57
How do you approach companies to support your organization?
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Voir réponse [+]
Offering a voluntary advertising preclearance review program on a fee-for-service basis, the PAAB is a not-for-profit association with 11 association voting members and three individual members. The members include three major pharmaceutical industry trade associations, Rx&D, NDMAC and CGPA. The trade associations encourage their member companies to participate in the voluntary PAAB submission review preclearance program. Also, Health Canada, which is responsible under law for enforcing pharmaceutical advertising regulations has delegated the day to day role of guiding responsible, legal advertising to the PAAB. Health Canada recommends that all companies adhere to the PAAB Code of Advertising Acceptance. As part of a monitoring function, the PAAB staff will contact advertisers who are not following the PAAB code and advise them to send their advertising to the PAAB. Health Canada is copied for any necessary enforcement under the Food & Drugs Act.
56
Can you use a current FDA approved US Prescribing Information as a reference for PK data?
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Voir réponse [+]
The PAAB Code section 3.1 clearly states that all claims must be consistent with the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved PI would not meet that requirement. The TMA does contain a section referring to pharmacokinetics data and PAAB would look at that section for support.
55
What happens if our Product Monograph changes between the time of getting PAAB approval on the format of the Prescribing Information and printing of the PI? Since PAAB is only approving the format, would it just be a matter of sending you the updated prescribing information for your information and records (assuming the format did not change)? Thanks.
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Voir réponse [+]
PAAB Code section 7.3 clearly states that the sponsors are responsible for the content of the prescribing information (PI) while the PAAB will review the PI for format requirements. All initial changes to the new PI format should be submitted and reviewed by PAAB (as of July 1, 2007). Assuming that the format has not changed from the initial PAAB reviewed PI and only the content has changed, resubmission would not be required. However, you should send us the updated version for our records.
54
Can we create a program that is directed towards patients as the recipients? Is this considered advertising (direct-to-consumer)? Would it require PAAB review? The content within the program would be on-label.
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Voir réponse [+]
Patient support programs are widely used in the market place. They are directed to patients only and are not suitable for "direct-to-consumer" audience. Patient support programs are intended to help patients gain a better understanding of the drug therapy that they are being prescribed. The information should be consistent with the patient information section of the product monograph (Section III of the monograph) and presented in a non-promotional manner. Patient directed materials are subject to the PAAB review as per PAAB Code section 6.4.
53
Are vaccines treated the same way as prescription drugs for advertising purposes? For DTC, can the brand name of a vaccine be mentioned?
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Voir réponse [+]
For the purpose of the PAAB Code, advertising for vaccines are treated the same way as for prescription drugs e.g. consistency with the monograph, evidence for comparative claims, data presentation, etc. For Direct-to-consumer (DTC) advertising, the brand name of a vaccine can be mentioned. We would need to look at the entire context to determine whether there are other issues.
52
What is the PAAB's expectation with regards to the PI for journal ads that were approved and have been in publications prior to July 1st but have also been booked post July 1st for the remainder of the year? (Repeat of existing ads for monthly journals)
My concern is that we have paid for a specific number of pages within the publication based on the old PI format. The required number of pages will most likely change as we update the PI with the new format.
Obviously, we will update the PI for any new ads that we are creating and having approved.
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Voir réponse [+]
All materials that have been approved and used prior to July 1, 2007 will remain unaffected until the expiry date, however, any new submission for a new journal ad will require the new PI format. You can always contact the PAAB office for queries on specific projects.
51
There are two rumors circulating that I don't believe. Please comment/advise.
Come July 1, 2007, will medical journal publishers be expected to lay out Prescribing Information in their journals in alphabetical order by drug name?
When all ads finally have the "new" format and include page referencing to the PI on them (assuming all publishers are putting a folio on all their pages so every page has a page number) should/can publishers do away with the Ad Index?
Ad Indexes are like the TOC (Table of Contents)--but for ads in journals. Medical Post does not include an Ad Index, but all other journals (I think) do. I know these sound like CAMP issues--pls help with PAAB's opinion as there is not a consistent understanding amongst publishers on these 2 issues.
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Voir réponse [+]
The issue of laying out the PI in a particular order is not a PAAB Code requirement and also does not appear to be covered in the CAMP guidelines. We suggest that you seek clarification from the individual publishers who have their own guidelines. Keep in mind that the PAAB Code s7.3.5 only requires that the page number of the PI appear in the ad portion. Regarding the "ad index" issue, it is a matter that should be raised with the individual publishers as it is not considered a PAAB Code issue but more likely an operational issue with the publishers.
50
To restrict access to patient web site we usually use the DIN as an accepted method of verifying that the visitor is indeed a patient before granting access. But we are currently working on a web site for a drug where the patients never receive the product packaging. Some of them might be able to find the DIN on their drug store receipt but some receipts don't have that information.
Are there other accepted methods of restricting access to a patient web site in case the DIN is not available?
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Voir réponse [+]
Yes there are other methods of restricting web access to specific patients. Alternatively to a DIN password, healthcare professionals (doctors or pharmacists) could provide the individual patient sign-up information to mail in or go to a web-site url to register for access and obtain a password. The onus is on the sponsor to gate access to the product information to ensure that only patients taking the product have access to the site.
49
Can a product manager or medical manager provide a slide set to a customer upon request if the slide set contains off-label information?
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Voir réponse [+]
As per the PAAB Code section 6.6, person-to-person requests (that are unsolicited) are exempt from the PAAB review and the Medical Department (Medical Information) should be handling such requests. If the off-label information was not part of the request, then it should be removed (unless the customer specifically asked about the off-label issue).
48
I have already submitted a product's website copy for PAAB approval; however I was hoping to receive clarification around the requirements for submitting the website layout to PAAB:
Is it sufficient to send the design for a few of the different pages within the site, or would you prefer we submit all pages included within the site?
Should we be submitting the design once the copy has been PAAB-approved, or can we submit simultaneously?
Does PAAB like to review the actual website before launch?
If you could provide a few details around website layout submission, it would be greatly appreciated. I've referred to explanatory note 6.5.11 for guidance.
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Voir réponse [+]
Ideally we would like to review the entire website as it is intended to be presented. So, yes, the layout/ design should be submitted in conjunction with the copy deck in order for the reviewer to assess the material in full context. However, we recognize that this may not always be feasible and would agree to review the copy deck first and the final layout at a later stage following copy approval. Finally, we would prefer receiving the entire layout /design rather than a few pages at a time.
