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Ask PAAB

YOUR QUESTIONS? ALL ANSWERED

Ask PAAB is a question-and-answer system that allows you to ask questions anonymously to PAAB. They then post their answers in this archive on a periodic basis. If your question requires more immediate attention, we encourage you to contact PAAB directly. Please ensure that you ask your question in English. To view the PAAB Code of Advertising Acceptance, please click here.

Questions updated to: October 4, 2021

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814

Can an employee of a member company distribute a QR code that is linked to a recent Real world Evidence poster presented at a medical conference? The QR code links to an update to the published 1 year data. The data is on label and consistent with the PM.

This would be considered an advertising activity and should be reviewed. From our understanding of the question, the data would not appear to be published and peer-reviewed and thus would not meet 3.1.2. Even if it were published and peer-reviewed, RWE is currently limited (in promo contexts) to presentations that confirm the results of RCTs. So this does not look doable.

813

If our company is displaying at a conference are we allowed to have unbranded tools that have information on the disease state while at the same time having branded information available (Ie dose cards etc) for delegates?

When you link branded and unbranded, everything becomes branded. Having both a branded tool and an unbranded tool at a booth, renders the unbranded tools branded. Having unbranded tools at a branded booth (even if there is no branded materials being handed out), still renders the unbranded tools, branded. See PAAB MYTHS 1 and 7.

812

We are exploring the use of a 5 year extension study in branded APS that is not included in the sponsor’s TMA. This is an extension of the original study included in the sponsor’s TMA. If the only methodological discrepancy from the initial pivotal trial is that the primary endpoint of PFS in the extended duration analysis was evaluated by Investigator Assessment, whereas the PFS presented in the original pivotal was determined by blinded, independent, central review (BICR), would the extended duration data be viable in a branded APS?

Please see Extension Study switching from blinded IRC assessment to unmasked investigator assessment.

811

In a virtual delegate bag, provided to HCP's at conferences are we able to include an invitation to a sponsored symposium or talk? Where am I able to find the criteria for delegate bag inserts?

There are no “specific” criteria for delegate bag inserts. When creating a delegate bag insert, one should consider: What is the message? What are the linkages? Are the linkages acceptable? A message that includes a brand and then directs the user to a sponsored symposium that is deemed to be medical information, may not be acceptable as this would be considered an advertising activity linking to a non-advertising activity. When we link advertising and non-advertising, everything becomes advertising. The symposium would now have to be reviewed in the context of the brand. Using a branded delegate bag insert to direct a participant to a PAAB approved slide presentation, would likely be ok. To facilitate the review process, it is beneficial to include all copy on the insert, a description of the linked content, and any additional sponsorship or linking factors.

The Guiding Principles for Digital Conferences document, provides additional information. The principles of the code apply equally in virtual and live advertising.

810

How much time does MAH have to update the existing PAAB approved APS that are still effective after a new version of Product Monograph has received NOC.

Please see Q&A 377, 485 and Update of APS per new boxed warning in PM.

809

Can a Pharma company give t-shirts with product logo on it to their employees for their personal use?

This would not fall under the scope of PAAB.

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