Hey @tk2022

It sounds like this might be a specific question about a specific case. We’d suggest submitting for review as the forum is guiding principles. Each case is assessed based on it’s merits in the context of all relevant documents. The answer provided below is with the caveat that it is a general response.

In general, an RWE study is not excluded from advertising based on a pre-planned evaluation of a subgroup which would be within the limitations of the indication. “Consistent with the TMA” with respect to patient population states “1.1.2 Patient population: The APS presentation must be derived from analysis of patients that fall within the indicated population and are aligned with any relevant contraindications from the TMA. In instances where an overall study population exceeds the product’s indication, it may be possible to present data from a pre-planned patient subset that reflects the indicated patient population or relevant subset thereof.”

Hello @tk2022

The feature of being phase 3b/4 does not in and of itself disqualify a study from either RWE or study duration.

@jennifer-carroll thank you so much!

Hello @jdilly11

PAAB code section 3.1.1 requires that clinical claims are based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. Unpublished data would not be considered sufficient. If a study has been accepted for publication and completed the peer-review process (i.e. final manuscript is approved and awaiting official publication), PAAB can accept a letter from the editor confirming the future publication of the manuscript as presented in the submission.

Hi @rlevit1

The PAAB does not have a single guidance document dedicated specifically to defining “consistent with the TMA”. While many of the principles of the CFL guidance can be considered analogous to PAAB requirements, we suggest referring to and applying only Canada-specific guidance, as ultimately this is the only guidance describing compliant advertising in Canada. Familiar principles such as scientific accuracy (Code Section 2.1), restriction to the approved use and population (s3.1), and appropriate communication of risk-benefit profile (s2.4) are all required by the PAAB code, among others; however, consistency with the TMA as a whole depends on the type of claim and/or evidence posited.

Some resources describing consistency with the TMA relevant to certain contexts include:

Guidance on Subgroup Analysis (https://www.paab.ca/resources/guidance-on-subgroup-analysis/) , Noninferiority Trials (https://www.paab.ca/resources/guidance-on-noninferiority-trials/), and Secondary Endpoints (https://www.paab.ca/resources/guidance-on-secondary-endpoints/) all describe consistency with the TMA specific to these analyses.

Guidance on Real-World Evidence/Data (https://www.paab.ca/resources/guidance-on-real-world-evidencedata/). Section 1.1 describes consistency with the TMA with respect to Real-World Evidence/Data; points 1.1.1-1.1.4 can generally be applied to any randomized controlled trial.

Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising (https://www.paab.ca/resources/guidance-regarding-duration-of-clinical-trials-used-as-reference-support-in-advertising/). Some principles in this guidance originate from the CFL guidance.

Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc (https://www.paab.ca/resources/guidance_on_advertising_for_drugs_with_notice_of_compliance_with_conditions_nocc_feb_2018_typofix_docxpdf/), which precludes inclusion of any studies or data not found in the TMA.

Hi @gmc

This would be considered a review question. Please submit for opinion or full review. Note that other copy and content on the page impacts the acceptability of a message. As a general guiding principle, content on the described landing page would need to meet patient, HCP, and DTC regulations (i.e. it would be subject to the applicable sections of the Food and Drugs Act and Regulations, Health Canada policy documents pertaining to consumer advertising, and the PAAB Code).

Hey @smurcar

We cannot provide a review over the forum. Claims around the approval process are generally restricted to factual statements about the current state of the approval. Note that it is not acceptable to promote the approval process in branded advertising per Food and Drug Regulations C.01.007. See this previous Q&A.

In reference to the sticker approach, we suggest submitting an opinion with the content you intend to use and the positioning on pieces (with examples) so that we may assess in the context of a complete picture. Given the outlined copy provided, it appears it may be appropriate to use a sticker to update pieces. The full review would cover the requirements for the copy on the sticker and the copy which would become covered on the revised pieces. We’d also need to assess if anything else changed in the TMA that may affect the piece beyond just the NOC status change.

@jennifer-carroll said in Unbranded APS on clinical study summary:

ly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three

Thanks for the clarification!

@jennifer-carroll Wonderful, thank you.

Good Morning @kshulist

In general terms, the linkage would have to be assessed to determine its acceptability. While it may appear to be less of a concern linking unbranded to unbranded, the linkage would be assessed during the review process where additional guidance could be provided in the context of the specific tool/message. There are scenarios where a deep link is fine and where it is not ok. For example, deep linking to a page which focuses on the sponsor’s product, even if it’s third party generated, from a sponsor generated unbranded APS, would not be acceptable. Apply general linkage principles to ensure that you are considering both the regulatory audience and content being linked.

Hello @kshulist

This answer is provided with the understanding that the nominal p-value is not in the product’s TMA. The application of the above would depend on why the p-value was nominal. It can be from different reasons and the nominal p-value may become a meaningless number if the assumptions of the statistical model used to compute it do not hold. Violating any of the varying prerequisites of a significance test might render the nominal p-value not acceptable. As such, the ability to present the data and the potential types of claims in an APS would require consideration of the statistical analysis. For the example in question, if a statistically significant p-value is nominal simply because it was unadjusted, a claim neutral presentation could be considered per the prior Q&A.

Hey @user123

Please see Q&A 674

Hey @kshulist

As per the principles noted in Q&A 508, if the published paper conveys a statistically significant improvement in the absolute risk reduction for the response rates (with multiplicity adjustments performed when required to manage risk of type I error), the NNT may be calculated.

Hey @ap

An unbranded piece that speaks to products which the patient is not on, would be considered consumer advertising. The activity above appears to fall under “Medical condition and treatment awareness material” (formerly consumer brochure) and as such would have to meet the requirements outlined in the Distinction Between Advertising and Other Activities document under section “Medical condition and treatment awareness materials”. This outlines that all options must be included (pharmacological and non-pharmacological).

The Product Monograph can be used as a reference for treatment formulation but would not support direct or implied comparative claims. The reference should not be listed in the piece as this would create a link between the brand and therapeutic use which is in violation of the Food and Drug Regulations.

Hi @vt,

This appears to be about a specific product and class. We would assess on a case-by-case basis considering the totality of the market. In these instances, we suggest going through the review process.

@mimic909

Generally, when the route of administration is presented as a claim of product merit (e.g. promotional claims such as “convenient oral tablet” or “subcutaneous injection for at-home use”) in an email envelope (i.e. subject line/preview text), it requires fair balance (FB). Please see our "Tips and checklist" document. This principle applies regardless of the dosage form appearing in the proprietary/non-proprietary name (e.g. “PrDrug X (examplumab for IV injection)”.

Hi @constance

Please see PAAB resource Provincial Formulary Coverage Statements

Per the guidance document, the requirement for full formulary criteria disclosure is dependent on the nature of the claim e.g. inclusion of coverage codes requires disclosure of the full coverage criteria. Criterion are usually restrictions for coverage and act as qualification. Criteria generally do not require disclaimers if they are consistent and do not extend beyond the indication. Per the above reference, the indication acts as the limitations for initial consideration. There may be scenarios where disclaimers may be requested. This would be a case based assessment.

Hey @dmauri

While it’s not an outright no, in the context of a branded HCP pieces a diagnosis should already have been made prior to consideration of the product. If a piece with differential diagnosis was to be considered, it would have to be overtly clear that it was to ensure the proper patient selection and there was no inference of off-label use.

Ref: Guidance on Branded Patient Information
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Hey @alee

No. There can be no mention of unauthorized products/investigational products as they have not yet received terms of market authorization. The discussion of ongoing studies is to demonstrate the company’s commitment to additional research of approved products.