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.

@jennifer-carroll Great, thank you!

@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!

@jennifer-carroll Amazing, thank you so much!

@jennifer-carroll Thank you very much for the very comprehensive and helpful response!

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.

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.

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 .

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.

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.

@jennifer-carroll Thank you kindly for the response

Hey @afpjjim The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.

Hey @NatBourre When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario). It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.

Hi @theodora32 The provisions of pre-printed prescriptions pads are not addressed specifically in the PAAB Code. As a company-sponsored service oriented vehicle, PAAB will review the content of submissions with a prescription pad to assess its consistency with the TMA. However, it is the sponsor’s responsibility (e.g. medical/regulatory or legal departments) to do their due diligence to ensure that this activity does not contravene the regulations and codes of the respective federal/provincial regulatory bodies, health professional governing bodies and industry associations.

Hi @natbourre There is the ability to link to an unbranded survey questionnaire. However, as it is linked to a branded patient APS, the questionnaire would be subject to the PAAB code. As a reminder, linking unbranded to branded renders everything branded, so please be mindful that unbranded materials should not contain content which would not be accepted in a branded context. In addition, depending on the questions and if the answers/results are not intended for internal use only, the subsequent distribution of the results to patients or HCPs may be subject to advertising regulations as well.

Hi @maryssa From the description in the question, the ads are visible to the general public but they are designed for HCPs. As such, the primary audience are HCPs and the general public is the secondary audience. Consequently, the provisions of the PAAB Code apply, including the need for PAAB Preclearance. Because of the secondary audience, our assessment would also include the need to adhere to federal regulations pertaining to consumer advertising. Please ensure the submission letter conveys that the banner ad will be placed in pre-gate environments.

Hi @natbourre Please see Q&A 214. For anything discussing disease burdens, please also see our recent guidance document Guidance on the Presentation of Burdens of Disease in Advertising, specifically section 5.3.

Hey @laraholmes Assuming that all aspects of the code are met (prominence and clarity of messaging, balanced, complete, non-promotional to patients, etc.), this may be possible. Given the variety of factors that would need to be considered for assessment, including the size/dimensions of the piece, we suggest either submitting for an opinion and/or providing a preliminary mock-up of the piece when submitting for review to determine the plausibility of the proposed APS. Final ruling would be pending an official review.

Hello @maryssa Our understanding is that you are asking in reference to the “Renewal Management Dashboard" and a piece needing to be 100% pickup . In this context, yes, it would be acceptable to update the date to match the new TMA. Note that review to ensure that the piece is not affected by the TMA update would be required. If additional copy change is required to address the TMA update, additional fees and a new timeline may be applied.