Electronic media

A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too? If this […]

Would materials used to train Healthcare professionals prior to using a product be items to be reviewed by PAAB, or do they reflect more Continuing education materials? The trainings would be done on site by medical science liaisons. Please refer to the response provided for Question #403. The concept of push vs pull discussed in […]

We have a situation where previously-approved clinical data in our TMA has been removed. This was an editorial request from Health Canada, simply to make room for new content (as Health Canada often requests trade-offs in order to keep TMAs succinct). It does not reflect a change in approval of the data itself. Therefore, can […]

We understand that a 'Made in Canada' claim can be made for a drug manufactured in Canada. Would the same be true for a drug first discovered in Canada (ie. 'Discovered in Canada')? The statement could be considered if you can support that it is accurate and not misleading.  Keep in mind that a product […]

We run a website that contain unbranded disease awareness information as well as unbranded drug information. Are we permitted to leverage our website to run targeted ads that link to sponsored DIN-gated sites? Linkages can alter the regulatory status of the individual elements they link. If I am interpreting your question correctly, it sounds like […]

If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products? See PAAB code section 7.4. Based on the information in the question, the answer is no. But please note that the piece still requires […]

We have a non-prescription drug and we plan to leave coupons for patients in the doctors' offices. Do the coupons need to be PAAB approved? No.

Hi Patrick, I have the following question: When using the terms “proven efficacy” in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, “Product X has proven efficacy in the treatment of Arthritis.” If the product has received an indication for the […]

Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner? I assume you are asking whether you can support a statement like X% of patients with condition Y have characteristic Z.  Patient support program enrollment data would not meet the standard level requirements for […]

It seems that materials that cite a product is available through the Special Access Program would be considered promotional. Are these types of materials reviewed and approved by PAAB, or are they strictly prohibited as alluded to in the Health Canada Guidance regarding special access programs? Without some notice, I don’t know how healthcare professionals […]

Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required? For non-prescription products, we have considered the claim based on robustly designed surveys published in healthcare professional journals. We have not accepted the claim for prescription products.  For prescription products, the answer is no. Claims relating to recommendations […]

I have seen mixed messages as to whether PAAB review of prescription pharmaceutical advertising must be reviewed by PAAB. Can you confirm or refute that PAAB review is required? PAAB review is mandatory for industry generated opioids materials directed to or through healthcare professionals (e.g. advertising, risk management tools, patient information). It is voluntary for […]

In the “other relevant warnings and precautions” section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point ” seizures” if PM has “seizures” bolded followed […]

We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big […]

In a DTC Consumer Brochure discussing treatment options for a given disease, can narcotic treatments be included in a balanced list of treatment options? We are assuming a Consumer Brochure is not defined as advertising under the Narcotic Control Regulations s70. You are correct in that a piece meeting all the provisions of the consumer […]

I'm working on building an app for a pharma client. It's a companion for a drug they market. But I'm concerned that the review section in the App Store will put us at risk of being non-compliant. Do you have any suggestions to help? As the concern is that consumer generated content may contravene the […]

Are there any circumstances under which data from a reference arm could be included in an APS? Only one comes to mind. If the data is presented within the TMA. In this case, we would assess to ensure the same context and content.