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Pages: 2, Size: 54 K, Date: 2007-12-03


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December 3, 2007

Our file: 07-127244-163

Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers

Section C.01.044 of the Food and Drug Regulations restricts the advertising of a prescription drug to consumers to the mention of the name, price or quantity.

Under this regulatory framework, Health Canada has permitted two types of prescription drug messages directed to consumers, Reminder Ads and Help-Seeking Messages:

  • Reminder ads, where the name of a prescription drug is mentioned, but no reference to a disease state appears in the ad, are interpreted as not going beyond the name, price and quantity restrictions of Section C.01.044.
  • Help-seeking messages, where a disease state is discussed, but no reference is made to a specific prescription drug product, are considered information and not advertising when they meet the criteria outlined in the policy, "The Distinction Between Advertising and Other Activities".

Health Canada would like to clarify that depictions of easily recognizable product packages (blister packs, inhalers, etc.) that lead to the identification of the therapeutic indication of a prescription drug (Schedule F) in Reminder Ads are considered to exceed the consumer advertising limitations described in Section C.01.044 of the Food and Drug Regulations.

Health Canada has recently received a number of complaints regarding the inclusion of product package representations within branded Reminder Ads; specifically, campaigns which included ads depicting blister packs of oral contraceptive products. Most of the complaints alleged that such ads were not consistent with the federal regulatory requirements for prescription drug advertising to consumers.

Health Canada has reviewed these complaints and is in agreement that when advertising campaigns allow consumers to identify the therapeutic indication of a prescription drug through the disclosure of visuals of the package representations, the limitations of Section C.01.044 of the Food and Drug Regulations have been exceeded.

As a result, Health Canada has advised the Pharmaceutical Advertising Advisory Board (PAAB) and Advertising Standards Canada (ASC) of its above-noted position and to no longer accept these types of ads when providing advisory opinions on messages directed to consumers for prescription drugs.

Depiction of a generic packaging that does not divulge the therapeutic claims (i.e., box or carton) could be deemed appropriate in certain circumstances so long as it does not lead to the identification of the therapeutic indication. Advertising campaigns must be evaluated in their entirety. Both the content and the context in which the ad is being used are of the utmost importance in determining conformity with advertising requirements. As such, case-by-case assessments are required and Health Canada strongly recommends that in order to ensure that advertising campaigns do not exceed the limitations expressed in C.01.044 of the Food and Drug Regulations, industry have all advertising of marketed health products reviewed by one of the preclearance agencies, listed in Section 3 of the List of Canadian Advertising Preclearance Agencies.

For further information, you may contact:

Marketed Health Products Directorate
Therapeutic Effectiveness and Policy Bureau
Regulatory Advertising and Risk Communications Section
Tunney's Pasture, A.L. #0701C,
Ottawa, Ontario K1A 0K9
Fax: (613) 948-7996