Hello @healthymind

This question cannot be answered as a general question. We would need to assess the TMA content, claim and data within the published study. We suggest submitting as an opinion for a formal review.

From a general question perspective, we refer you to the PAAB Guidance on Patient Reported Outcomes which outlines specific considerations for PRO, including specific domains/items comprising the PRO instrument.

Happy Friday @username

The PAAB interprets “pivotal trial” to mean that the study was important to this specific product getting the indication (not necessarily important to the therapeutic area overall).

Hello @username

Code section 1.4c states “The Code applies to Advertising/Promotion Systems generated by advertisers or their agents, wherein the advertiser’s product or a competitor’s product is cited by either trade name or non-proprietary name. This includes any identifiable branding element.”. As such, the dosing for products which should be used in combination with the sponsors product, are required to be aligned with their respective TMA. If the products label does not align (i.e. not indicated in the specific population of reference), the sponsor should limit the copy to directing the HCP or patient to the respective labelling of the products which can be used in combination.

We could provide a more specific assessment in the context of an official opinion submission, providing consideration to all factors that pertain to your particular case (e.g., precise wording in monograph, planned level of specificity of provided dosing info, particular references intended to be cited, and so on).

Hi @dj,

In general, there is no distinction between what manufacturer employees post on a company account and what they post on their own personal account for company unbranded campaigns. A post that contravenes the Federal regulations on a company account likely contravenes those same regulations on an employee’s personal account. Additionally, even when a post is aligned with applicable Federal regulations on a company account, it may be a contravention on a personal account as the context may differ substantially. Ultimately, the company has not curated the content on the employee’s a personal account to ensure the overall context and linkages are appropriate. Posting (branded or unbranded) campaign content blurs the line between corporate and personal accounts. We encourage manufacturers to set internal social media guidelines that convey expectations vis-à-vis social media activity of their employees (and their agents).

@Kiki

Thanks @palanski for the thorough answer. Your response is accurate and complete.

@laurelea

Good question. In the same context as described in your previous question Rep triggered e-mails | Forum, a similar principle would apply to the naming conventions for clinical reprints attached to an RTE. Assuming the naming convention is claim-neutral (e.g. Smith, NEJM 2015) as per your example, fair balance would not be required. However, study acronyms are considered different. We review naming conventions in a similar way to subject lines or small space ads, so the RTE would require the appropriate fair balance (level of balance TBD depending on the specific language used in the naming convention) if they contain more than one of the following elements: product name, study endpoint or study name (i.e. study acronym). A combination of more than one of these elements has the potential to allude to a message/claim that requires fair balance.

Hello @Laurelea,

You are correct. If there are no brand-related claims and no reference to therapeutic use, it would be acceptable to not include fair balance within the piece if the document titles are neutral and claim-free, as per your example. For further information on naming conventions for email attachments, please see PAAB : Resources : Document names and descriptions for external use. Please note that the emails would still be subject to PAAB review as they link to advertising. For more information on the submission of email templates, please refer to Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context (in particular, the Dissemination section).

Thanks!
Danielle

@donna

Thank you for the clarification. We will set aside the banner ad for a moment and address the collection of accredited CHE on a gated section of a corporate sponsored website first. It is important that this method of distribution / dissemination of the CHE meets the accrediting body’s regulations (possibly including approval by the body). Also, if there is any content in addition to the accreditor-approved library of manufacturer-sponsored CHE on the website, that website likely requires PAAB review. At the very least, the website framework should be reviewed.

With regards to the non-product branded banner ad, when understood that it meets the accrediting body’s regulations (possibly including approval by the body), it would not require PAAB review if the website did not require review. If there was any content in addition to the accreditor-approved library of manufacturer-sponsored CHE on the website, then the banner would be assessed as part of our review of the website framework.

This sort of scenario is multi-factorial. If there are additional factors you’d like us to consider regarding this initiative, please submit an advisory opinion.

@kshulist
Yes, two brands can share a landing page. It does not matter regarding the indications as they should not appear on the pre-gate portion of the website as per the Food and Drugs regulations, C01.044. The regulation does not permit advertising of prescription medications to the general public beyond name, price and quantity. The content on the page should also meet this regulation.

Hi @gbrl88

The NOC/C box should be accompanied by the full indication as per the respective product monograph. Please see our guidance document regarding NOC/C requirements in advertising, Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOC/c. Please also see PAAB Q&A 619 regarding potential exempt messages with an NOC/C product.

Happy Friday @georgian21

PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.

Hello @skw

The fact that a website is created and controlled by a drug manufacturer’s parent company, outside of Canada, does not in and of itself render it exempt from Canadian drug advertising regulations (and the PAAB code). Even if the website URL is provided in a reactive manner, that website is likely subject to the regulations since the information that is available on the site far exceeds the question that prompted the URL to be shared.

The proposed activity could be considered exempt from the PAAB Code, PAAB Preclearance, and Canadian regulations if the mechanisms outlined in Q&A 176 were implemented. These mechanisms are provided to ensure the information provided is in response to the specific question asked. If all guiding principles from Q&A 176 are followed, this could be considered.

The PAAB can provide guidance on setting up a platform such as this, in the context of an opinion file.

As a reminder, one key aspect of the mechanism outlined, is “restricted access”. Canadians who are not HCPs must not have access to the site.

Hello @username

It is likely that this would be considered advertising and not subject to the exemption criteria outlined in Section 1.5D of the code which state “Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages”. The promotions of advertising tools would be considered a link to promotional messages. When we link advertising to non-advertising, everything becomes advertising.