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147

I would like to understand what the average time (weeks/days) the PAAB currently are working to with respect to the review and approval of promotional materials from pharmaceuitical companies

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  The PAAB's mandate is to provide an initial response within 10 working days of receipt of all required materials (e.g. the advertisement & the references). In 2010, the PAAB has met this target for 99.5% of files. In fact, the median time to first response in 2010 was 7 working days. For revisions, the PAAB responds within 3 working days.
  
  Keep in mind that the time to approval is also determined by how long it takes for PAAB's clients to respond and how willing they are to address the issues raised by the reviewer. In 2010, it has taken an average of 11 working days for clients to provide their revisions to the PAAB versus 3 days for a PAAB response. In 2010, it took an average of 2.4 revisions to get an approval. Caveat: interpret these two client averages with caution as there is significant variability between different agencies/manufacturers. Call me if you would like to know averages specific to your company.

146

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145

When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year's? If so, do you accept submissions at this time?

Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?

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  As our submission process is fully electronic, you may submit new dockets at any time, day or night. The eFile system is fully operational 24/7. The PAAB office will be closed for the holidays on Friday Dec. 24, 2010 at noon and will reopen for business on Monday Jan. 3, 2011. The last day to submit a new eFile in order to ensure a first response before we close on the 24th, is Dec. 10, 2010.

  With respect to the "rule of 2 for initial docket submissions", I believe you are referring to pre-NOC submissions. You can submit up to 2 Pre-NOC pieces for review, as long as the monograph is at "FINAL DRAFT stage" with Health Canada. Pre-NOC pieces are not bound by the 10 day timeline for first response. For more information regarding pre-NOC submissions, please refer to the document "Administrative Guideline for the review of Pre-NOC advertising submissions" on the PAAB website

  There is no limit to the number of submissions you can make at any one time for APS promoting products/indications that have Health Canada approval. The PAAB will provide a first response within 10 business days. However, the timeline for response for Direct To Consumer pieces and Opinion requests is 4 business days.

  Please call the PAAB office if you have any further questions.

144

Les publicités de produits pharmaceutiques dans les médias spécialisés (revue médicales, associations professionnelles en santé) doivent-elles être accompagnées d'une monographie ?

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  Oui selon les sections 6.1 et 7.3 du code CCPP, les publicités de produits pharmaceutiques contenant des allégations de produits doivent être accompagnés par les renseignements posologiques. Notez que les renseignements posologiques ne sont pas exigé pour:

  • les systèmes publicitaires et promotionnels (SPP) de rappel (section 7.4)
  • les systèmes publicitaires et promotionnels (SPP) institutionnels (section 7.5)
  • les systèmes publicitaires et promotionnels (SPP) rédactionnels (section 7.6)
  • les messages pour lesquels les exemptions à l'examen du CCPP s'appliquent (section 6.6)

143

Is it permissible to give patients that have registered for an online patient support program, incentives or rewards to maintain their registered status? This is a DIN protected, branded site, that patients have registered and opted in to receive communications.

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  PAAB Code s2.5 covers activities that would compromise the ethics of health care professionals. The PAAB Code does not address the issue of patient incentives directly. Keep in mind that access to gifts is a provincial pharmacy act issue regarding incentives. You would therefore need to check with the individual provincial Pharmacy Acts (or perhaps NAPRA can be one stop for all) and the Rx&D Code of Conduct. We suggest to proceed with caution as giving gifts has been a troublesome activity for pharmaceutical companies in the past.

142

If we are providing co-pay assistance program through a third-party, do communications informing physicians/HCP of the program have to go through PAAB?

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  PAAB Code section 6.6(d) allows a review exemption for formulary announcements such as "now on formulary" not linked to a therapeutic message in any way. Covered uses are deemed to be therapeutic messages. Generally co-pay assistance programs would mention a drug and a therapeutic use and would fall under Code s7.5 "Institutional" messages with product mention which would require review. The co-pay message could be part of a product ad with claims s7.3, and that requires a review.

141

Can a pharmaceutical company have an SMS text message medication reminder sign-up on a DIN-protected website where patients can sign up for a daily SMS reminder to take their medication?

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  Yes, a SMS reminder to take the medication is acceptable when a patient signs-up to participate in such program on a DIN protected patient website. Note that this site would require PAAB approval. As part of the approval process, we would require to review the SMS message wording.
  There should be a mechanism to ensure that the person receiving the SMS is still on the product (i.e. he/she is still a "patient"). For example, simple instructions on how to discontinue SMS reminders should be provided.

140

If we place an ad in an HCP-focused journal, and provide a link to an HCP-focused website (either typed in or scanned using a 2-D scan code), can we assume that the audience has been sufficiently vetted as HCPs and provide branded drug information to them?

This would be in lieu of asking for licence numbers or other means of identification.

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  For prescription products and for drugs indicated to treat/cure Schedule A diseases, a gate of some sort is required to pose a true barrier restricting consumers from having access to the site. The relevant legislative authority is Section C.01.044 of the FDR and Section 3 of the FDA.
  
  The assumption in your question is only valid if the website is not searchable. In other words, the website could only be accessible to those who use the scan code or type that specific URL into the search field. Please call if you have any questions.

139

With regard to a diagnostic manufacturing company that manufactures glucose meters, etc. The company produces detail aids, etc. Do these detail aids require PAAB approval?

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  Advertising tools exclusively discussing items which have been approved by Health Canada as "medical devices" do not fall under the scope of the PAAB code. However, the piece should be submitted to PAAB if there is any mention of a drug product (i.e. DIN, NPN, DIN-HM, and Schedule C and D products).

138

In your answer to Question #137, you are saying that although it goes beyond name, price & quantity, the PM (in its entirety)is not considered advertising. So is it acceptable to link the PM to the banner ad in the consumer realm?

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  No. Because the product monograph contains content which goes beyond the name, price & quantity restriction, it may not be linked to advertising (e.g. a banner ad). For the product monograph not to be considered "advertising" it must be complete/unchanged AND it must not be linked to advertising (e.g. a banner ad). Health Canada had confirmed that linking the product monograph to a banner ad in a consumer realm would contravene C.01.044 of the Food and Drugs Regulations. Please call Patrick at the PAAB if you have further questions about this.