Electronic media

771

Dear PAAB reviewers, I have a question regarding the « Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context » guidance – several of our clients have pulled back on rep visits to HCPs in-person in light of COVID and have asked us how they can disseminate DTC waiting room […]

673

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 […]

672

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 […]

676

Hi Patrick – Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)? Hello. The rationale for section 3.7 is that different formulations could cause products to have different properties. One should not assume that two product […]

677

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 […]

678

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 […]

675

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 […]

669

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 […]

667

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.

662

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 […]

663

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 […]

671

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 […]

666

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 […]

670

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 […]

664

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 […]

665

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 […]

656

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 […]

657

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 […]

658

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.

659

As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: « Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years ». It is our understanding that for any APS we are limited to one year of usage of […]

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