499 - We are experienced in submitting DTCI campaigns through regulatory. In these cases, the focus is on the disease and when mentioning drugs, we discuss all treatments indicated for that disease (because there cannot be undue emphasis on any one drug). However, we wish to know about the DTCA of vaccines. For example, are we allowed to talk about the indication/side effects/dosing, etc for one vaccine specifically without mentioning the other vaccines indicated for the prevention of the same disease? In this case, it'll have the "undue emphasis" which is not permissible for schedule F drugs.
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The provisions you mentioned for DTCI relate to ensuring that the material is not subject to advertising regulations. This is often a consideration because consumer advertising materials for products in the “prescription” schedule are restricted to name price and quantity. Vaccines are schedule D products. Manufacturers may promote the therapeutic use of their vaccines in consumer advertising. If doing so, it is important to include fair balance as per the following Health Canada Interim Guidance: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_dtca-pdac_vaccine-vaccins-eng.php The PAAB reviews for Rx & Schedule D consumer materials are based on our interpretation of the Food and Drugs Regulations and the Health Canada policy document “The distinction between advertising and other activities”. See the fee schedule on our website for details.
