197
When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.
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View Answer [+]
The Health Canada Policy document "The Distinction Between Advertising and Other Activities" has a section on formulary kits. The kits are materials prepared for review by pharmaceutics and therapeutics formulary committees, on which a decision to include a drug product in a formulary may be based. Such information may not be advertising provided the information is limited to that which would normally be required to support such an application. If this is the case, there is no need for PAAB review. Where such an information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned. In these cases, the material should be submitted for PAAB review. Note that the PAAB has received complaints from provinces about unrequested promotion that should have been PAABed.
196
I understand a branded paid search ad cannot use keywords that go beyond name-price-quantity. However, if a person searches for the brand name keyword in conjunction with the disease-state keyword, does this not identify them as a patient or someone who is already knowledgeable about the product? Could a branded ad be presented if the searcher has already made the brand-disease connection themselves?
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View Answer [+]
No. There are only 3 audiences from a drug advertising regulatory perspective. Consumers, patients, and HCPs. Conducting an internet search containing the drug and the corresponding disease does not make you a patient or an HCP. The composite of the purchased keywords, the metadescriptor, the landing page and its URL must not exceed name, price, and quantity for a prescription product. These elements may not create a link between name and therapeutic use for a product indicated for the treatment of a schedule A disease. On a separate note, keep in mind that product ads cannot be directed to patients anyways (i.e. for Rx products, patient information must be non-promotional).
195
If a company wants to make physicians aware of an optional training program by sending a letter, will the letter be reviewed by PAAB or it is content-dependamt? Any guidance on the training materials provided to physicians at the training?
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View Answer [+]
Can PAAB review it? Yes. Does the code require that the content be reviewed? The answer is partially dependent on content (both the content on the invite and the content in the "training program"). BUT, a more comprehensive way to approach this is to ask yourself "is this advertising?" I refer you to the Health Canada policy document "The Distinction Between Advertising and Other Activities". It Invites us to determine whether the advertising regulations apply by assessing the answers to the following 7 questions:
- What is the context in which the message is disseminated?
- Who are the primary and secondary audiences?
- Who delivers the message (the provider)?
- Who sponsors the message and how?
- What influence does a drug manufacturer have on the message content?
- What is the content of the message?
- With what frequency is the message delivered?
Content is only one of the 7 factors. No one factor in itself will determine whether or not a particular message is advertising. If it is advertising and it does not meet the exemption criteria in PAAB code section 6.6, the letter should be reviewed by the PAAB. We can help you determine whether it is advertising if you submit an opinion through the eFile system (i.e. we'd need the answers to the above 7 questions).
194
If a DIN-gated patient website has been approved, can Sales Representatives showcase the website to physicians?
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View Answer [+]
A sales representative can showcase the website to physicians. The activity should be tailored to informing the physician that the site exists (such that he/she knows to direct patients who've been prescribed that particular medication to the site). The sales representative should not be detailing off of the patient site under the pretense that this is HCP targeted content.
193
Hi, If a company has a DIN for a human pharmaceutical, but does not have a vet DIN, are they allowed to advertise it, provided they are transparent that it is not vet DIN approved? Thanks!
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View Answer [+]
Veterinary advertising does not fall under the scope of PAAB.
192
Is it necessary, whenever a letter pertaining to your product is sent to a government official (either elected or part of the public service, at all levels of government) to include a copy of the Product Monograph if you refer in passing to an issue you may be having as it relates to your drug. For example, if we were bringing to the attention of Minister XYZ about Product A not being approved fast enough by internal bodies to meet the demands of physicians/patients, would we then have to include the PM simply because we mentioned the name of the product? Also, is it necessary, in private correspondence to government officials that is exempt from PAAB pre-clearance and non-promotional, to include both the generic name of said product, the dosing information, etc?
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View Answer [+]
The advertising regulations apply to advertising. A letter sent to a government official is a one-on-one correspondance (i.e. the advertising regulations would not apply). The letter should be non-promotional. It is therefore advisable that this activity not to be overseen by the marketing department. Although the activity we've described is likely not subject to the provisions of advertising, it would appear to be a good idea to include the PM or PI as a comprehensive resource for product information.
191
I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")
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View Answer [+]
Whether the title contains the word "guideline" is typically not in and of itself a pivotal factor in PAAB approval. It is more important that the source be reliable and authoritative. Statements taken from Canadian authoritative guidelines (e.g. place in therapy) can be considered in drug advertising provided they are consistent with the Terms of Market Authorization (s3.1) and based on good evidence. While some guidelines are published, they may not be endorsed or recognized by an authoritative medical body and therefore may not be reflective of current medical practice (s3.2). Note that a nationally recognized consensus would be preferred over a regional consensus.
Note that content from Canadian authoritative guidelines is not automatically accepted in APS. All PAAB codes must be considered.
190
Hi there, If a company wants to write a private letter to MPs, Senators, government officials (elected or appointed) with regards to their product, issues a company is facing with regards to approvals/existing regulations/legislation etc, does that letter require PAAB approval? To what extent are pharmaceutical companies required to submit letters to government officials to PAAB for review/approval?
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View Answer [+]
A letter to an MP, Senator, or government official would be exempt from PAAB preclearance. The letter should be issue oritented and not promotion oriented. We've been made aware of complaints relating to formulary bodies receiving drug advertising.
189
Dear PAAB: We have a HCP-directed APS for a congress announcing "Company A name" and "Product B name" are "now here" in Canada. An offer to "visit at Conference Booth XXXX" is included. There are no further product / therapeutic claims.
- Is this exempt from PAAB preclearance review, as per the "now available" exemption in S6.6?; and
- If so, may we include product branding elements / visuals and maintain exemption?
Thanks!
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View Answer [+]
The specific examples listed in PAAB code section s6.6 would be considered exempt. When using alternate copy and/or adding visuals, I suggest submitting a written opinion request for exemption (i.e. we'd need to view the specific piece for assessment).
188
Are printed PI pages still required for journal print ads, or can a web site be given within the ad directing the reader to the PI? Assume that claims are being made within the ad. Thanks
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View Answer [+]
Printed PI pages are still required. Please refer to PAAB code sections 6.1, 7.1, and 7.3. The current PAAB code can be accessed at the following URL:
http://www.paab.ca/local/files/PAAB%20Code%20Eng%20April%2017%202009.pdf
Stakeholder consultation regarding draft PI requirements proposed by an expert committee is currently ongoing. Health Canada will be providing input. See the following URL for more information:
https://www.paab.ca/resources/paab-code-app/
A PAAB code change would require at least two-thirds of the PAAB Board of Directors to vote in favour of the change. Please call Patrick Massad at the PAAB if you have any questions.
