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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.

Most Recent Questions and Answers
508

If exacerbation rates are provided in a publication with other details with which NNTs can be calculated, would PAAB allow us to promote the NNTs?

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507

The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?

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506

Hi! Do corporate branded educational tools (no claims or messaging) need to be reviewed at paab? For example : knee bone joints? Or skeleton etc Thanks!!

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505

Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.

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504

Dear PAAB Can the branding of disease specific information for medical professionals resemble the branding of a product not yet launched? (i.e. Does PAAB place any restrictions on the branding of disease specific information and product APS?)

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503

We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?

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502

Is Pharma allowed to sponsor an independently-developed, physician-managed, online discussion forum? Pharma would have no involvement other than to provide funding for its development. What if the discussion forum is managed by Pharma's communication agency?

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501

The ASC's bulletin in April 2015 indicates that the statement "Product X is authorized for sale by Health Canada" is consistent with the Food and Drug Regulations and acceptable for use. Previous Ask PAAB questions 108 and 347 also address this issue and section C.01.007. We note that Health Canada's Consumer Advertising Guidelines for Marketed Health Products has precluded the use of statements that suggest authorization by Health Canada, and has not been updated since the ASC's bulletin. Can you please provide PAAB's position on the use of the statement above and also whether the use of "approved by Health Canada" or similar statements is acceptable?

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500

Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?

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499

We are experienced in submitting DTCI campaigns through regulatory. In these cases, the focus is on the disease and when mentioning drugs, we discuss all treatments indicated for that disease (because there cannot be undue emphasis on any one drug). However, we wish to know about the DTCA of vaccines. For example, are we allowed to talk about the indication/side effects/dosing, etc for one vaccine specifically without mentioning the other vaccines indicated for the prevention of the same disease? In this case, it'll have the "undue emphasis" which is not permissible for schedule F drugs.

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
Upcoming meeting

February 27, 2018

PMPRB Changes; Industry Outlook and Impact – What you should know

Welcome & breakfast: 7:00 a.m.
Conference: 7:30 sharp - 9:00 a.m.

Click here to register