162 - Please advise as to whether there are any particular requirements related to a US manufacturer providing medical information letters to Canadian physicians' unsolicited requests for information for a drug not authorized for marketing in Canada. The letters would be intended only for medical information, not for advertising purposes.
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The physician should be directed to contact the medical department of the Canadian subsidiary (in cases where one exists). One of the main concerns is potential confusion regarding the status of Health Canada approval for a product or a use. For example, in cases where a product or use is approved in the US, the US manufacturer would send a US Brief Summary for that product in addition to the specific response. This could potentially confuse/mislead a Canadian physician into thinking that a product or use has been approved here in Canada. In cases where there is no Canadian subsidiary (i.e. this medical service will need to be provided through the US), ensure that a US Brief Summary is not provided. This may require training of the medical department staff as it is counterintuitive. Aside from this nuance, the regulations pertaining to US manufacturers responding to unsolicited requests from Canadian physicians are the same as those pertaining to Canadian manufacturers. As per the Health Canada policy document The Distinction Between Advertising and Other Activities: "Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug". The response should be limited to that which is required to answer the specific request. It is advisable for the medical department to document the details regarding the request (e.g. date, name of requester, nature of request, content provided, etc). Please call the PAAB if you have any further questions about this.
