No.
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Hi PAAB, would product related messages posted on the intranet of a company for employees' information be considered direct to consumer advertisement, given that the intranet is accessible to any employee of the company but not to people from the outside? Thank you!
No.
Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!
Internal training materials for your staff does not require PAAB review. It would behoove you to ensure that they are clear on which materials can be shared externally and which cannot. PAAB code section 1.
If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?
Safety information in advertising must reflect the current product label so as not to contravene section 9.1 of the Food and Drugs Act. There is no formal “grace period” per se. It would behoove manufacturers to take action in a manner which demonstrates prompt re-alignment of advertising to the TMA. Patient safety is paramount. PAAB 3.1 & 2.4 & 3.5.
What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?
The manufacturer is required to assess whether the monograph change impacts the piece in any way. If so, the piece should be promptly updated and submitted to the PAAB for review. If not, no action is required. If unsure, submit a written opinion to the PAAB (see fee schedule on our website).
As stated in Q&A # 337, all product advertising is required to be consistent with the Terms of Market Authorization (TMA) per Food and Drugs Act section 9.1 and PAAB code section 3.1. If the TMA changes such that the advertisement is no longer consistent with it, then the manufacturer must update the advertisement promptly. It is possible for the provided preclearance period to be rendered invalid by factors including TMA updates and market place changes. Please call the PAAB office if you want to discuss your specific situation.
In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?
Yes if by alignment you mean same population type, same endpoint, similar magnitude of effect as the data presented in the APS. Note that the data should be presented with the patient case rather than elsewhere. PAAB 3.1.1.
Is it acceptable to use Data on File such as a PSUR to support non-clinical statements such as patient exposure? If so, what format should the Data on File take as it is not possible/desirable to provide the whole document as data on file. Thank you.
Non-comparative claims relating to number of patients who’ve taken your brand OR the cumulative number of years of use across all patients using your brand can be supported with an attestation letter from the manufacturer’s medical/regulatory department. If you have something else in mind, I suggest submitting a written opinion (see fee schedule on our website) which includes the relevant parts of the Periodic Safety Update Report and the precise claim you’d like to use that data to support.
Per PAAB code s3.3, references cited in the APS must be available to health professionals on request, in English and/or French, either in their original form or translated. A copy of the summary of the Data on File must be provided to health professionals upon request.
Is it possible to refer to CME content on a web site in an unbranded email to HCPs?
Yes, if you are not linking CME to promotional messages about a drug.
Is it possible to link a site with CME content from a gated, branded website? If so, is it possible to identify the tab as leading to CME content? Would it be possible to link to a CME-containing site using an interstitial page/disclaimer between this site and a branded website?
You should not link promotional messages to CME because it makes all content promotional and you cannot promote off-label if there are off- label messages in the CME content. Disclaimers don't lessen the intent of linking promotional content to CME.
According to section 7.4, it sounds like Canadian corporate websites need to be reviewed by PAAB. However, I have not come across any that have the PAAB logo. Can you please clarify? From a previous Q&A it sounds like corporate websites have to be written with consumer regulations in mind too since they are publicly accessible. I guess that means we cannot have a write up on the therapeutic areas on the corporate website because that would be linking the therapeutic area to the product, because the product info would be found in the Product Monographs that are linked to the site. Can you please clarify this for me? Thank you!
S7.4 covers corporate websites that contain product information. You can state your products and a separate list of therapeutic areas covered by those products. You should not match the products and the therapeutic use directly. If the website is ungrateful or open to the public you have to comply with federal regulations.
Is it a requirement to include the wording 'For illustrative purposes only' when using videos that depict mode of action, simulate clinical scenarios or pathophysiological pathways?
Mode of action, clinical scenarios and pathophysiologic pathways shown in promotional videos should be supported directly by the product monograph. Therefore, you do not need a statement 'for illustrative purposes only'.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising