Hello, I'm planning an OLA and I would like to communicate this unbranded, not search engine (Google) indexed and not gated event registration page (but unique password and link needed to attend the event) through a 3rd party. If the 3rd party can guarantee that non-HCPs and non-Canadian HCPs cannot access the content or receive a communication from them (we would need something to have written proof that we did our due diligence on that end), is this sufficient from a PAAB perspective to use this 3rd party as a channel to drive Canadian HCP traffic? Thank you Bill
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?
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.
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)?
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 you advise if this previously-approved TMA data can continue to be used in APS? Note, the data does not appear in published studies and is therefore considered Data on File.
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')?
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?
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?
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?
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 treatment of arthritis, it has been shown to be effective – otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.
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?
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 know whether a product is available through SAP.
Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required?
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?
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 by « xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder. » Here is an example of what I suspect does not need to included: bullet point « cognitive and motor disturbances » if PM has « cognitive and motor disturbances » bolded followed by « The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated in the xxx development program. » Please advice if my assumption is correct. Thank you.
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 change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation, which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?
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.
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?
Are there any circumstances under which data from a reference arm could be included in an APS?
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 the word « New » from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product » is referring to?