Demandez au CCPP

Does a HCP-directed website for a Schedule D vaccine need to be gated?

• Voir réponse [+]

  ---

  The fact that the vaccine (Schedule D) website is intended for HCP’s does not, in and of itself, trigger the requirement for gating (BUT it does trigger the requirement for PAAB preclearance). The piece would require review under the PAAB code for HCP advertising with the consumer as a secondary audience. In addition to being clear that HCP’s are the intended audience, this also means that it would also be reviewed under the Health Canada Therapeutic Comparative Advertising: Directive and Guidance document and the Policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products. Some changes may be required to the HCP messaging to address the consumer regulations. One example would be that therapeutic claims in the consumer realm require the support of two separate RCTs. This will likely mean the removal of the therapeutic comparisons in the piece (even if they were previously approved in HCP advertising). The alternative, of course, would be to add a gate.   

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.
When we move ahead with this how do we not conflict with publishing certain types of diseases we're targeting with names of products and to announce we have found a way to replace current immunization programs without getting the ire of the scientific community?

How do we announce this on TV when the large pharmaceutical companies control them?

• Voir réponse [+]

  ---

  Incorporated in 1976, the Pharmaceutical Advertising Advisory Board (PAAB) is a not-for profit, self-financing organization funded entirely by the fees paid by advertisers for preclearance review (not for the acceptance). The highly trained PAAB staff runs the preclearance program to ensure that proposed advertising meets Code standards for the promotion of pharmaceutical products. The PAAB code can be found on the website at www.paab.ca

  The code was created (and is maintained on an ongoing basis) by the PAAB Board of Directors. The following organizations are members of the PAAB and have appointed official representatives to its Board:

  • The Association of Faculties of Medicine of Canada
  • Association of Medical Advertising Agencies
  • BioteCanada
  • Canadian Association of Medical Publishers
  • Canadian Generic Pharmaceutical Association
  • Canadian Medical Association
  • Canadian Pharmacists Association
  • Best Medicines Coalition
  • Consumer Health Products Canada
  • Innovative Medicines Canada
  • CARP
  • Consumer Council of Canada
  • Fédération des médecins omnipraticiens du Québec

  The PAAB mission is to deliver pre-clearance review services that support trustworthy health product communications that comply with the Canadian regulatory framework. The PAAB's primary role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate.

  The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB's Scope evolves with the regulatory framework.

  Please visit our website at www.paab.ca for more information and don't hesitate to call us at (905) 509-2275 if you have any questions. Also find us on LinkedIn, join the PAAB group and participate in the discussion!

Hi, We are a health clinic interested in running a publicly funded flu shot campaign for the public. We want have free coffee cards and lollipops to give to anyone who comes in and gets a flu shot. Are we allowed to advertise in a flyer and emails to the neighbourhood businesses specifying that anyone who comes in and gets a flu shot will get a lollipop ad free coffee cards? What are the regulations surrounding advertising our flu shot clinic? Thanks!

• Voir réponse [+]

  ---

  The activity described is not within the PAAB mandate or scope. This flyer is not directly promoting a product (i.e. a specific vaccine) but is advertising a clinic and the activities surrounding it. You may wish to consult with your local public health unit.

What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and signed, and would like to email this Enrollment Form to HCPs directly via the reps. Could you please inform me if this contravenes any PAAB regulation? I was unable to find anything in the PAAB code that would suggest this. Thank you!

• Voir réponse [+]

  ---

  PAAB approved print APS which are reformatted onto an electronic platform for further distribution by the sponsor require the PAAB review of the electronic format unless all of the following criteria are met:

  • The PAAB approved APS is still within its approval period
  • There have been no product monograph updates (or Health Canada warning letters) since approval of the original piece
  • The same content/layout/flow is maintained as in the approved print APS. For example:
    • Any size changes are directly proportional throughout the APS
    • Content on the page are not repositioned to optimize for landscape/portrait mode
    • No new functionality is added other than zoom-in and zoom-out. e.g. if scrolling functionality is added selectively to portions of a piece, the PAAB review is required to ensure it does not cause the Fair Balance prominence to become insufficient i.e.. the piece on the electronic platform would essentially be comprised of all scanned pages in same order as the print APS
  • The APS context (e.g. branded vs unbranded) and the target audience are unchanged

  In the scenario described above, the electronic piece which is now being distributed via email may have additional considerations such as the subject line, email body copy, and potential linkages (i.e. websites, other APS, etc.) within the piece which would require PAAB review. Once approved, distribution directly from reps to the healthcare professional would be acceptable. 

Hi, We were thinking of providing our reps with iPad covers that have images from a campaign that we intend to launch. The iPad covers will be solely for the reps and won't have any sort of messaging on them, but will have the names of our brands. Do we need to put the covers through PAAB? Thanks.

• Voir réponse [+]

  ---

  As the iPad cover may be visible to the healthcare professional during rep calls, it falls under the PAAB scope of review. The question then becomes, is the content on the iPad cover exempt from PAAB review. Please refer to section 6.6 of the PAAB code for a list of exempt claims. We caution that images may convey messages which change the status of the piece such that it requires PAAB review. If you are unsure if your piece is exempt from review please submit to PAAB for an opinion (see the fee schedule on our website).

• Voir réponse [+]

  ---

  Please see Q&A 476.

• Voir réponse [+]

  ---

  For the benefit of the other readers, I presume you are referring to Q&A 512. A drug’s MOA is an objective and intrinsic pharmacological property of the drug. It requires more than a couple of in vitro studies and/or review papers to support it. Generally, such claims are required to be supported by the TMA as discussed in the following PAAB tip document: https://secure1.paab.ca/Marketing_Benefit_Claims_-_June_22.pdf

  Sources like authoritative consensus guidelines or medical textbooks can be used to support pharmacologic classification. Additionally, they may be considered to elaborate on the existing mechanisms in the TMA where there is ample alignment among various medical texts and guidelines, but a detailed presentation of the MOA from those sources would conflict with a product monograph which states that the “the exact mechanism of action is unknown”. Thus in cases like Q&A 512, the TMA would generally require updating prior to consideration of a more elaborate MOA presentation.

• Voir réponse [+]

  ---

  I’ll begin by paraphrasing s3.1.1 in saying that pooled analysis are generally not considered high-level evidence. Now, onto your question. There is a difference in the sense that, post-hoc, I may select which studies to include/exclude in a pooled analysis based on how each potential combination will impact the outcome. Pre-specifying the pooling protocol & studies eliminates that risk. But there is more to this than the simple fact that pre-specifying commits me to the studies I’ll eventually be pooling. Pre-specifying may also enable me to consider my intention to eventually pool the data while I am designing those individual studies. This way, I am more likely to design the studies such that the endpoints are defined & measured the same way, the drugs are dosed the same way, identical inclusion/exclusion criteria are used… etc. These all impact the validity of the pooled analysis. I should stress that this is not always the case. I’ve seen pre-specified analysis where important aspects of the methodologies conflicted (thus calling into question the pooling). Also, note that a pooled analysis cannot be considered if the individual studies do not meet the rigors of the PAAB Code and guidances. It is also important to note that a pooled analysis cannot be used to convey an outcome which differs from individual trials in the TMA (i.e. advertising must be consistent with the TMA). As you can see, there is a lot to consider here and it’s impossible to capture it all in a general answer to a general question. For an answer more specific to your situation, you’ll need to submit a written (see fee schedule on our site).

• Voir réponse [+]

  ---

  Many variables impact the specific answer to your situation. A couple of key considerations, for example, are whether the individual studies meet the rigors required by the PAAB code/guidances and whether the results of the individual study you want to present is in alignment with pooled outcome in the product monograph. Although pooled data is not generally regarded as being high-level of evidence, advertising must be consistent with the Terms of Market Authorization (i.e. product monograph) and certainly cannot contradict it. For an answer more specific to your situation, you’ll need to submit a written (see fee schedule on our site).

Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).

• Voir réponse [+]

  ---

  Please note that in Question #273 the copy “it may be exempt if all the treatments are balanced” speaks to the references being used to support the piece, not the content within the piece. If a drug manufacturer is generating a piece directed to healthcare professionals, which discusses drug products, PAAB preclearance is required regardless of the degree of balance.