In general, the letter should be signed by someone from medical or regulatory within the sponsor’s company. There may be situations where a different signature is required. This would be addressed during the review process.
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 email@example.com
The inclusion of the indication would prompt, at minimum, lowest level fair balance and would not be considered exempt.
If exemption is the goal, we suggest submitting for an exemption opinion (see Exemption Request Policy and Procedure). This will allow the reviewer to assess the content and determine if the piece is exempt, or advise on changes to make the piece exempt. The exemption criteria require that there is no therapeutic mention or promotional marketing message about the product. It’s possible to still have promotional marketing messages even if they are not therapeutic messages (i.e. labeled blisters to help track dosage).
When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.
Anything that implies that something is “new” would be bound to the one year time frame. As "news" can be defined as “a report of recent events”, this copy does tend to imply that the announcement is in regards to something new.
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).
Context has always been an important part of our review. But virtual booths introduce so much heterogeneity in functionality, document management structure, and linkage opportunity across different conferences that these contextual factors alone can cause APS which were aligned with the PAAB Code for one conference to be displayed in a manner which contravenes the PAAB code in other conferences.
Examples of important cross-conference differences include (just to name a few):
Whether the risk / safety disclosures are legible by default or require a click
Whether the document management structure includes the ability to add document descriptions
Whether the document management structure includes search functionality (and if so, whether sponsors can select keywords and determine what the search output states)
Whether there is a need to manage the potential for linkages to documents of entirely different regulatory status
Whether group chat can be disabled. And if not, which mechanisms are available to ensure the chat is consumed in the context of the needed risk disclosures.
Whether there are ways the sponsor can impact the pathway to and from the booth (and whether this can create additional contextual and /or linkage issues)
Most of these sorts of issues are new or amplified in the virtual context and they differ drastically from one platform to another. Clients who assume that they can simply collate previously approved content in a booth without consideration of the platform specific nuances are therefore taking on substantial regulatory risk. Every factor in the partial list above has the potential to cause approved content to be misleading and therefore in contravention of section 9.1 of the Food and Drugs Act.
What are we doing about this? INFORMING: We’ve been informing companies about these risks for several months, and we continue to do so. The work we’ve done on the communications front is paying dividends as we now regularly have conference organizers, and staff from pharma that deal with those organizers, proactively reaching out to us.
ENABLING STREAMLINING: We’ve been increasingly seeing and accepting virtual booth submissions that are intended to be used across different events. These require some forethought, on the part of the client, into how they can present booth segments in a manner that would not differ materially across platforms (with thoughtful consideration of the heterogeneity between platforms). It also requires proactive consideration about which functionalities they are likely to utilize in future events. This is increasingly realistic as companies have had the opportunity to participate in several virtual conferences thus giving them a better sense of the various platform document management structures.
MONITORING: We have increased our proactive monitoring activities. We’ve increased our presence in large and small specialty conferences alike. We are motivated to maintain an even playing field and we welcome insights about booth executions you come across that do not meet the standards of the PAAB Code of Advertising Acceptance.
No, the video is not considered exempt. If the review of the deck did not include the voiceover and/or there are any other additional features (e.g. animations, zoom, pop-ups, footnote presentation etc.), these could all impact the review. This video would require it’s own review.
It is possible to allow the doctor to choose aspects of the patient to build a patient case. However, variable elements which may be subject to quantification, would be required to have support within the piece. These are things like goal statements, comorbidities, concomitant therapy, consequences of the disease/condition, or observed outcomes. Also, undue emphasis (e.g. repetition, a common theme/trend, etc.) on any patient characteristic(s), would require product-specific support within the APS. This includes the “occupation” field if there appears to be a theme/trend related to this field.
Each permutation with quantifiable claims would require a separate submission.
Thanks for your reply. Makes total sense. The IMC ethics code for Market Research is quite brief so I appreciate you explaining the practical application. Agree with your conclusion, especially regarding breadth of audience, in this example.
This would be acceptable
This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion)
An assessment of the link and linked content would be made during the review process
Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered