Hello @kbernard Providing the published study meets PAAB requirements as a standalone trial, as a general rule of thumb, if the timepoints are predefined, tested for statistical significance, and are directionally consistent with the primary endpoint, it would be acceptable to present them in the piece in a non-selective and complete manner.

Hello @mhe This sounds like a specific question about a specific study and product. It would be difficult to speculate on the features of the study, the brand, the claim and the nature of the device. We’d suggest submitting for an opinion. In general, published, peer-reviewed, randomized control trials are required for therapeutic claims. In-vitro studies can be considered for non-clinical claims if the study is published, peer-reviewed and designed for the feature being discussed.

Hey @constance Due to their size, we often receive a portion of the report. The advertiser must include any content that is relevant to the APS presentation in question.

Hello @geoffls20 The document Guidance on Patient Reported Outcomes provides the limitations for use of PROs. It is not required that the study identifies it as a “key” secondary endpoint. Note that it must be identified as a “secondary endpoint” and this must be disclosed in the APS per code section 3.1.10. The discloser of failed secondary endpoints is required when they are closely related to the other endpoints so as not to be selective. (s.5.12)

Hello @mhe Good question. Basically, all copy in a branded piece has implications for the brand. When you present the definition/criteria for “optimal benefit” you are suggesting that the product gets patients to “optimal benefit”. This is likely not substantiated as the clinical endpoint in the study was probably not “optimal benefit”. Claims, both direct and implied, must be supported by statistically significant findings from a well designed, published study. With respect to adding a disclaimer, it is not sufficient to state or imply claims and then use a disclaimer to off-set them. That which cannot be supported should not be stated or implied. Happy Holidays!

Good morning @palanski Great question. There has been an increase in HCP assets that direct HCPs to pre-gate spaces containing consumer content. For transparency, when you are directing this audience to a message not intended for them, they should be made clear of this fact. URLs that direct HCPs to landing pages that contain only administrative messages such as “log in here” would not require this disclaimer.

@jennifer-carroll Thank you for your helpful response!

Hello @username No. Code section 3.1.1 states: Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable.

@jennifer-carroll thank you Jennifer!

@jennifer-carroll Thank you this was very helpful

@jennifer-carroll Thank you for your input, Jennifer! We'll take this all into consideration.

@natbourre All materials should be reviewed and approved by the manufacturer’s medical department prior to submission to PAAB as per the efile submission form and Code section 1.6B3. However, this does not negate the requirement to annotate the references to facilitate PAAB review of the APS against advertising regulations. Please see our new guidance document for the submission process for directions on referencing.

Hey @hannah Please see Q&A 338 listed above.

Good morning @gmc PAAB has issued advisories and guidance regarding formulary claims since 2010. In addition, we have received feedback from formularies regarding the presentation of formulary coverage in APS since then. The 2010 eFile may not reflect the more recent information and should not be used as precedent. We suggest submitting for an opinion should there be more specific questions regarding the proposed project.

Hi @abyscat, In general, if a specific coverage criteria is broader then the product’s indication or terms of market authorization, it is considered off-label and not acceptable in advertising. We suggest calling PAAB or submitting an opinion if there is specific formulary criteria that may require further clarification.

Hey @charlton No, a patient case is not required to be on a patient who actually participated in the PM trial.

Hey @kshulist This sounds like a specific question about a specific file and issue. It would be best addressed by discussing the specifics of the request with the reviewer of the file, in the context of the actual claim and indication, particularly since there are additional considerations for exclusivity claims. As a general principle, claims with the phrase “…indicated for…” require the verbatim indication, whereas non-verbatim/truncated indication claims may appear as “…indicated in…”. A “first and only” claim like that described, would appear to be an indication comparison and therefore require the copy “indicated in/for”.

Good Morning @username To set the context of the response, please see Q&A 500 . If the copy falls outside of the scope of the PAAB code, we can provide an advisory response on content. To support instructions for a demo device, we could consider a letter from medical confirming that the instructions are accurate per how they would counsel an HCP should they contact medical for directions on use. No copy should contradict the product labelling or package insert and clinical conclusions should not be inferred.

Hey @username In the context of a study design, with no additional weight that would emphasize the endpoint, it would likely be acceptable to mention the endpoint.