Patient info

501

The ASC's bulletin in April 2015 indicates that the statement « Product X is authorized for sale by Health Canada » is consistent with the Food and Drug Regulations and acceptable for use. Previous Ask PAAB questions #108 and #347 also address this issue and section C.01.007. We note that Health Canada's Consumer Advertising Guidelines for Marketed […]

505

Dear PAAB – would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label. Lowest provided the criteria does not include a claim which triggers highest level (e.g. efficacy/safety claim) or middle (e.g. pharmacokinetic claim).

500

Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)? Class I, II, III, and […]

491

Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it […]

492

We will be running a webinar from our HCP website. The webinar will be delivered by an internal medical expert. The webinar content will be on-label and pre-cleared. HCPs will need to register for the webinar on the « events » section of our gated HCP website. This section would only contain a list of upcoming webinar […]

493

Since DTC advertising is not allowed for products that treat or prevent schedule A diseases, I was wondering whether a product that managers a symptom of a schedule A disease (example: hypoglycemic reactions in diabetes) would have the same restriction? Yes. See section 2.3.2 here: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/scha_guide_ld-eng.php “Many Schedule A diseases are closely associated with symptoms […]

494

On a STI sample card the Brand name is included along with images of the product. Does this need to be PAAB approved or is it exempt (i.e. no claims are included, no indication statement just product name). Thanks The card itself can be exempt (even though it contains the Brand name) if it contains […]

495

If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products? Yes. As long as you can be clear which statements/risks […]

496

Hi, would a product announcement with: the name of the product, « now available in Canada », and package shot (with no visible therapeutic claims) be considered paab exempt? if the product came in multiple pill sizes, can a shot of the pills with their sizes be allowable as the product shot? Not sure I understand so […]

499

We are experienced in submitting DTCI campaigns through regulatory. In these cases, the focus is on the disease and when mentioning drugs, we discuss all treatments indicated for that disease (because there cannot be undue emphasis on any one drug). However, we wish to know about the DTCA of vaccines. For example, are we allowed […]

486

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 […]

487

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.

488

What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've […]

489

Where can I get the detail guidance around layouts (ie, font size, specific/mandatory placement of info etc)? Thanks. Assuming you mean guidance about fair balance size, placement… Here is the link you are looking for. http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Base_Fair_Balance_Level_Selection_and_Placement.pdf

481

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.

482

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 […]

483

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 […]

484

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 […]

485

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 […]

Retour en haut