Hello @username

The copy “Proven efficacy” CANNOT stand on it’s own. It must be immediately supported by the indication which sets the limitations of the copy ”proven efficacy” as assessed and authorized by Health Canada. The indication acts as the ‘supporting copy’. The copy “proven efficacy” should not appear above single study findings as it overstates the level of evidence of single past tense study findings.

“Proven safety” is not acceptable since it is absolute. One could use the copy “Proven safety profile” if it is immediately supported with the most common adverse events and percent incidences from the PM. This reflects the safety profile that Health Canada has assessed in order to grant market authorization.

Note that either example "Proven efficacy" or "Proven safety profile" would also prompt the inclusion of the highest level fair balance.

Good morning @karen-taylor

It is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. The addition of a new boxed warning would be considered significant and require the proactive update of all pieces in a timely manner. See also Q&A 337

Good Morning @tmcd

No, this would not be considered exempt. It goes beyond a simple sample availability message and the communications are in reference to a service being offered for the purposes of the distribution of the brand(s). Therefore, they are subject to the advertising regulations.

Hello @danielle

A letter from legal confirming that this is the case would be required.

@jennifer-carroll thank you

@jennifer-carroll Thanks - Appreciate the reply!

Hello @sil

There are ways in which a company can create content which speaks to a disease state they may not yet have a product in.

An institutional APS can convey that the manufacturer is committed to conducting research in a specific therapeutic area. They must not contain or imply any product claims, or state or imply that a new product or indication is coming soon. These pieces should be submitted to PAAB as they relate to investigational drug research.

An editorial APS which is intended to increase the HCPs awareness and understanding of a therapeutic area is acceptable. The APS should not contain the message that a new product (or indication) is coming soon as this would contravene section C.08.002 of the Food and Drug Regulations. Even if pharmacotherapy is not discussed, pre-NOC editorials about physiology or pathophysiology should be submitted as they relate to investigational drug research.

As a cautionary note, creating an entire editorial campaign may be considered pre-NOC advertising as this changes the frequency of messaging and breadth of formats/media used to convey the content.

Audience is always a consideration and the type of message will impact whether it can be presented to the general public or will require limitations to HCPs.

While it is acceptable to make reference to a disease state on the company social media, be cognizant of the fact that there should be no link to the product in development. If there are other posts about ongoing trials, recently reported findings, investment in treatment for this therapeutic area etc., this may be considered pre-NOC advertising. Standard monitoring and moderating requirements would also be required.

Good Morning @ali

Assuming that the manufacturer has vaccines, this message inherently promotes the sale of healthcare products which it has a vested interest in. Exemption criteria in 1.5E of the PAAB Code is for corporate messages that do not contain product information or product lists. Mention of vaccination is a message about a healthcare product. This piece would not be considered exempt.

Hello @username
If the endpoint in the study is one that would not be acceptable for presentation within the piece (such as an exploratory endpoint), it would not be acceptable to mention, even in a claim neutral manner, regardless of whether the study was open-label, double blinded, single-arm, or placebo-controlled.

Good morning @karen-taylor
The following is a review of the concept that you’ve proposed and not a line-by-line review of the copy

It is acceptable to promote coverage that has been granted and is within the limitations of the indication. The promotion of a request for coverage may suggest that the company expects coverage for the criteria or indication listed. This would be speculative (as provinces may elect to follow the coverage recommendation or not) which would not be acceptable in advertising. Please also note that use of the CADTH and INESSS recommendations would not be acceptable in advertising as these are intended to inform provincial decisions to cover or not cover. They are not intended to guide HCP treatment decisions.

Hello @healthymind

As per the response to PAAB Q&A 308, the PAAB code section 1.5 defines "personal correspondence as" single letters carrying a personal response or message. BUT it goes on to explain that this exemption does not apply to multiple personal letters initiated by the company. The above mentioned activity would not be considered a person-to-person communication. It is possible that the message is exempt from PAAB review even though it is not considered a person-to-person communication. However, it is also possible that some aspect of the activity discloses a therapeutic message, such as the content of the representatives business card or product logo. For this reason, we suggest an opinion to exemption review.

PAAB Q&A: Mention of new indications in 1X1 email to HCP may also provide additional learnings.

Thank you @Jennifer-Carroll. Appreciate the additional clarification. Helps to have this in writing for alignment across various stakeholders. 🙂

Thanks @Jennifer-Carroll!

Hey @NatBourre
As per Q&A 529, “Study findings which are not presented in the TMA (whether because that study is not in the TMA or because the portion of the study in question is not in the TMA) can be considered in drug advertising provided the study meets all provisions in the PAAB code and guidances”. Some elements to consider are that the outcome is consistent with the indication and outcomes presented within the TMA and that the reference is a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure the outcomes. Components of the study which would be considered outside of the limitations of the indication would not be considered.

Hey @NatBourre,
A balanced presentation of the treatment guidelines can be considered in an non-branded APS when there are multiple treatment options either within one category or across multiple categories. The distinction is that there must be more than one drug product featured. If only one drug product is featured, regardless of other branding elements, or even direct mention of the product, the piece would be branded.

Thanks for the question @NatBourre

The app itself would be reviewed against the standards of the code. While all functionality of the app should be included in the submission, the manufacturer’s legal department should ensure that all Federal and Provincial requirements pertaining to the collection, usage, storage and distribution of patient data are adhered to.

Hey @rcolbear

Yes, the entirety of the message delivered should meet the standards of code section 1.5E in order to not be subject to PAAB preclearance.