Miscellaneous

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  COVID-19 Patient Support Program
  • SKW  

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  @SKW If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.
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  Covid-19 Question
  • SKW  

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  Hello @SKW In answer to your question, please note that the same email sent individually to several doctors would not be considered a 1:1 message. The message described above could be considered exempt if it meets the limitations of a corporate message with no product mention (e.g. identifying or alluding to a product name, class, category). See code section 1.5E. We strongly urge that the email copy goes through the manufacturer’s internal compliance channels. If there are any doubts that the message is truly corporate and does not allude to products, it can be submitted to PAAB for an opinion (4 day turnaround).
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  744 - Change in Product Ownership - if Company A divests Product X to Company B, can Company B continue to use promotional material for Product X that was previously approved by PAAB for Company A during the DIN transfer, or only post-DIN transfer? If so, can it be used until the renewal date?
  • Jennifer Carroll  

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  There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?
  • Jeff Kent  

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  @Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?: Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids). However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance. Thanks Jennifer - this is very informative. We will share this with our customers.
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  732 - Is this "Ask PAAB" still active? We have submitted queries 4-weeks ago and did not see any responses? Could you please provide an update?
  • Jennifer Carroll  

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  731 - Is the PAAB logo required to appear on HCP advertising or patient information approved by PAAB.
  • Jennifer Carroll  

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  730 - Hi Patrick, I have a question related to providing PAAB training. I remember few years ago you came to our company and you provided training. There have been many changes since then and I was wondering if you are still providing similar training. What is the cost associated with this type of activity?
  • Jennifer Carroll  

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  728 - Hi Patrick - I've read the 2019 Client Survey report on the PAAB website. Is there a plan to disseminate this more broadly, and what actions is the PAAB taking with regards to any of the specific survey results? Thank you.
  • Jennifer Carroll  

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  717 - How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks.
  • Jennifer Carroll  

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  710 - For Help-Seeking Announcements, the Distinction Between Advertising and Other Activities states "there is no implication that a drug is the sole treatment available". Does this mean no implication for a single brand within the context of available drug treatments, or no implication for drug treatment over non-drug treatment?
  • Jennifer Carroll  

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  700 - Can we present two different brands, (which are two different therapeutic areas) in one APS (i.e. in a LB) as long as the indication and balancing info is presented for both brands?
  • Jennifer Carroll  

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  693 - Is a non-medical device associated with a drug be recognized as a therapeutic product regardless of whether the ad in question contains information about the drug itself in a direct to consumer standpoint?
  • Jennifer Carroll  

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  692 - In DTC would non-medical devices (i.e. Breezhaler/Respimat/Ellipta) be associated with their drugs immediately? As such be limited to the name, price and quantity in terms of messaging or would there be leeway to talk about device features in a comparative standpoint or would that be against the code?
  • Jennifer Carroll  

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  684 - When two companies are co-promoting a product and using the same material approved by PAAB, are the promotional materials required to display both company names and/or logos or can the material have one company name and log and still be used by both companies?
  • Jennifer Carroll  

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  676 - 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)?
  • Jennifer Carroll  

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  659 - As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years". It is our understanding that for any APS we are limited to one year of usage of the word "New" from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product" is referring to?
  • Jennifer Carroll  

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  639 - Just wondering how long it would take to receive a response to a question submitted through Ask PAAB?
  • Jennifer Carroll  

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  635 - For APS having only two surfaces (i.e. a double-sided card), can you confirm if market benefit claims can appear on side 1, with the indication appearing on side 2?
  • Jennifer Carroll  

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  621 - Has the PAAB ever considered providing review comments as annotations on submission documents, rather than an itemized review letter? This would seem to save both PAAB and Clients time.
  • Jennifer Carroll  

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  606 - Hi! We would like to know what the role of PAAB is? Do you support innovation or the pharmaceuticals? This is not meant to be prejudiced in anyway. We've tried to work with pharmaceuticals to put a product that could eventually replace vaccines, replace the current international immunization plans, prevent outbreaks and epidemics.These are just starters. We've conducted full scale animal trials and safety trials and will soon be ready for Phase 1 trials for Universal Flu, HIV/AIDS, Cancer for leukemia and Hodgkin's, all enteric diseases and one to replace the immunization program. I see from PAAB's membership there are a lot of pharmaceutical and vaccine companies represented. We've approached several foundations, vaccine companies and pharmas and got similar "not interested" responses.
  • Jennifer Carroll  

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