Yes. Please ensure you follow the guidance for Help Seeking ads in the Health Canada policy document "The Distinction Between Advertising and Other Activities". There should be absolutely no implication that a drug is the sole treatment available.
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Is it allowed to do "help seeking announcements" if you are the only prescription product with a specific indication. We would not reference treatments, just talk to your doctor about diagnosis. Thank you for your help.
Yes. Please ensure you follow the guidance for Help Seeking ads in the Health Canada policy document "The Distinction Between Advertising and Other Activities". There should be absolutely no implication that a drug is the sole treatment available.
Can a television spot that has run in the United States run in Canada if it has been stripped of all branding and promotional claims, and edited to meet the requirements of a help-seeking ad?
I’ll presume from the question that this relates to a prescription product. Canadian’s may have seen the U.S. branded ad. Canadians could therefore link the unbranded Canadian ad to the branded U.S. ad if it has a similar look and feel. This linkage could contravene the section C.01.044 of the Food and Drug Regulations. This might also be difficult to defend from an ethical perspective.
We suggest creating an entirely different unbranded ad. Alternatively, you could consider running a Canadian branded ad (rather than a help seeking message) with the same look/feel as the branded U.S. ad BUT limited to name, price and quantity.
We are developing an unbranded APS (Journal Ad). This APS would contain statistics and data pertaining to disease state. This APS would be disseminated directly to HCPs via print publications and perhaps some e-publications. The call-to-action on the APS would lead HCPs to register for an accredited e-CME on the disease state. Will PAAB require that the accredited CME be submitted for review?
No. But there is an important caution to consider as you mentioned that there will be a focus on discussion relating to the disease (rather than simply a corporate piece inviting HCPs to register). Accredited CME may be linked neither to branded advertising nor to unbranded advertising (aka editorial advertising). This is important because linkage of CME content to advertising of any sort risks rendering the CME content subject to the advertising regulations EVEN IF IT IS ACCREDITED. This would be problematic as the CME likely includes information which is off-label. You’ll therefore want to make sure that the journal ad does not fall in the realm of advertising. I suggest you submit the journal ad to PAAB for a written opinion to ensure that this is the case. Some obvious things to avoid include mentioning any medicinal product/class, and/or discussing a drug issue in the invite. As there are other more subtle ways to cause the invite content to fall in the advertising realm, particularly in the way the disease is discussed, I’ll reiterate the invitation (not requirement) to submit for a PAAB opinion.
IMPORTANT NOTE: Should the journal ad relate to pharmacologic class areas in which the manufacturer has a vested interest, PAAB review would be required under PAAB code section 7.5. Of course, the PAAB would not accept the link to accredited CME for the reason described above (i.e. editorial advertising linked to CME would cause the CME to be subject to the advertising regulations).
For traditional online banner ads, how can one be expected to fit the verbatim indication on the first 'frame' also containing a claim? Traditional banners are only a few pixels in size, which seems to prohibit effective advertising for products with larger indications.
You are referring to the PAAB code 2.10 which requires that the segment of patients for whom the product is authorized sets the context for the promoted benefits. Code 2.10.1 clarifies that this info must be presented with or “prior to the first set of marketing benefit claims”. This requirement applies regardless of the media. Advertisers have made their banners work within the regulatory requirements in several different ways. For example, some have elected to include only the indication on frame 1 (and start the claims of benefit on frame 2 or later). Others have elected to convert their claim of benefit into a claim neutral question. For example, rather than stating "Drug X is the most dispensed…" in frame 1, they’d simply ask "Which drug is the most dispensed…?" without identifying the product on the frame (e.g. no product logo). Frame 2 would then include the drug name and indication. There are several other ways to make this work. The key to all solutions is the ability to automatically rotate between frames. If this is not possible on the site in question and the banner space is very small, this is simply not an appropriate environment to include advertising claims. In such cases, consider a name only ad or an ad containing only a message exempt from PAAB preclearance.
As your question mention’s the word "verbatim", I feel that I should clarify that section 2.10.2 states that the TMA content “Drug X is indicated for” (or equivalent) must be presented verbatim at least once within the advertising message of the APS. Don’t confuse "at least once within the advertising message" with "among or prior to the first set of marketing benefit claims".
Are medical devices specifically excluded somewhere in the PAAB Code of Advertising Acceptance book?
Yes. See the "Healthcare Products" definition in PAAB code section 11. This exemption applies to class I, II, III, IV medical devices.
With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions "treatment" without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait.
"Class" refers to pharmacological classification (e.g. ACEI, Beta-Blocker, Calcium Channel Blocker). "Category" refers to a higher level in the hierarchy (e.g. "antihypertensive treatment", "blood pressure meds", "drug treatment for blood pressure". I say "higher level" simply in the sense that there can be more than one class in a category.
You’ve touched on an interesting property relating to the term "treatment". Although it often refers to drug treatment (especially in the context of APS generated by pharmaceutical companies), it is possible that it refers solely to lifestyle adjustments, medical devices…etc (i.e. completely exclusive of drug therapy). Context is important in cutting through that ambiguity. Generally, the executions I’ve seen don’t stop at the fact that management includes watch and wait. They usually go on to say "…and drugs… to help reduce the risks of heart attacks and death and help improve quality of life". That may or may not be an infraction for the therapeutic area at hand. That’s why the content would be reviewable under section 7.5 of the PAAB code (i.e. so you can find out and adjust accordingly as needed). The point is to ensure that the manner in which medications (even on the conceptual level) are represented vis-à-vis the disease is accurate, balanced, and evidence based.
Hello, in case of branded APS, are references older than 10 years not accepted? Thanks!
It is possible for an old reference to be questioned, but this is not necessarily the case. PAAB has rejected references which are less than 10 years old and PAAB has accepted references which are more than 10 years old. There is no single magical cut-off period. This is because it is NOT simply a matter of how long ago the reference was published. Rather, it is a matter of whether there are reasonable grounds to presume that the reference is still reflective of the present state of affairs. Passage of time is a factor in so far as circumstances which determine/influence the state of affairs change over time. For example: medical practice evolves, new products come to market, public policy shifts, health promotion practices change, the epidemiology of conditions change...etc.
It is true that the more time elapses the more opportunity for factors to impact the applicability of the older data to today's reality; however, some issues are much more dynamic than others. In fact, there are very old references which still reflect (or likely reflect) the present state of affairs. There are also very recent publications which deal with topics which are so dynamic that they are already out of date (e.g. incidence of antibiotic resistance for an antibiotic).
One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?
No. An APS presentation conveying how the sponsor’s drug compares to a reference comparator would not meet the evidentiary requirements of the PAAB code (i.e. a rigorously designed study with pre-planned inferential statistical significance analysis directly comparing the two active products). Note however that the RC data could be considered in cases where the PM contains the RC data (rather than the only mention of the RC being in the study description). In such cases, the data presentation should reflect the context and emphasis of the product monograph.
Does an advertisement for an OTC product that will run in a medical journal require PAAB approval? The ad does include product claims, with references.
Yes. Section 1 (Scope) of the PAAB Code of Advertising Acceptance includes the review of advertising of non-prescription products directed to health care professionals.
If I have an APS which is left behind, however only contains the name of the product with no other information (i.e., company name, price, quantity, indication etc.), do I need PAAB’s approval?
If the piece has nothing on it other than the drug name and it is linked to no other materials (e.g. it distributed alone rather than with other pieces), it is exempt from preclearance. Refer to PAAB code 6.6.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising