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Non-comparative experience claims relating to # of patients (or patient years) can be supported by either by providing worldwide/Canadian data or by providing a letter from the sponsor's med/reg department confirming the claim. However, market share claims (such as #1 dispensed...) require independent data (e.g. from IMS/Brogan) which meet the market share guidelines which can be found on the PAAB website.
Are unbranded printed materials focussing on disease area with no mention of drug treatments and that are presented to Health Care Professionals by Sales Representatives exempt from PAAB review?
It is exempt if ALL of the following are true:
It is not exempt from PAAB review if one of these is not true.
The unchanged product monograph on a corporate website is not considered advertising (provided of course there is no link to product promotion/advertising). In my experience, there would be little reason to create a stand-alone website for an unchanged monograph. In the context of a stand-alone product site, we are inherently promoting a product (would require gating). The landing is inherently promotional (within name, price and quantity of course). Besides, why create a website for something that is already on your corporate website. Something does not add up here. Call me if I've misunderstood your question.
In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*
For the PAAB submissions requirement for referencing advertising claim in an Advertising/Promotion System (APS), each claim or presentation would need to be accompanied by clear identification of the reference source as well as the relevant section and page number within the reference source where the claim is located. Additionally, the referencing copy should appear in a different colour from the advertising copy, and the corresponding section of the reference source highlighted and labeled. As an example: "My product was tested and found to work." 1,* [Ref 1A, p.50].
In this example Ref 1 - refers to the reference number, A – refers to the section of the reference where the claim is located, and p.50 refers to the page number of the reference source where the claim is located. The choice to include the AMA format in addition to the PAAB APS submissions requirement format is optional.
No. The piece need only contain the indications relating to the promoted uses. Note that some claims promote all indications (thus requiring presentation of all indications). An example that comes to mind is "Product X has 3 indications" (i.e. the 3 indication would appear in proximity to the claim). If the claims truly relate only to the one indication per your question, that is the only indication which is required to be presented.
A tool meeting all the requirements of a Help-seeking announcement from the Health Canada policy document "The Distinction Between Advertising and Other Activities" (e.g. no mention of the company name or product) may direct patients to a web consumer brochure meeting all the requirements of that same Health Canada document. A consumer brochure may mention the company name.
Currently, our PAAB Approval Acceptance number consists of a maximum of 33 characters, not including the ID# preface, and is alpha-numeric in configuration with symbols.
Please see the example below for the configuration and explanation of each part making up the Acceptance number.
ID# PAAB/12345/D/E&F/11-2012-10-2013
ID# is the preface for the actual Acceptance number and is not included in the character count of 33.
PAAB is static within the acceptance number
12345 signifies the corresponding eFile number for the submission. The character # in this field will increase over time as the number of submissions to PAAB increases.
D signifies the Prescribing Information status for the submission.
E&F signifies the language in which the advertising piece has been approved. This character field may vary as some advertising pieces are approved in English or French [] therefore, this field will simply list the corresponding language letter equivalent E or F.
11-2012-10-2013 signifies the PAAB Acceptance Period. The # of characters in this field remains static as single digit months in the calendar are identified with a '0' in front of the numerical value for that month. Eg. 01-2012-12-2012. The first month and year listed in this field indicates the start date of the Acceptance period and the second month and year listed indicates the expiry of the Acceptance period. In this example, the Acceptance period starts on the first day of November 2012 and it expires on the last day of October 2013.
I hope that I have answered all of your questions. Please feel free to contact me if you have further questions.
In short, PAAB code section 6.4 applies to all materials destined for clinics that will be used by (or go through) health professionals. PAAB will layer the Health Canada policy document "The Distinction Between Advertising and Other Activities" onto the review for items which will be openly visible (whether in the waiting room or the examination room).
Let's now dive into the specifics relating to the "why" and the "how". The HCP is involved in the decision to place these materials in the examination room and they use these items in patient counselling. These materials are therefore regarded as having, in addition to the primary audiences of the HCP and the patient, a secondary audience - the healthcare consumer. Consequently, these APS are subject to the applicable sections of the Food and Drugs Act and Regulations, policy and guidance documents pertaining to advertising, and the PAAB Code.
Please keep the following in mind for materials openly visible to healthcare consumers within HCP-patient interaction areas (the first 2 bullets relate to your question):
In addition to considering PAAB code section 6.4 for all these tools, it is also important to consider PAAB code section 2.5. For example, the CMA has requested that PAAB ensures that images portrayed in APS reflect lifestyle best practices (e.g. helmets on bicyclists, life preservers on people in a small boat/raft).
The regulations are similar for the tools displayed in the waiting room. Keep in mind that tools intended for the waiting room sometimes migrate into the examination room (and vice versa).
The prescribing summary is needed if the tool is left behind with the HCP.
In these cases, it is sufficient for the prescribing summary to be included as one of the inserts in the carrier.
If the carrier will not be left behind, the prescribing summary is not required. In these cases, it is sufficient for the drug rep to have the product monograph on hand in case the HCP asks to refer to it during the visit.
If the intent is for product branded content to be distributed with the disease state piece, then the PAAB should be asked to review the disease state piece in a product branded context. The answer is yes only when this is done. The principle outlined in Q&A 232 applies to patient information as well.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
