347
Is the message "Now Approved" acceptable in APS? It seemed that at one time, this was discouraged due to the perception of Health Canada endorsement
-
Voir réponse [+]
You are correct. It is generally not accepted as it suggests Health Canada endorsement. This is an application of section C.01.007 of the Food and Drug Regulations which was requested by Health Canada. I said "generally" because there are two exceptions which readily come to mind. On occasion, the wording "approved" appears within a product's Terms of Market Authorization (TMA). In those instances, we accept the message with the same context & emphasis as the TMA. "Approved" / "Approval" can also be considered when its context is limited to formulary coverage.
346
Hello. Could you please clarify if the indication statement is considered a claim?
-
Voir réponse [+]
An indication statement is a claim. BUT it does not (in and of itself) impact whether the highest, middle, or lowest level of fair balance is required. A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".
345
In light of the new Fair Balance requirements (high level), are we required to include all the laboratory monitoring as part of the warnings and precautions section? It seems like a lot of info given that they are monitoring guidance but not warnings per se (e.g. monitor leucocytes very 4 weeks ...). Please advise.
-
Voir réponse [+]
The short answer is "Yes". But I think the following details will help you manage the amount of information. Only content referring to monitoring instructions which do not refer specifically to a risk already stated elsewhere in the fair balance need be included. For example, if there is already a bullet referring to risk of reduction of white blood cells, there is no need to also include an instruction to monitor white blood cells. Also note that when it comes to 'Other Relevant Warnings and Precautions' (which is the heading under which this type of info would typically need to be presented if not emphasized in the TMA), you are only required to identify the issue (in this case, the need to monitor X, Y, and Z). There is no need to describe the frequency of monitoring, the thresholds that should trigger further actions...etc.
344
Hi Patrick,
Lately PAAB has been requesting that the indication for a product be placed on the front page of every piece. If we are not making any clinical claims on a front page of a piece, why can we not include the indication on the second page of a piece? Your PAAB code clearly says:
2.10.2 - PAAB code, The TMA content, "Drug X is indicated for" (or equivalent) must be presented verbatim at least once within the advertising message of the APS.
Nowhere does it say it has to be on the front page.....thanks!
-
Voir réponse [+]
Section 2.10.1 states that this information "must be presented prominently among or prior to the first set of marketing benefit claims". Per the definition section of the PAAB code (section 11) such claim can be therapeutic or non therapeutic. The front page often (although not always) contains a claim of marketing benefit. The underlying principle is that the segment of patients for whom the product is authorized should set the context for the corresponding benefits. Also refer to the guidance document "Guidance on Indication Placement in Advertising" on the PAAB website.
343
We are planning market research with healthcare professionals to identify new marketing insights and opportunities. The research will be in the form of informal interviews/discussions with HCPs. Does the PAAB need to be involved with the research planning? This would be organized and conducted by an agency and the sponsoring client would only receive anonymous insights and findings.
Does the answer depend on any of the following?
- If interview questions are provided to the HCP in advance vs. an impromptu discussion?
- If the interview/discussion covers specific products vs. only diseases.
-
Voir réponse [+]
PAAB review of market research activities is not required. The activity itself should not be geared toward promotion of a product. Make sure you are following the Rx&D code with respect to the research activity. You mentioned that your aim is to use the findings simply to help guide future strategic marketing decisions (i.e. internal uses). PAAB comes into the picture if you decide to use the findings as support for messages in drug advertising. In those cases, manufacturers/agencies sometimes submit a written opinion request (see PAAB website for fee schedule) to gain insight into whether the planned research type/method would be appropriate for the intended future advertising objectives. Also note that PAAB review is required if you intend to feed the results back to the participants.
342
In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?
-
Voir réponse [+]
The indication statement must be presented verbatim once in the APS per section 2.10 of the PAAB code. The other segments mentioned in your question need not be verbatim but they must reflect the essence of the product monograph. Please refer to the guidance documents on the PAAB website for requirements relating to fair balance format in drug advertising.
341
If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review?
Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.
-
Voir réponse [+]
If the scenario outlined in your question occurs, the first course of action is to discuss the issue with the reviewer of record. After that discussion, you have an option to contact my Deputy Commissioner Patrick Massad to discuss whether the perceived inconsistency is an actual inconsistency and how to move forward. This allows you to get to a resolution more quickly, and it helps PAAB to address consistency issues. The PAAB reviewers write around 20,000 letters per year and historically real inconsistencies are few. The PAAB struck an industry member committee to investigate consistency during the review process and found that the PAAB has a systematic process to address inconsistency. The board will decide if an audit recommendation will be approved. Thanks, Ray.
340
Can a fractional advertising insert (on light cardboard stock) be
- inserted
- loose with a medical journal that is polybagged
- or glued on the f.p.
size : 2 1/2"x 10" or 4" x 10"
printed on both sides
insert to be glued on the f.p.
-
Voir réponse [+]
In principal, these executions are possible. But keep in mind that each piece would be reviewed as a separate ad unit which is required to meet the fair balance requirements. Plan the piece with those fair balance requirements in mind. I invite you to refer to the guidance documents on the PAAB website to determine which level of fair a balance needs to appear with your intended claims and ensure that you design the piece such that it accommodates prominent presentation of this content within the main advertising message.
339
If we believe content is PAAB exempt, due to new guidelines, do you need to review the content and how it will be used to determine PAAB exemption and then send us a letter stating exemption or not?
-
Voir réponse [+]
There is no requirement to submit pieces which fall within the realm of exempt advertising per PAAB code section 6.6 or non-advertising per the Health Canada policy document "The Distinction Between Advertising and Other Activities". If you are uncertain about whether the piece requires review, feel free to use our written opinion service. See the fee schedule on our website
338
Can you advise if published, qualitative studies are acceptable for patient preference claims under the new Code?
-
Voir réponse [+]
I presume you are asking whether it is acceptable to use a survey to assess patient preferences. If I am far off of your intended meaning give me a call.
The code change had no impact on this topic. As per before the code change, we can consider this type of presentstion when the survey was conducted by a third party receiving unrestricted funding from the sponsor (e.g. sponsor had no influence on the design, the selection of participants, creation of the survey instrument, implementation of the survey, and the analysis of the results). Preference claims must be based on statistically significant results and limited to non-therapeutic aspects of treatment (e.g. "preferred the taste of... " or "preffered the nozzle length of..."). Open claims of "preferred drug X" (i.e. without explicit limitation to non-therapeutic aspects) are not accepted from surveys. Claims of "preferred the efficacy [or safety] of..." are also not accepted based on surveys. Again, call me of this is
not what you were looking for.
