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.
For consumer surveys which are meant to gather information about current knowledge/attitudes on a certain medical condition and contains no medical information, does it need to be submitted to PAAB along with the rest of the DTCI campaign? We plan to use the survey results as a means to tailor content that addresses some of the knowledge gaps/attitude of consumers. Thank you kindly.
PAAB provides an advisory opinion on DTCI pieces. Our guidance is provided based on our interpretation of the Health Canada policy document “The Distinction Between Advertising and Other Activities”. Preclearance of DTCI is not “required” per se (although it is recommended). However, when PAAB reviews DTCI pieces, we require to review all elements of the campaign as other elements may render the reviewed elements to become advertising.
Can you confirm whether Code sections 2.10.1 and 2.10.2 are mutually exclusive? For example, could an abbreviated indication appear with the first marketing claim in an APS, with the verbatim indication appearing elsewhere in the APS?
2.10.1 and 2.10.2 are not mutually exclusive. A statement conveying all boundaries of patient selection must be presented among (or prior to) the first set of marketing benefit claims in the APS. This statement may be the verbatim indication (thus satisfying both 2.10.1 and 2.10.2), or it may be some other statement identifying all boundaries of patient selection in an alternate format (e.g. “Only use drug X in patients who…”). In the latter case, the verbatim indication must still appear somewhere in the piece. Additionally, use of the statement “indicated for” should be restricted to the verbatim indication. Refer to the PAAB guidance document “Guidance on indication placement in advertising” for additional information.
Further to Question #177, does PAAB exemption also apply to Health Canada-approved patient materials distributed by an HCP in a risk management plan?
Health Canada has requested that risk management tools (whether targeted to HCPs or provided to patients through HCPs) be reviewed by PAAB.
We’ve secured confirmation from Health Canada that even in instances in which they reviewed and approved the content, their review is focused on scientific accuracy of the content. They have asked PAAB to review the pieces to ensure that they are not promotional. At the end of our review, PAAB sends the final piece to Health Canada for their records. Question #177 has been updated accordingly. Thanks for directing my eyes to this.
If patients have registered for a branded patient website (which has a gated landing page) and opted in to receive emails, can the emails direct them to a page behind the gate? Would this page need to be gated? Or, do they need to be directed to the gated landing page?
Yes the emails can direct them to a page behind the gate however you have to ensure they are still patients. Thus you should either have a revalidation process or a disclaimer telling recipients that they can enter if they are still patients. The onus is on the sponsor to ensure the target audience are patients prescribed the drug to avoid illegal DTCARx promotion. See Code s6.5 and the guidance document “Online Activities”.
For DTCI campaigns, are we allowed to focus on a certain stage of the disease? (For example, mild).
If this is DTCI with no product mention you can focus on mild disease because you are not doing product advertising and the advertising regulations do not apply. See the Health Canada policy document “The Distinction Between Advertising and Other Activities”.
Hello there, I am a pharmacist from ON. I noticed some advertising from Mylan that I think is risky/dangerous and reckless in terms of the message it may be sending patients, the general public as well as pharmacists. I was wondering if I can make an anonymous complaint through this portal and in general what is the process for complaints? Details below. Mylan created a Fentanyl patch passport which is being distributed to patients who are dispensed Fentanyl by pharmacists. I have also seen it in airports on counters. The overall concept is good where they want patients to return their used patches to pharmacies for proper disposal and once returned they will be provided their new prescription. Patients would attach their used patches to the passport to return to pharmacy for disposal and get dispensed a new fill of product provided they have a valid prescription of course. However, Mylan added to the Ad 1 statement that I believe is as mentioned reckless and dangerous: "To further reduce potential harm and misuse, some Fentanyl patches have less medication remaining in the patch after use. Talk to your pharmacist about your Fentanyl patch options." To imply that "further potential harm and misuse can be reduced" when there is enough residual Fentanyl left over to kill children and pets is risky. I don't know what studies have been done that demonstrates that there is less potential harm/misuse. First of all, the drug is released at the same hourly rate regardless of the amount of residual drug left in used patches and it may run out faster but can still be extremely harmful and could kill children, pets and those not use to Fentanyl depending on the concentration in the patch. We don't know if it gets into the hands of addicted individuals who wants to obtain the drug from the used patch through misuse like boiling the patch or chewing it, that their patch will fair better than those with more drug. It doesn't necessarily follow that the amount of residual drug released is more or less than any other patch without do the studies because the material may release more or less than other patches because they have different ingredients. I have not found any studies that prove their patch because it has less residual drug reduces potential harm and misuse. They don't have a PAAB logo on the Ad so I am not sure if PAAB is even allowed to investigate this but I would really appreciate your thoughts on this issue, because I think it is risky to make such unfounded claims. Do you need a formal complaint or can you investigate based on this request? What is the process for complaints? Thank you - I look forward to hearing back from you. Many thanks for your guidance on this issue.
Health Canada adjudicates consumer advertising complaints about prescription products and complaints about any type of advertising (regardless of audience) deemed to put the safety of Canadians at risk. Please direct your complaint to the MHPD (Marketed Health Products Directorate). The contact information is provided below.
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 0701L
Ottawa, Ontario
K1A 0K9
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
There is a unique provincial situation in which the manufacturer has lowered the price of its drug to match the price of its generic substitute. Can we create an APS that speaks to this fact and claim that patients can continue to receive said drug "at no additional cost* compared to the generic version."? *Refers to the drug acquisition cost; dispensing fees not covered.
A Q&A forum is not the optimal forum for this type of question as it requires a review. I will not speak to your particular case (as I don’t know the details). I will say that a message such as “at no additional cost” suggests that no patient ever needs to pay more than they would for the generic alternative. This claim is misleading unless it is unequivocally true.
As a result of a recent PAAB approval I believe that a branded APS may contain corporate messages if - the messages are not contained on the same page as the branded material - this new page containing corporate messages does not contain any drug branding - this new page containing corporate messages appears after the fair balance My questions are: 1. would the same rules apply, with regard to corporate messages, to a branded drug manufacturing video? 2. If so, could corporate messages be included at the beginning of the video, before introduction of the product and its indication statement?
A Q&A forum is not the optimal forum for this type of question as it requires a review. I would not know the corporate claim(s) nor would I know how the product is promoted in this piece. As I am sure you can appreciate, context is also very important. I’d also caution against generalization of your observation as it is likely impacted by factors I’ve listed and potentially others.
Note that the PAAB code does not prohibit use of corporate claims in a product branded piece. However, presenting the corporate claims in a manner which suggests an unsubstantiated product benefit or attribute would be misleading. If you’d like a preliminary assessment on your concept feel free to submit it for a PAAB opinion (see fee schedule on the PAAB website).
Upon reading the PAAB guidance it appears that we are able to put general disease information and general symptoms into a Patient booklet that is distributed to patients after they have been prescribed the drug. Is this the case?
Non-promotional disease information can be considered in product-branded patient information provided the disease information falls within the limitations of the product’s indication per the Terms of Market Authorization (TMA). The disease information should be supported by authoritative sources (e.g. guidelines, medical textbooks) or Standard Setting Organizations. Additional caveats that come to mind include:
For example, patient information often includes discussion of disease triggers in the context of lifestyle tips about how to avoid those triggers. This can be considered provided the discussed disease is indeed the disease the product is indicated to manage. This is NOT a complete list of the types of disease information which can or cannot be considered in branded patient information. We’ve merely provided a list of the issues which appear to come up most frequently when reviewing disease information for branded pieces. We remind everyone that there is a “Guidance on Branded Patient Information” resource available on the PAAB website.
I would like to do a price per month comparison of a number of products. The official indications may vary slightly and some of the products would be OTC and some prescriptions. Is this possible and do you have any advice. Secondly what are acceptable pricing sources? Thank you.
Per s5.1 of the PAAB code, the compared products must have an indication in common and the comparison must be related to that use. The variation in indication you’ve identified would therefore be cause for removal of at least some comparators.
As prices may vary by source, please note that all compared prices must come from a single independent source which is reflective of national price. This is to ensure a levelled field for the comparison. The commissioner has had to rule on complaints of selective sourcing of prices in comparative claims in the past.
The sourcing requirement and the indication requirement may make it challenging to include both Rx & non-Rx options. Additionally, some products would be associated with a dispensing fee while others would not. Plan accordingly when setting up the submission.
Although there are some circumstances in which it would be acceptable, cost per month might be problematic on multiple levels. For example, it might suggest a pharmacoeconomic advantage to the sponsor’s product (i.e. suggesting that treating the condition with this product for a month costs less than treating it with another option). Per s5.10.1, claims may not convey (or even imply) a value comparison based on price information alone. High quality pharmacoeconomic studies are required to support pharmacoeconomic messages. A per month basis may also inflate the differences between products in an undue fashion. For example, some options may require a less lengthy treatment duration.
When it results in a fair comparison, it may be advisable to structure the price comparison per dosage form (e.g. per tablet) instead. If this would be unfair (e.g. due to variability in dosing schedule), it may be advisable to structure the claim in terms of price per day.
Careful to use the term “price” rather than “cost” to further reduce the risk of conveying an unsubstantiated pharmacoeconomic message. Also careful not use auxiliary elements such as images or text which accord pharmacoeconomic meaning to the presentation.
Claims must adhere to all PAAB code provisions so you may wish to consider submitting a written opinion (see fee schedule on our website) when you have a concrete idea of how you’d like to proceed. I haven’t tried to foresee all potential issues so the reader should not assume this is an exhaustive assessment of the matter.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
