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In summary, all regulations prohibit advertisement to the general public, but the definition of general public excludes patients.

Username

Hoping to receive a clarification per @Constance 's question!

QnC

Given the following regulations and definitions, why can't patient-directed APS for prescription/controlled/targeted drugs be promotional?

FDA Section 3(1): No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

FDR Section A.01.067: A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

FDR Section C.01.044: If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.

CDSA Section G.01.007: No person shall
a. advertise a controlled drug to the general public or
b. issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement

Benzo Regs Section 78: A person must not:
a. advertise a targeted substance to the general public or
b. issue or publish an advertisement for a targeted substance unless the advertisement:
i. is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals and
ii. displays in the upper left quarter of its first page, in a clear manner and in a conspicuous colour and size, the following symbol:

And definitions from Guidance on distinction between advertising and other activities for health products:

Patient: An individual who has a medical condition and is receiving, or is registered to receive, care.

General public: Ordinary people, especially all the people who are not members of a particular medical, pharmaceutical or scientific organization or who do not have any special type of medical or scientific knowledge. This excludes persons who have been prescribed a health product by a health care professional (HCP).

Jennifer Carroll

Hello @ebailey

A search of the term "company" on the forum will return Q&A 744 which should answer the above question.

Jennifer Carroll

Hello @Maha-Dogar

Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.

Jennifer Carroll

Hey @kshulist

This question reads as tactic- and copy-specific and therefore would not be considered a general question. A general question would be something along the lines of: “In general, how should consensus guideline recommendations that apply to multiple products within a therapeutic class be handled when referenced in branded promotional materials?”

In response to such a general question, we would direct you to What Constitutes Current Medical Opinion?. Canadian guidelines may be used to support place-in-therapy claims relating to the sponsor’s product.

It is important to note that where guidelines reference a therapeutic class without specifically naming the sponsor’s product, presenting class-level claims in a branded context may be considered misleading. In scenarios where the sponsor’s product is not explicitly reflected in the guideline recommendations, we recommend discussing the proposed approach with your PAAB reviewer to explore potential options that could meet your objectives while ensuring the guidelines are represented accurately and in context.

ebailey

I am working with a company that will be changing their legal name in Canada this month. This will require an update to the legal portion and logos on their marketing materials.

For pieces that expire later this year, does PAAB require they be updated within a certain time period? Do these need to be submitted or can we send them to PAAB as an FYI (assuming no content changes beyond the company logo and legal line)?

One of the materials also expires this month, but we will most likely not have the logos in time for the renewal. Are we okay to submit and update the logos as an FYI once they are created? Or are we better off to ask for an extension?

kshulist

Hi there,
I was wondering if it was possible to present the consensus guidelines' recommendations for all products in a certain class in a branded sense?

For example, DrugA, DrugB and DrugC are all the same class with the same indication in diseaseX. They are the only drugs in that class. Could we have a branded APS for DrugA where we neutrally present the recommendations for DrugsA-C in diseaseX (not necessarily verbatim, but accurately and within context without imparting new/different meaning than the guidelines)? If it helps, it would be a piece focused on the recommendations with no other data/claims about DrugA (but still containing the indication).

I've seen this done in an unbranded piece, but was wondering if it could be done in a branded piece as well.

Thank you!

Jennifer Carroll

Hey @Maryssa

The initial question related to self-directed digital advertising on an HCP website. The Q&A 199 language you referenced applies specifically to rep-directed materials and should not be relied upon for self-directed digital ads.

For self-directed digital ads, we suggest reviewing the principles presented in guidance on fair balance and web-link destination examples (search “study parameters”).

Required study parameters may be presented either within the same ad unit (including in a clearly labelled scrollable section immediately below the ad) or via a direct web-link destination, provided that:
• it is clear on the face of the ad where the study design is located,
• it is clear how to access the study design
• access does not require additional effort beyond a single click or scrolling (i.e. the content is accessed without any barriers)
Please note that where specific elements from the study parameters are required on the face of the ad (e.g., dose), those elements would not be acceptable solely as a web-link destination or scrollable section.

Maryssa

Thank you for directing me to these helpful discussions!

As a follow-up question, could we put the study design footer (and other required footers) into a scrollable section of a digital ad that appears right below ?

"Study parameters may be presented as pop-ups which appear once the drug representative clicks on the claim or performs a mouse-over" in Q&A 199 seems to imply that study design footers can be placed elsewhere but I am hoping you can provide more clarity.

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