Skip to content

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.

85 Topics 197 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.
  • Ongoing Trials & Investigational Drugs

    2
    0 Votes
    2 Posts
    69 Views
    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.
  • Calculations based on PM/pivotal trial data

    2
    0 Votes
    2 Posts
    97 Views
    Jennifer CarrollJ
    Hey @megancouture In the context of a general question, there are cases where company-generated calculations may or may not be acceptable. For the specific examples presented, a review of the study design/statistical analyses/results would be considered in the assessment. We recommend considering the following Code sections: Code section 5.8 - Methodologies, endpoints and independent review. To be considered as evidence, clinical studies must use established research methodologies and validated endpoints. To aid in the assessment of these study parameters, PAAB looks for evidence that the full study results have been subject to independent review, such as that found by achieving the publishing of study results, including statistical analyses, in a peer-reviewed journal For the second example, we’d also advise to consider Code section 4.2.3 (principles of relative risk reduction [RRR] and absolute risk reduction [ARR]) and Code section 5.9 (statistical significance required for evidence).
  • RAMQ criteria vs. notes

    2
    0 Votes
    2 Posts
    637 Views
    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

    2
    0 Votes
    2 Posts
    397 Views
    Jennifer CarrollJ
    Hey @mimi77 Yes. It would be considered discussion of drug therapy or content relating to drug therapy.
  • Consensus Guidelines

    3
    0 Votes
    3 Posts
    618 Views
    M
    Hi @Jennifer-Carroll , thank you so much for confirming!
  • Clinical Guidelines

    2
    0 Votes
    2 Posts
    524 Views
    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

    2
    0 Votes
    2 Posts
    585 Views
    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

    3
    0 Votes
    3 Posts
    722 Views
    P
    Jennifer, thank you very much for your prompt answer. We will do that.
  • Prescription Pads/Tools

    4
    1
    0 Votes
    4 Posts
    1k Views
    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

    2
    0 Votes
    2 Posts
    564 Views
    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

    3
    0 Votes
    3 Posts
    696 Views
    L
    @jennifer-carroll Great, thank you!
  • Imagery

    3
    2
    0 Votes
    3 Posts
    744 Views
    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

    3
    0 Votes
    3 Posts
    770 Views
    L
    @jennifer-carroll Amazing, thank you so much!
  • Separation of patient consent information on a PSP form

    3
    0 Votes
    3 Posts
    724 Views
    L
    @jennifer-carroll Thank you very much for the very comprehensive and helpful response!
  • Use of descriptive statistics

    4
    0 Votes
    4 Posts
    1k Views
    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)

    4
    1 Votes
    4 Posts
    1k Views
    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

    2
    0 Votes
    2 Posts
    509 Views
    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!

    2
    0 Votes
    2 Posts
    29 Views
  • Use of actual patient images

    2
    0 Votes
    2 Posts
    617 Views
    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.
  • NOCc and Guidance on Duration of Clinical Trials

    5
    0 Votes
    5 Posts
    2k Views
    Jennifer CarrollJ
    Hello @dmauri The guidance does not apply to NOC/c products and therefore has no bearing on data reviews for NOC/c products. The standard NOC/c approach remains the same (see Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOC/c)). If the data or study are presented within the TMA, we will allow it in the same context within promotional pieces. When assessing copy similar to “the results of the extension study were consistent with those of the earlier analysis”, clarity on which endpoints and the same tonality and direction will be required. Additional comments may arise pending review of the language used throughout the TMA.