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177

We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?

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  Updated October 19, 2015. Risk management tools should be submitted for PAAB review even when they have been approved by Health Canada.

  Health Canada has requested that risk management tools (whether targeted to HCPs or provided to patients through HCPs) be reviewed by PAAB.

  In those instances in which Health Canada has reviewed and approved the pieces, their review focuses on scientific accuracy of the content. Health Canada has therefore asked PAAB to review the pieces to ensure that they are not promotional. At the end of our review, PAAB sends the final piece to Health Canada for their records.

176

Is there any guidance about websites designed for the provision of medical information to registered heath care profesionals in Canada. These sites are non-promotional and allow HCPs to access information after having completed a specific search on their own. The obvious advantage is to allow 24/7 access to information useful to help in patient care.

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  The Food and Drugs Act, the PAAB Code and The Rx&D Code of Ethical Practices have requirements regarding provision of information when it is "advertising". Advertising is regulated, non-advertising information is not regulated. The Health Canada document "The Distinction Between Advertising and Other Activities " states the requirements to make information become non-advertising http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php in any media. The "PAAB Code of Advertising Acceptance" section 6.5 covers internet activities sponsored by pharmaceutical companies.

  See also the Health Canada policy "Health products advertised on physician websites" at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/web-qa-qr-eng.php Therefore, if the site is truly non-promotional, it is not regulated.

  The following best practices would increase your chances of keeping the site outside of the "advertising" (i.e. regulated) realm:

  • The website shall be set up such that the process for requesting information mirrors the process a healthcare professional would follow if they were to call the Medical Information Department directly.
  • The platform is kept separate and distinct from any advertising.
  • This service will be defined by the following three characteristics: restricted access, specific key-word based searches, and documentation.

  Restricted access: For example, only healthcare professionals can access the website. They do so by entering a user name and password provided after completing registration. Registration includes a mechanism which ensure that the registrant is indeed a healthcare professional.

  Specific key word searches: For example, medical information responses provided in the form of medical information letters (MILs) addressing specific questions. The MILs would be the same as those used to respond to verbal requests. The MIL responses would be accessible by entering specific key words into a search engine. Those key words are exclusive to each letter such that a key word entered could only result in the retrieval of one letter (i.e. it will not be possible to perform general searches based on text words).

  Documentation: For example, the system would be configured such that it is possible to identify users to whom specific MIL responses have been provided. The user, the date, the keyword search and the information provided would be recorded by the system.

175

Dear PAAB. What jurisdiction does PAAB have over reprints and in particular reprints that may not be acceptable for promotional material but are consistent with and within indication. An example would be a review article?

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  Journal reprints per se are not subject to PAAB review. If they are consistent with the Terms of Marketing Authorization they can be distributed complete and unmarked (no emphasis). That can include review articles. Please remember that when journal reprints are distributed in a promotional manner i.e. detailed by reps or are used as references to support advertising claims, they must meet all the requirements of the PAAB code, especially s2,3,4 and 5. They can be distributed by the medical department upon request for specific information and not be considered advertising. See also "The Distinction Between Advertising and Other Activities" and the Rx&D "Code of Ethical Practices" which have requirements specific to journal reprints. The Distinction document says this about textbooks and reprint articles:

  "Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that: no link between the text and promotion of a drug is established by the manufacturer.
  Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example: the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid), the material was written or edited by an employee or agent of the pharmaceutical manufacturer, a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material, reference is made to the availability of an unauthorized drug through the Special Access Programme."

174

Dear PAAB: Does inclusion of a product Name, and its associated DIN, adhere to name/price/quantity guidelines in c.01.044? Does package size (i.e. weekly, monthly and number of tablets) meet the regulations for quantity? Many thanks.

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  Including the DIN in a reminder ad for a prescription drug directed to consumers does not adhere to the letter and spirit of Section C.01.044 of the Food and Drug Regulations. As you may be aware, reminder ads are acceptable provided that there is no allusion or link to the therapeutic indication of the advertised product. However, as it is often the case with reminder ad campaigns, market authorization holders set up a branded prescription drug Web site where patients who have been prescribed the prescription drug can enter the DIN in order to get access to the full product information. This practice has been deemed acceptable by Health Canada as it acts as a mechanism to restrict access to patients, and not the entire general public. Therefore, in such a scenario, providing the DIN in a reminder ad would likely constitute a direct-to-consumer advertising in contravention of Section C.01.044. With respect to your question about package size, we would suggest that you restrict the quantity claim such that it relates to the number of units provided for the price, as this will provide accurate information as to the unit price. If your question is more related to product package representations, we invite you to consult the Health Canada policy entitled "Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers" available at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/notice-avis_reminder-rappel-eng.php.

173

Do personal (i.e. one to one, not mass generated) emails to HCPs announcing a product is "now available" need PAAB pre-clearance review? May such emails that mention a product also include brief mention of the general indication, disease state or therapeutic use? Thanks!

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  No, PAAB preclearance is not required for any piece containing only the drug name and the claim "now available" s6.6. This is true whether the same piece is sent to one HCP or many HCPs. However, adding anything else (e.g. the indication, disease state or therapeutic use) renders it PAABable.

  Additional related notes:

  • Situations where the piece is provided to an individual in response to a request for information that has not been solicited in any way is exempt from pre-clearance. It appears unlikely that an HCP requests a piece containing the message "Now available" and the product indication. s6.6
  • Note that simply personalizing the greeting line (i.e. Dear Doctor John Doe) does not render the piece exempt for PAAB preclearance when the intent is to send the core message to multiple HCPs.

172

Can we use a 2D / 3D scan tag, QR Code to carry the prescribing information that may otherwise be physically attached to the collateral?

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  No. PAAB code section 7.3 states that Prescribing Information (when required) must be attached to the presentation or be distributed with it. A scan tag or QR code would not meet this requirement. Health Canada confirmed recently that this also remains their current position. An APS which fails to meet the prescribing information requirement may be contravening section 9.1 of the Food and Drugs Act. The PAAB is currently working on proposing alternative PI presentations, and will approach Health Canada with a report/request after appropriate analysis and stakeholder consultation.

171

If a physician who was not able to attend a congress/confrence(e.g. ASH, ASCO, ADA) requests through medical information slides on company studies presented at the congress are we allowed to provide them?

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  The Health Canada policy document "The Distinction Between Advertising and Other Activities" does not consider responses to specific questions from a medical info department to be advertising. The request should be SPECIFIC and DOCUMENTED. Such a response would be exempt from PAAB preclearance review in accordance with Code s6.6(b). We remind you that, while a company may promote the fact that it has a medical information service, it should not promote individual studies that are not consistent with the product's Terms of Market Authorization (TMA). If drugs are mentioned in an institutional message, even within study titles, PAAB preclearance review is required per Code s6.6(e).

170

When introucing a new drug can we put the Health Canada classification, i.e. Angiotensin II receptor blocker or angiotensin receptor blocker of the drug on the same page as clinical information.

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  It is possible for the Health Canada pharmacological classification and claims within the limitations of the Terms of Market Authorization to appear on a single page. However, to avoid according clinical significance to the pharmacological classification, the claims will need to be presented such that they are separate and distinct messages. Call the PAAB office if you have any questions.

169

Can PAAB provide some guidance on the use of physician quotes in promotional material? Can video clips of physician quotes be used at conferences?

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  Physician quotes can be used in advertising. Quotations should be verbatim (and in the same context as the source) with any deletions identified by a series of dots. The sponsor is responsible for securing permission to quote the physician where this is necessary. If it is a fictitious doctor, a disclaimer should clearly disclose this. Aside from that, physician quotes in advertising are held to the same standards as the advertising copy which accompanies them.

  Physician opinions or testimonials are non-evidenced based statements (s3.1.3). Therefore, any statements or claims made in the quotation must be supported by, and referenced to, rigorous evidence. For example, all statements and claims should be within the limitations of the Terms of Market Authorization (PAAB s3.1), statements about place in therapy should also reflect the Canadian consensus guidelines (PAAB s3.2), some statements and claims may require insertion of qualifiers or quantifiers within the APS, and so on.

  Some companies prefer to give the healthcare professional (HCP) a pre-approved script (or at least speaking points) in order to obtain a larger number of usable quotes from him/her. Don't assume that physicians know advertising regulations. Remember too, that PAAB review is a regulatory review, based on the Terms of Market Authorization and the entire PAAB code.

  If your objectives call for more free and open dialogue with the HCP, it is a good idea to submit the questions to PAAB for a written opinion ahead of time. Often, asking the question the right way can improve the odds of getting an answer which can be accepted in advertising. It is also a good idea to inform the HCP about the pertinent advertising regulations. The fact that a doctor said it does not exempt it from the regulations. Ultimately, the sponsor is responsible for all advertising content including HCP quotes.

168

For our Vaccines web sites which are branded, we would like to include a link to our unbranded Digital Video News Release (DVNR) which will be housed on YouTube. We are also considering storing a PDF version of our unbranded matte stories on the website. Is there any concern with placing unbranded materials on a branded web site? Does it matter if it is a Vaccine or Rx product?

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  With respect to your specific questions, the main concern with placing unbranded materials on a branded web site is that you would be linking the unbranded content with the brand (i.e. this could essentially "brand" the "unbranded" content). There are multiple implications to this (and this is where the federal schedule of the product comes into play as per your second question):

  Advertising for all products (whether Rx or vaccine) must be in accordance with the Terms of Marketing Authorization granted by Health Canada . If the disease content on the video extends beyond the indication of the product featured on the site, the sponsor may be violating section 9(1) of the Food and Drugs Act.

  Specifically for websites promoting an Rx product or a product indicated for the treatment of a schedule A disease, there is an additional concern. The consumer accessible portions of such websites should not link the product to its therapeutic use. An unbranded disease video may do this.

  The PAAB can help you get it right through the preclearance review program and/or opinion advisory for DTC advertising. You should familarize yourself with the "Press Releases" section of the Health Canada document "The Distinction Between advertising and Other Activities" because your You Tube DVNR site may not meet all of the requirements of an exemption for advertising.