would be in place: • All learning event promotional tools (such as the invitation) will state that Canadian physicians and any Canadian healthcare professionals (HCPs) will not have access to this event. • A check-in safeguard system will be set up at the entry of the event (such as checking and scanning the badges) to ensure access is only granted to US-HCPs. • A disclaimer will be included at the bottom of each slide of the presentation clearly stating that all information is based on the US prescribing information • The local internal review team will review and attest to the presence of this disclaimer before the slide deck can be used at the event. Thank you in advance.
If Canadian HCPs will not have access to the event and auxiliary materials, this would be out of the scope of the PAAB code. PAAB Preclearance is not required. We assume from the question that Canadian HCPs would not be targeted with invitations.
Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks
It’s the same standard as for all your HCP assets. Yes, HCP license works. I’ll warn you that some clients have reported that an HCP number pattern does not work. Inevitably, once they’ve considered all HCP types, just about any combination of numbers will gain entry. Since hearing about this, I’ve recommended against that. You could also have entry into the site managed by a third party that validates the person to be an HCP. Note that the HCP should not be granted temporary access to the site while verification is occurring.
If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.
If the article falls in the scope of the PAAB code, the manufacturer must be identified for transparency (PAAB s7.5). If it is not in the scope of the PAAB code, then it does not fall in PAAB’s jurisdiction.
Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?
No. The data from the later analysis can only be included in the piece once it is included in the TMA.
Can you please explain why a claim of "Guidelines recommend..." can only contain the generic drug name, vs. brand name? Would it make a difference if the Guidelines themselves link generic and brand names?
Because guideline recommendations tend to specify the non-proprietary name. Some have expressed a desire not to be perceived as endorsing a specific brand. It does NOT make a difference if the guideline links the proprietary and non-proprietary names. However, the answer does change if the guideline recommendation itself only cites the brand name.
A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.
You can describe the change in TMA in an accurate fashion. This may include a side-by-side presentation of the prior indication copy compared with the current content. Clarity is of the essence when doing so. All provisions in the code apply but you must be cautious not to accord clinical significance to the change (e.g. by attributing a reason to the change, by presenting possible consequences of the change, etc.)
Patrick Massad
Deputy Commissioner
Pharmaceutical Advertising
