Yes it still applies. Secondary endpoints should not be used from a failed study.
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The Guidance document 'Claims Based on Non-Inferiority Trials' states that "In the event the non-inferiority study failed to demonstrate superiority in the primary endpoint, one should not use secondary endpoints to suggest superiority." Does this still apply if the primary/secondary endpoints are unrelated (eg. primary endpoint is an efficacy measure, secondary endpoints are safety measures)?
Yes it still applies. Secondary endpoints should not be used from a failed study.
Hello. Can a pharmaceutical company post a tweet on its Twitter platform about its product winning a research/innovation prize? For example, "Congratulations to Product X for winning the 2017 YZ Prize!"
Assuming that this is a prescription product, PAAB would advise against this for a couple of reasons:
If we pay for a beauty expert to talk about one of our OTC products live on a tv show like Breakfast Television (on City TV), should the beauty expert mention live on the show that they are being paid by a pharmaceutical company?
OTC advertising which is broadcasted to the general public does not fall within the scope of the PAAB. Nonetheless, we direct you to the updated Canadian Code of Advertising Standards available at http://adstandards.com/en/Standards/canCodeOfAdStandards.pdf where you’ll find that interpretation guideline #5 (page 13) addresses your precise question.
Does a HCP-directed website for a Schedule D vaccine need to be gated?
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?
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 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!
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!
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:
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.
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).
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.