We’d need to review the specifics relating to this case. I suggest submitting the piece in your preferred configuration and discussing your specific situation with your reviewer.
We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.
We have a situation where previously-approved clinical data in our TMA has been removed. This was an editorial request from Health Canada, simply to make room for new content (as Health Canada often requests trade-offs in order to keep TMAs succinct). It does not reflect a change in approval of the data itself. Therefore, can you advise if this previously-approved TMA data can continue to be used in APS? Note, the data does not appear in published studies and is therefore considered Data on File.
We’d need to review the specifics relating to this case. I suggest submitting the piece in your preferred configuration and discussing your specific situation with your reviewer.
Hi Patrick - Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)?
Hello. The rationale for section 3.7 is that different formulations could cause products to have different properties. One should not assume that two product having different non-medicinal ingredients have identical properties. For example, they may have different pharmacokinetic and / or clinical properties.
Your second question is related to section 3.7 but also touches on other issues in critical appraisal. A clinical trial is an instrument designed to evaluate a hypothesis relating to that particular / precise independent variable. Just as you would not generate claims that extrapolate beyond the studied population, you should not generate claims that extrapolate beyond that independent variable.
We run a website that contain unbranded disease awareness information as well as unbranded drug information. Are we permitted to leverage our website to run targeted ads that link to sponsored DIN-gated sites?
Linkages can alter the regulatory status of the individual elements they link. If I am interpreting your question correctly, it sounds like your targeted ads would inherently brand your disease information.
Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?
No. Clinical trials are conducted to measure efficacy and safety. The described presentation would imply an indirect cross-product comparison of the populations in which efficacy / safety was demonstrated. This would contravene section 5.7 of the PAAB code.
A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too?
If this is an international conference, the material is not created by the Canadian subsidiary, and all other requirements outlined in response to Question #520 are met, this piece would not require PAAB review.
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.
Please refer to the response provided for Question #403. The concept of push vs pull discussed in that response applies here as well.
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.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising