Please refer to the response provided for Question #403. The concept of push vs pull discussed in that response applies here as well.
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Would materials used to train Healthcare professionals prior to using a product be items to be reviewed by PAAB, or do they reflect more Continuing education materials? The trainings would be done on site by medical science liaisons.
It seems that materials that cite a product is available through the Special Access Program would be considered promotional. Are these types of materials reviewed and approved by PAAB, or are they strictly prohibited as alluded to in the Health Canada Guidance regarding special access programs? Without some notice, I don’t know how healthcare professionals know whether a product is available through SAP.
Please refer to the Health Canada Document “Guidance Document for Industry and Practitioners – Special Access Programs for Drugs” available at the following link:
Section 7 deals specifically with advertising. The document states that “In accordance with section 3 of the Food and Drugs Act and section C.08.002 of the Food and Drug Regulations, advertising of unauthorized drugs accessed through the SAP is strictly prohibited”. Practitioners interested in the status of a particular drug may contact the SAP directly.
I have seen mixed messages as to whether PAAB review of prescription pharmaceutical advertising must be reviewed by PAAB. Can you confirm or refute that PAAB review is required?
PAAB review is mandatory for industry generated opioids materials directed to or through healthcare professionals (e.g. advertising, risk management tools, patient information). It is voluntary for other healthcare professional and patient materials.
For all other drug advertising, PAAB preclearance is recommended by Health Canada and is supported by the major pharmaceutical industry trade associations. In fact, for some pharmaceutical trade associations, PAAB preclearance of advertising is a condition of membership.
If companies choose not to come to the PAAB and the PAAB receives complaints about their advertising or we find code infractions through our monitoring activities, the PAAB will ask Health Canada to intervene. The PAAB has increased its own proactive monitoring activities this year. Additionally, we collaborate with Health Canada’s new proactive monitoring initiatives.
The PAAB endeavours to make the unique Canadian healthcare product advertising self-regulation system work for all companies in the best interest of Canadian patients.
If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?
See PAAB code section 7.4. Based on the information in the question, the answer is no. But please note that the piece still requires PAAB review (dues to the product list).
We will be offering OTC product samples through a third party sampling program. In the order brochure there will be a pack shot of the sample pack, brand name and dosing. Does this need to be PAAB approved?
Assuming they are directed to HCPs, yes.
We have a non-prescription drug and we plan to leave coupons for patients in the doctors' offices. Do the coupons need to be PAAB approved?
Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required?
For non-prescription products, we have considered the claim based on robustly designed surveys published in healthcare professional journals. We have not accepted the claim for prescription products. For prescription products, the answer is no. Claims relating to recommendations should emanate from Canadian consensus guidelines (i.e. these inform the extent to which a product is recommended), and guidelines don’t tend to structure their recommendations in this manner.
Additionally, for prescription products, Rx data (e.g. supporting “#1 dispensed”) captures a much larger number of datapoints than survey data, which often requires extrapolation from smaller samples to much larger populations. I suggest going the “#1 dispensed route” instead.
We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation, which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?
I can only speak in general terms as I don't know the particulars of your specific case. In general, Canadian guidelines can be used to support place in therapy recommendations that are aligned with the product's TMA. However, the basis for the recommendation tends to touch on topics such as comparative efficacy, safety, tolerability, adherence, cost-effectiveness, and so on. Guidelines are not an acceptable evidentiary basis for claims pertaining to these parameters. Please refer to the following document highlighting the evidentiary requirements for different types of messages in advertising:
There are several differences between consensus guidelines and a detail aid. Arguably the most germane to your question is that consensus guidelines are created independently of the manufacturer and are therefore exempt from PAAB preclearance (provided that it is the complete and unedited document). The detailing aid is advertising which is subject to advertising regulations. You can also refer to the section "Reference texts, Peer-reviewed Journal Articles" in the Health Canada Policy Document "The Distinction Between Advertising and Other Activities.
In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated in the xxx development program." Please advice if my assumption is correct. Thank you.
A definitive answer cannot be provided without consideration of the complete TMA in the context of the relevant area. There are times when the absence of information is an important factor in rational product selection. For example, disclosure of this absence of information is more important when there is reason to believe that the product may cause motor or cognitive impairment (e.g. say the pharmacodynamics section of the PM speaks to molecular interactions with a receptor implicated with motor or cognitive impairment, or say the product shares the same mechanism as other products in it's pharmacologic class known to cause motor and cognitive impairment). On the other hand, there's little reason to require inclusion in fair balance if the topic is included in the TMA merely for consistency with the standard monograph template.
Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner?
I assume you are asking whether you can support a statement like X% of patients with condition Y have characteristic Z. Patient support program enrollment data would not meet the standard level requirements for epidemiological statements about the disease (e.g. demographics). A published and peer-reviewed epidemiological study which is relevant to the Canadian market could be considered as could an authoritative source such as Canadian guidelines.
Another important consideration, in addition to the evidentiary issue, is whether discussion of that particular sub-population would be acceptable in the branded piece (e.g. is the subpopulation discussed in the TMA?)
Cocktails: 5:30 p.m.
Dinner: 6:00 p.m.
Panel Discussion: 6:30 p.m.