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PAAB Code

Do you have questions about particular sections of the PAAB code? Do you have insights on how sections of the code be improved? Do you want to share insights about how related standards are addressed in other jurisdictions? Post here.

86 Topics 200 Posts
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
  • Outdated indication

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    Jennifer CarrollJ
    This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”. Let’s look at a few examples of where it would not be acceptable. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph. If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)
  • Calculations based on PM/pivotal trial data

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    M
    Thank you so much for your response!
  • Ongoing Trials & Investigational Drugs

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    Jennifer CarrollJ
    Hey @ALee Please see Q&A 223 & Q&A 713. These were found by searching “ongoing”. If you select “in titles and posts” you may find additional past questions relevant to your question.
  • RAMQ criteria vs. notes

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    Jennifer CarrollJ
    Hey @ALee The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.
  • Guidance on which HCP Materials Require PAAB Review

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    Jennifer CarrollJ
    Hey @mimi77 Yes. It would be considered discussion of drug therapy or content relating to drug therapy.
  • Consensus Guidelines

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    M
    Hi @Jennifer-Carroll , thank you so much for confirming!
  • Clinical Guidelines

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    Jennifer CarrollJ
    A sale representative may leave a physician a full, unedited copy of a published, authoritative consensus guideline for a given condition. Please see the linked document on “What constitutes current medical opinion and practice?”. Depending on the nature of the visit, please also be reminded that distribution of material by a sales representative may constitute an act of advertising and should adhere to the advertising regulations, e.g. product specific guidelines on off label use would be a violation of the regulations.
  • Fair Balance required for email linking to clincial paper

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    Jennifer CarrollJ
    Good Morning @Jennifer_CM Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).
  • Promotional activities on-line

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    P
    Jennifer, thank you very much for your prompt answer. We will do that.
  • Prescription Pads/Tools

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    Jennifer CarrollJ
    Hey @GMC This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".
  • Unbranded Patient and HCP APS

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    Jennifer CarrollJ
    Hi @caitlinbyrne When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.
  • Placing PSP enrolment forms on patient websites

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    L
    @jennifer-carroll Great, thank you!
  • Imagery

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    T
    @jennifer-carroll said in Imagery: which exceeds name, price, and quantity, this copy should be blurred to prevent advertising to the general public. Thank you!
  • The use of secondary endpoints with nominal p-values

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    L
    @jennifer-carroll Amazing, thank you so much!
  • Separation of patient consent information on a PSP form

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    L
    @jennifer-carroll Thank you very much for the very comprehensive and helpful response!
  • Use of descriptive statistics

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    Jennifer CarrollJ
    Hey @cchristopoulos Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.
  • Retargeting and Digital Media (ads)

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    Jennifer CarrollJ
    Good Morning @alee What a great question. This one got us thinking. We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.
  • Guidance on Patient Reported Outcomes

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    Jennifer CarrollJ
    Hi @alee A non-inferiority test that results in a "statistically non-significant difference" is a form of statistical analysis and would be required to support such a conclusion, and it is not appropriate to conclude non-inferiority (or similarity) based on nonsignificant test result in a study designed only for superiority as noted in the Guidance Document for Claims Based on Non-Inferiority Trials. The appropriate interpretation of this observation is that the test product failed to achieve statistical significance for superiority (i.e. it would not be considered a “positive clinical outcome”), which does not support a claim of “similarity”. Please also note that all clinical claims must be pre-defined, directionally consistent with the primary endpoint (confirmed through statistical evidence), and similar to the description in the domains section, overall scores require statistical significance as per sections 3.4, 3.5 and 3.6 of the Guidance document for the Use of Patient Reported Outcomes in Advertising, respectively .
  • This topic is deleted!

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  • Use of actual patient images

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    Jennifer CarrollJ
    Hey @laraholmes All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.