Y
Thanks for your question.
If the device is a distinct Class I-IV “medical device”, it does not fall within the PAAB scope as defined in code section 1.3 and the definition of a “Health product” per PAAB scope in section 1.8.
If it is not a Class I-IV “medical device” and is an extension of the corresponding drug product, then the training material, directed to HCPs, would be subject to PAAB review.
Please also see PAAB Q&A #500 as well as this PAAB Forum post
@tmcm
Thank you for your question. The proposed APS does not meet exemption criteria as per Code section 1.5. It is considered a promotional message and would require PAAB review. As an advertising message, bolding may be possible depending on the context. The appropriateness would be determined during the review process.
Hi @lags
Thank you for your question. There are many factors that will affect the direction and use of both product logos in APS. This forum is not intended to address the specific and complex scenario that has been described. We suggest a consult meeting be arranged with PAAB to fully disclose the nature of the promotion and the content in the respective product monographs. We are unable to provide guidance without further information. Consult meetings may be arranged through our administrative team at review@paab.ca
Hi @abyscat,
In general, if a specific coverage criteria is broader then the product’s indication or terms of market authorization, it is considered off-label and not acceptable in advertising. We suggest calling PAAB or submitting an opinion if there is specific formulary criteria that may require further clarification.
Hi @alee,
Yes, radiopharmaceuticals are drug products that fall under the Scope of the Code. Please see Code sections 1.3 and 1.4, and particularly 1.8 (definition of “healthcare product” which is covered by the Code).
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).
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.
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.
In general, accredited CHE materials are not considered advertising when the conditions are met per the Distinction between Advertising and other Activities and as such, they are also exempt from PAAB review under code section 1.5. Linking the CHE website to a branded DTC banner, will render the CHE to be promotional in its entirety, i.e. pre and post gate. Should it be forwarded to PAAB, the entire site will be requested for review. Please also see our Guidance on which HCP materials require PAAB review”.
As the CHE content was created without the advertising regulations in mind, the more realistic path forward is NOT to link it to advertising. I suggest rethinking usage of the the banner ad.
Let us know if you believe we've misinterpreted what you have in mind.
@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.
