Hello @Manufacturer and @Agency .

Please find uploaded the completed Tag report and CEI report for Q4 of 2023. Please let us know if you have any questions.

Have a great week.

Hey @kshulist

An image that supports the evidence presented in the piece from an RCT, would be considered acceptable even if it was from a patient in an RWE trial. PAAB does not request confirmation that it is from a patient in the trial being presented who had the average response. The visual simply needs to reflect what would commonly be seen as “consistent with” the magnitude of effect demonstrated in the RCT.

If the evidentiary basis of support is the RWE, use of the images would not be acceptable.

@jennifer-carroll Thank you!

@palanski

We're so glad to hear your team is excited to use the new dashboard! We hope it makes tracking and resubmission more streamlined for everyone.

Hi @sonalip9

It’s an interesting question and at face value might seem rational to think an expiry is illogical. However, the regulatory landscape for pharmaceutical advertising direct-to-consumers is more complex than “name, price, quantity”. There are linkages to consider, the totality of marketing campaigns which change over time as well as continuously updated rulings from Health Canada on what is deemed to align with federal regulations. It may not be possible for companies to be aware of all review rulings and understand if they impact their DTCA campaigns. The expiry date encourages companies to stay proactive about regulatory compliance and reassessment to occur in the context of the current market and regulatory environment, not the market of 1, 2 or 3 years past.

If the concern is the cost and effort associated with maintaining a file’s acceptance status, we encourage you to utilize the new Renewals Management Dashboard. It was designed to help streamline your renewal submissions and track upcoming renewals. When a renewal is submitted 6 weeks or more in advance of the prior eFile’s expiry, it may be eligible for the early renewal discount, which is 50% off the associated full fee. Rest assured, if you renew early your new acceptance period for the new file will not begin until the end of the prior file’s acceptance period. You can learn more about the Renewals Management Dashboard here.

@jennifer-carroll Thank you !

Hey @kshulist

The guidance does apply in this scenario. In addition to the considerations identified in your question, section 4.2 of the guidance relating to emphasis is also applicable. There should be no emphasis on burdens upon which the product has not demonstrated an effect and it should be part of a balanced presentation that includes burdens upon which the product has demonstrated an effect. Clear and prominent disclosure as per section 5.2 of the guidance will be required and this may include clarification of the indication even if it has already been included elsewhere.

As a reminder, PAAB will be starting to review under the new guidance starting February 19th.

@jennifer-carroll thank you!

@username

Hello. As the example does not specify the product, we are unable to answer the question directly. The product, therapeutic area and Health Canada product schedule will determine which regulations apply in the DTC space. We direct you to the Food and Drugs regulations and the document Guidance Document: Schedule A and Section 3 to the Food and Drugs Act. It will provide clarification on advertising restrictions to the general public. Please note section 3 and 2.3 of the document regarding Schedule A diseases in advertising. Linking a DTC website even to an unedited PM may be a violation of the regulations depending on the therapeutic area. We suggest contacting PAAB for a general question call should you need further clarification. Please also note that the DTC site is considered promotional advertising so the Distinction document does not apply in this scenario.

@jennifer-carroll Thank you for clearing that up!

Hello @mimic909

The indication (and at minimum lowest level fair balance) is required for all pieces which have a link to therapeutic use or contain marketing benefit claims about the product both explicit or implicit (Code section 2.10 and 2.4). The “branch of medicine (ex. Hematology)” alludes to a drug’s therapeutic use and would require indication and fair balance. The document Tips_and_checklist_for_creating_and_selecting_fair_balance provides assistance for selection of the level of fair balance. Additionally, PAAB Q&A 303 highlighting the exemption criteria which “branch of medicine” would not qualify for, 317 on inclusion of the indication, and 740 provides another example of a claim that would prompt inclusion of indication and fair balance.

Hey @lora_nolan

Yes, the mentioned guidance applies equally to new products as it would to established products. The pre-NOC submission pilot is not related to this update. It is an administrative guidance reflecting a process change where we moved from requiring final draft TMA and only accepting 2 core pieces prior to NOC, to accepting submissions for review at any stage of the TMA development and with no limit on number of files (at PAABs discretion). Please refer to the pre-NOC guidance for fees that may apply in addition to the standard initial fee should a TMA update be made mid-review of a pre-NOC APS. There is no difference from a Code application perspective in how a pre-NOC review is applied. The duration guidance also applies to pre-NOC submissions. Once a notice of compliance (NOC) is granted for a product, an APS for the product may contain claims noted in the study duration guidance that are related to “out-of-TMA updates” to TMA studies (these would be data from TMA clinical trials that are not mentioned in the TMA), if these claims and their supporting studies are consistent with the TMA, are pre-planned, published and peer reviewed, and do not pertain to NOC/c products or Class B opioid products. Section 1a of the guidance provides further details for this specific scenario.

Hello @kshulist

From the information provided, it appears as though the formulary criteria are not overtly off-label. However, we would first have to see the TMA and listing in order to analyze the restrictions regarding the higher dose for the two mentioned populations. The rationale is that, based on your description, if the “15mg” and “30mg” in the formulary listing is presented only in the context of the available dosage strengths covered for the drug rather than dosing directives, it would not appear to be considered off-label. In the latter case (i.e. formulary listing appears as dosing), the dosing in the formulary appears broadly stated but can be easily limited by inclusion of the TMA dosing recommendations. It would be different if the formulary listing stated overtly “30 mg for use in patients 12 and up” which is off label. It’s likely, given no other issues with the listing, we would simply request the indication as well as the dosing recommendations for the two mentioned populations be presented upfront, as body-copy in the APS, prior to the presentation of the formulary criteria to establish the context.

Hey @matt-s17

This question appears to be about a specific product with specific considerations which are hard to anticipate in a general context. Part 3 of the Market Authorization Holder’s (MAH’s) TMA and the information/statements it contains regarding the use of the other therapies will help determine what may be included in a patient brochure. However, in general, a patient should not be exposed to product information for a product they have not been currently prescribed. It may be possible to discuss two products in a single piece if it is clear upfront that the piece is intended to only be distributed to patients currently on both products. An additional consideration is that the content must be within the limitations of the MAH’s TMA. Off-label content from other TMAs would not be considered acceptable. Remember to keep patient information non-promotional and see Q&A 573 for some additional guidance.

We’d suggest submitting for an opinion where you can provide more context for assessment.

Hello @dmauri

For a non-comparative claim regarding patient satisfaction of a patient support program (PSP), PAAB could consider data on file from the manufacturer. In other words, the sponsor’s lack of involvement does not apply in this case. The survey methodology, data, and analysis should be submitted for consideration to assess the question which may impact content required in the APS. PAAB can provide an opinion on the questions in advance (in the context of the anticipated claims) to ensure that they are asked in a manner that would be considered acceptable. As an example, it must be clear that the question is about the program and not the product or outcomes/effects of the product. Satisfaction with the program cannot be extrapolated to satisfaction with the product.

Hello @emc070

“Trusted” accords a status to the HCP’s choice to prescribe. This has both efficacy and safety implications which are not substantiated. It would also not be acceptable to equate a HCP’s choice to prescribe a product to their “trust” in said product. This type of claim would not be acceptable. Remember that market experience data should not be given clinical implications or equated to “trust” in the product.