DTCA/I | consumer secondary audience

773

If an independent third party (e.g. patient advocacy group) runs a DTCA campaign, would it need to comply with DTC regulations even if they are not the sponsor or manufacturer of the drug? Yes. An advertising campaign directed to consumers must comply with the DTC regulations regardless of if it is produced by an independent […]

771

Dear PAAB reviewers, I have a question regarding the “Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context” guidance – several of our clients have pulled back on rep visits to HCPs in-person in light of COVID and have asked us how they can disseminate DTC waiting room […]

770

I am new to the world of PAAB and I am wondering what the code allows in terms of non-product branded advertising on social media, targeted to HCPs. For example, videos of HCPs speaking about a disease and how it’s important to treat/vaccinate against, without mention of a specific drug, being shared as sponsored ads […]

612

In the context of a Consumer Brochure, is it permissible to provide DINs for a balanced list of medication options? I’d advise against doing so as DINs tend to be used as the gating mechanism for patient information websites. i.e. promoting the DIN of your products in the consumer realm would likely invalidate the gating […]

614

Is it acceptable to advertise a statement that says something along the lines of: “Drug X is the only drug containing active ingredient Y that is approved from clinical tests?” assuming that this statement is true? Would that change if the statement is more specific, such as “Drug X is the only epidural drug containing […]

615

Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you! If this was a “requirement” stated in the […]

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 […]

610

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)? […]

608

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 […]

603

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 […]

604

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 […]

605

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 […]

593

We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the […]

595

Will PAAB approve MOA comparison around selectivity in an unbranded leave behind – content is not from individual TMAs but from recent post-NOC invitro peer reviewed paper? The description of a product’s MOA must be consistent with and within the limitations of the current Terms of Market Authorization. See Ask PAAB responses to questions 512 […]

596

A disease-state piece includes mention of treatments in a balanced manner. It is distributed to consumers as a Consumer Brochure and technically exempt. Can this same piece be distributed to HCPs, or would it have to be revised to meet Editorial APS requirements? Does the content and/or level of detail dictate this? Distribution of a […]

598

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). […]

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