• The new PAAB guidance on virtual booths has been a challenging process. What becomes most frustrating is that in participating in key specialty medical conferences, there are PAAB companies that have chosen not to submit their booth for review with PAAB on the basis that materials included in the booth have been previously approved by PAAB. This creates inequity booth content. How is PAAB addressing this?

  • Great question @tmcm

    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.