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We are holding a patient conference where there will be sponsoring companies exhibiting. Some are companies that have Rx products and some are companies with OTC products. What are the guidelines for the exhibitors in both cases? What are the limitations, in particular, for the Rx product companies with respect to promoting their therapeutic products? The audience is a mix of patients who have several different diseases, as well as the general public.
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View Answer [+]
The consumer advertising rules apply. With regards to promoting Rx products, the advertising is restricted to name, price, and quantity. Alternatively, the manufacturer can create information pieces which don't fall into the advertising realm (e.g. Consumer Brochures or Help Seeking Messages). Refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities".
When promoting OTC products to consumers, the product's therapeutic use can be promoted (provided the promoted indication does not relate to treatment of a schedule A disease). Please refer to the Health Canada policy document "Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)".
216
Would a RX script pad require PAAB approval? The pad will contain taglines from a PAAB-approved ad. Thank you.
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View Answer [+]
PAAB pre-clearance requirements apply irrespective of the format/media. If it is drug advertising and it is directed to HCPs, it is PAABable. In your case, we would review the tagline in its current context. Note that fair balance requirements would apply. We'd also urge the manufacturer to ensure that distribution of this "Rx script pad" does not contravene the Rx&D code.
PAAB does not adjudicate the Rx&D code but we are aware of prior rulings relating to Rx pads.
215
Dear PAAB Can a sales rep distribute a patient booklet that has been independently created by patient group? Can they distribute the booklet if their company sponsored the creation of the booklet? Many thanks.
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View Answer [+]
I presume the booklet is distributed by reps to HCPs (and the HCPs then distribute to the patient). Reps should not be distributing content to patients. With this understanding, the answer is yes. BUT, please note that the piece requires PAAB review if the manufacturer had any influence over content creation. Examples of "influence" include (but are not limited to): detailed direction on content or scope of research, review privileges, selection of writer...
214
Do the same rules apply to unbranded materials as branded? For example, Can I use review papers to discuss disease category education? What materials are acceptable to use as reference? Thank you!
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View Answer [+]
Editorials are reviewed under section 7.6 of the PAAB code. The PAAB code does not differentiate between branded and non-branded APS with regards to standards of evidence. The main difference between a branded and non-branded APS is that all content is inherently linked to the sponsor's product in a branded piece (this means that even non-drug content must fall within the limitations of the sponsor's product monograph). Review papers are not accepted to support drug claims. Review papers are only considered for disease information. The reference requirements depend on the claim type. This is not a "one or two paragrapher". We'll be discussing evidence standards in our October workshops. In the meanwhile, feel free to scan the Q&A category "Claims & support/references for claims" then either call the PAAB office to pose a quick general question or submit a request for a written opinion on your specific scenario (see PAAB website for fee schedule) if your question remains
unanswered.
213
Dear PAAB, I am curious about creating unbranded educational material around Subsequent Entry Biologics. We know that there are potentially alot of issues that SEBs can have considering the nature of the manufacturing process. Is it acceptable to educate physicians on the challenges, risks, and non-identical nature of SEBs vs. orignial product, using review and 'expert opinion' articles in an unbranded piece? Alternatively, if we had a study that was done that showed these issues would we be able to use that? Or is it, if Health Canada has approved it then we can't say anything to infer challenges and risks? Many thanks.
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View Answer [+]
The piece you have described would be reviewed as an editorial (i.e. "unbranded" piece) under PAAB code s7.6. As a general principle, advertising should promote the sponsor's product by its own merits rather than by calling attention to the limitations of competitors (whether perceived or factual). The hypothetical piece you are describing risks being disparaging. Clients are sometimes surprised to learn that "Factual" and "misleading" are not necessarily mutually exclusive.
Also note that class/category claims are generally not accepted. Given the variability within any given product classes and categories, it is misleading to make sweeping class/category statements.
Finally, drug claims should not be based on review papers or expert opinion. The opinions of an individual are not necessarily consistent with broader current medical opinion. Comparative efficacy and safety claims require double blinded head-to-head RCTs.
212
Am I correct in reading that:
- a reminder ad cannot be used for 2 years following introduction
to Canadian market? (and then, only if no new serious events that
warranted a warning letter from HC)
- reminder ad is exempt from PAAB but must be submitted to HC as
labeling?
- ad must include where monograph/full PI may be obtained in
Canada, the full name & address of manufacturer and any special
restriction in use or distribution
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View Answer [+]
Healthcare professional targeted reminder ads:
A and C are correct for healthcare professional reminder ads only. The complete list of requirements for HCP reminder ads can be found in the PAAB code section 7.4.
B is incorrect. Healthcare professional reminder ads are not exempt from PAAB preclearance as they are required to meet the provisions in PAAB code section 7.4.
Reminder ads open to the general public:
For consumer reminder ads, the PAAB provides an advisory service. As per Food and Drug Regulation C.01.044, reminder ads that are open to the general public must not exceed name, price, and quantity and therefore should not be linked in anyway to messaging about the products therapeutic area (e.g. the ad is prohibited from including the monograph or PI). Unlike for HCP reminder ads, there is no restriction relating to how long the product has been available on the Canadian market or how recently a serious event warranted a letter from Health Canada.
211
Since Jan 2009 Q&A, is there update further to Question #84 on distribution of reprints and Health Canada/PAAB postiion?
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View Answer [+]
The answer to Question #84 has not changed. Health Canada is ever vigilant of off-label promotion and unsolicited distribution of reprints by pharma reps is a tactic that can do that. Therefore, the PAAB advises companies to train their reps well and restrict the materials they hand out, to those that meet the requirements of the federal law and the PAAB Code of Advertising Acceptance.
210
Would PAAB approval be required for cards containing the Ontario Drug Benefit (ODB) Reimbursement Codes for a drug class?
- content is copied verbatim from the ODB website
- OBD website/URL is referenced
- no mention of drug name or drug logo
- no mention of pharmaceutical company
- to be distributed by drug rep
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View Answer [+]
Caution should be used when editing official government documents, which you are basically doing here. Context is important. You may want to seek permission from ODB to edit the information in the manner you are stating. The PAAB has received complaints from provinces about some marketing activities that included editing information or forms. If no drugs are mentioned, and the province has no objection, the item would not require PAAB review. It is better to hand out the entire published document, unedited.
209
I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!
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View Answer [+]
Yes, the video should be reviewed by PAAB as it exists due to the sponsor's funding (i.e. not independent created) and it will focus on the sponsor's product. See PAAB code s6.6 (a). Assuming that this is a prescription product, note that the content on the website should be gated (i.e. the general public should not have access to the content as it will invariably exceed the name, price, and quantity restriction). The PAAB will review the patient content under PAAB section code 6.4.3. PAAB will also be reviewing the contexts in which you are linking to the video in other APS.
208
Hi there I was wondering if we would need to PAAB-approval formulary announcements to physicians if conditions for benefit on the formulary in their province are to be listed in the announcement. Example for coverage on provincial plan:
- Patients are over 4 years old
- Cared by a physician experienced in managing seizures associated with LGS
- Already on two or more antiepileptic drugs in whom topirimate, lamotrigine and other expensive drugs are ineffective or inappropriate.
Thank you
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View Answer [+]
Yes. APS comprised of a formulary announcement which includes a conditions for benefit requires PAAB review. See question & answer #201.
