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87

We are producing a directory of canadian clinics that offer a specific test. There will be an introduction outlining why the test is important, how it is done etc. The booklet will be sponsored by a drug company (corporate logos will be on the cover) but there is nothing in it that mentions their or any other company's drug products (and they have no affiliation with the tests, clinics or instruments used). The booklet will be distributed by the sponsors reps as a service. Healthcare providers will offer independent review of the content. Does this require PAAB review?

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  This item as described would not require PAAB review.

86

Could you give me any clue about the adversting or marketing expenses limit set by the government for a pharmaceutical company in a year?

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  We are not aware of any government regulations regarding marketing expense limits in Canada.

85

Could you please confirm for me whether or not a Dear Doctor letter outlining a Nursing Assessment program needs PAAB approval. The program is being run by a 3rd-party. The letter does not contain any information about product and it outlines the parameters of the program itself (i.e. # of patients needed to be recruited, length of day, etc.) The Dear Doctor letter is being left with the doctor and it is being delivered and signed by the representative.

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  This question is too vague for us to answer. We would need more details than this to give proper advice on its status regarding adverting law and the PAAB code. You can always call the PAAB Chief Review Officer Patrick Massad for free verbal advice; the PAAB charges a fee for written opinions including e-mail.

84

Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB's rules around distribution of these types of articles by drugmakers representatives.

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  Answer as of January 19, 2009 because it is time-sensitive. The U.S. FDA document is a "Guidance" out for comment and it is not law, so caution in interpreting it is needed. Also, it is very complex and you can see the whole thing at http://www.fda.gov/oc/op/goodreprint.html. There are lots of caveats and requirements to meet. Read the disclaimers carefully. This guidance replaces the FDAMA 401 provision that expired in 2006 (since 2000). The FDA has been wrestling this issue since then. Keep in mind the US government has changed to a Democrat driven government in both the presidency and the House, and Health Care reform is now the number two issue behind the economic situation. There are a number of hawks that are interested in reining in pharmaceutical industry marketing practices and several have spoken against this guidance. A new FDA Commissioner will be selected soon by the new House and we will see what will be the new direction. Keep in mind Eli Lilly just got hit with a 1.4 billion dollar settlement for alleged criminal action regarding off-label promotion during the period 1999 to 2003. There are a number of other recent off-label cases that the Department of Justice and Office of the Inspector General (not the FDA) have acted on. I have recently asked Health Canada about any action in Canada to move in this direction and the answer is "no". Remember that advertising laws in Canada are not the same as laws in the USA.

83

Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners tradaemarks.

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  Please see Code section 8.4 (a) which allows a maximum period of 12 months for PAAB clearance acceptance of all Advertising/promotion Systems (APS) that do not include market share or price claims. If the APS is to be used longer than 12 months then the sponsor should submit a renewal submission request for pre-clearance review. Information about the drug or marketplace conditions may change over time.

82

We are currently preparing our submission for a new product to Health Canada. In the meantime, the company is preparing it's financial report for the investors and they would like to include a section on the disease, it's implication on patients and a section on the molecule itself with results of it's phase III trials. Are there any restrictions, and/or do we have to submit the report to PAAB?

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  There are restrictions. From a regulatory perspective, you could do something as a "Press Release" following the category requirements in the Health Canada guideline "The Distinction Between Advertising and Other Activities" available on the HC web-site or found through a link to HC in the "Resources" section of the PAAB web-site.. If done properly and it is not promotional in nature, it would not be considered "advertising" subject to PAAB review. However, please note that if the activity does not meet all of the requirements for the advertising exemption, it would be considered "advertising" and subject to the provisions in the PAAB Code of Advertising Acceptance and possibly be in violation of the Food & Drugs Act.

81

Mon client doit faire une pièce visuelle descriptive de son produit qui sera remise aux professionnels qui l'utilisent, soit les médecins et les technologues.

Le produit se nomme SmartVent et c'est un système de délivrance radioaérosol qui permet la production d'imagerie de ventilation pulmonaire. Je ne suis pas certaine si cette publicité doit être envoyée à PAAB pour approbation car c'est un 'medical device'.

J'aimerais être certaine des règlements pour ce genre de produit.

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  PAAB ne passe pas en revue pas les appareils médicaux approuvés par Santé Canada (11.3).

80

I recently received a copy of your December newsletter which refers to changes that will be taking place on April 2009. With respect to 2.4.3, would you consider a non-prescription, schedule D vaccine to fall into this category? And what about a Schedule F drug, that is non-prescription in Ontario?

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  Schedule D vaccines would not fall into this category because vaccines are not considered to be "non-prescription" health products. They generally require health professional intervention similar to schedule F products. The PAAB recognizes federal health product regulations i.e. Schedule F requires a prescription for sale in Canada. I learned in pharmacy school jurisprudence that when two laws conflict, always defer to the more stringent law to avoid putting yourself in jeopardy. You can also refer to the NAPRA Drug Schedule categories 1 to 4 for guidance as to what is "non-prescription". When considering "nonprescription" think "self-selection" as a guiding principle.

79

Could you please provide some clarity around the definition on Formulary Kits as described in "The Distinction Between Advertising and Other Activities". Specifically, is it appropriate for a company's sales representative to distribute formulary kits to formulary committees in a hospital setting?

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  Sales representatives can deliver formulary kit information if the information has been requested by the hospital i.e. if the hospital has standard requirements and criteria for formulary listing requests and the company is meeting the request for that information. If the reps are promoting the product with information in the kit that is beyond the requested information, the company should seek PAAB review. If the audience is broader than the hospital requesting the information for formulary listing, then it would be considered to be advertising. See the "Distinction Between Advertising and Other Information" (Health Canada) for the HC policy. The PAAB has received a complaint from a formulary committee that was bombarded with information beyond what they requested.

78

Further to the Question #76, could you distinguish what 'special conditions' refers to?

Also, can the key clinical trial be used as support for NOCC advertising, even if it does not appear in the PM in its entirety?

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  The "special conditions" are stated in the product monograph approved by Health Canada. Hence "Notice of Compliance with Conditions" or "NOC/C". It is a tentative approval base don preliminary data and thus the expressed caution about the advertising approved by the PAAB. The conditions can vary by product and state which data the company must generate to remove the "conditions" tag.

  As with all claims based on data from a clinical trial that appears in the product monograph (PM), we would want to know if Health Canada (HC) has reviewed and accepted that data as relevant for promotion. It is up to the sponsor to prove that to the PAAB. We have had a few cases that HC had purposely left out data from the PM and the company did not tell us that. When in doubt, the PAAB will ask HC formally, with the advertisers consent. To repeat, the PAAB takes a cautious approach to approving advertising for products with an NOC/C and generally, data claims not in the PM for a product with NOC/C will not be accepted for advertising purposes. See Code s2.4.2 and the guidance on the PAAB web-site.