Hello @username

Please see Q&A 647 .

@jennifer-carroll Thank you very much Jen!!

Hey @mbos

A balanced and complete presentation of the AE profile from the TMA which reflect the same content and context, would be acceptable.

Hey @fernand

Generally, promotion of place in therapy claims from consensus guidelines should be within the limitations of the indication and terms of market authorization. As it sounds like this is an off-label recommendation, it would not be acceptable. The Marketing Benefits Claims document also includes this definition.

@jennifer-carroll Thank you! 🙂

Good Morning @matt-s17

Apologies for the delayed response.

In addition to a letter from med/reg confirming that they are actual patients, the presentation would be required to include the statistically significant data from the study for the endpoint being presented. The images should therefore reflect the average response. It would not be acceptable to select images that show the best-case scenario for patients.

The pictures would also have to be disclaimed with “Actual patient. May not be representative of all patients.”. As with patient images, they should only appear in a clinical context and with the supporting data (e.g., if you’re going to place them on a summary page, the quantification will require repeating).

@fernand

Our previous response was provided with the understanding that Product B had a similar indication.

Where Product B does not have an indication at all, there can be issues with potential off-label promotion. It would be suggested to not use the Product B logo in Product A advertising in those cases. Use of Product B’s brand name could be considered when presented in the context of the PM for Product A, i.e. in a cautionary manner only. It should not be designed as co-promotion of Product B. As the respective indications and PM dictate how Product A and B can be presented, we suggest submitting for an opinion with the PMs as there may be nuances within that may not be addressed as a general question.

Eg. Product A is indicated for combination use with Product B for metastatic melanoma. Product B has no metastatic melanoma indication at all. If the APS is highlighting use in metastatic melanoma and includes Product B’s logo, this would be considered off-label promotion for metastatic melanoma as Product B has no such indication.

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.