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Hey @dmauri
Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada.

When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

Hey @JDilly11

Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.

Hey @mimi77
While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.

Hello @msargeant

Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Hey @HollyMed

Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.

Hey @HollyMed

Please see Q&A 593.

@Jennifer_CM
Example 3 appears to be about the product monograph web link destination. The original question above is about linking middle level fair balance to highest level fair balance. Linking middle level fair balance to highest requires that it’s within the same tool or directly attached. A print journal ad is not the same medium as a URL link (web based) and therefore would not be acceptable.

Hey @ALee
“Indirect link to a general formulary/Provincial homepage” is the same as “full formulary list of a province”. As per the response above, this would not be considered exempt.

Hi tk2022

Please see our more recent “Guidance on Real World Evidence/Data” for criteria and direction on the presentation of RWE in advertising to health care professionals. Please also see our "Guidance on the use of the Attention Icon" regarding unblinded data.

Hi @megancouture

Claims based on acceptable, authoritative consensus guidelines do not need to be verbatim from the reference. However, it must capture the recommendation accurately and within context. It must not impart a new or different meaning than the guidelines.

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.

Hello @dmauri

PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.

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).

Hey @Supriya

This appears to be a specific question about a specific piece. Copy around “new product availability” is broadly open to interpretation. PAAB would also need to see the third-party program site to assess the combination of all messaging within the piece and the linked content. We suggest submitting for an opinion.

Hey @Pauvian

Advertising in a consumer space must meet the consumer regulations (i.e. does not exceed name, price, quantity for prescription (Rx) products or treatments for schedule A diseases). We would advise against including the DIN as this is a standard mechanism for gating patient information. Including the DIN would require assessment of all patient sites for the product to ensure this list is not promoting the password to the general public.

Note that the question is in response to a “list”. The website appears to contain additional elements (such as pictures) which may render the site in non-compliance. We’d recommend submitting for an opinion in order to fully assess the complexities of the proposed activity.

Hey @Supriya

This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).

Good Morning @Constance
PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.

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".

Hey @mhouzer

The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

AI MODEL - Phase I Testing Opt-In Deadline!

@Manufacturer the Pharmaceutical Advertising Advisory Board (PAAB) is taking a significant step forward in innovation by launching the first phase of testing of our ground-breaking AI model on live files starting May 1st.

On April 1st, in preparation for launch, we sent an eblast to industry announcing the deadline for full opt-in was now set for May 1st. Manufacturers who opt-in after the May 1st deadline will likely need to wait until a sufficient number of additional opt-ins are accumulated. This grouping of late opt-ins is intended to support cost-effectiveness.

This initiative marks a major milestone in enhancing the efficiency, consistency, and effectiveness of advertising review processes for our industry. Ensuring that preclearance keeps pace with the speed and quantity of specialization afforded through AI adoption across the industry.

If you have not yet reached out to PAAB and want to be among the first to experience the benefits of this exciting new project, please contact info@paab.ca today.

@Agency we'll be reaching out shortly for your collaboration on the AI driven augmentation of the submission process.

Cheers
PAAAB