I• Health Canada Sante Canada Health Products and Food Branch Direction genera te des produits de sante et des aliments Marketed Health Products Directorate Address Locator #0701 D OTT AWA, Ontario KlA 0K9 9608-6-2 15-109308-390 August 12, 2015 Michael Gallo Duchesnay Inc. Vice-President Regulatory Affairs and Research 950 Michelle-Bohec BL VD BLAINVILLE , Quebec J7C 5E2, Canada Dear Mr. Gallo: Re: Kardashian endorsement of Diclegis on Iostagram Heahh Canada is the national regulatory authority for health product advertisements. Our commitment is that information in a health product advertisement is not false, misleading or deceptive. Health Canada requires that an promotional health product messages, irrespective of the media in which they appear, comp ly with the legislative and regulatory advertising provisions and relevant Health Canada guidance documents on advertising. This is to inform you that Health Canada has investigated the lnstagram posting by Ms. Kim Kardashian, of the drug Diclegis marketed as Diclectin in Canada by Duchesnay, Inc. (Duchesnay). 1. Social Media Advertising in the Canadian Regulatory Framework Section 2 of the Food and Drugs Act defines "advertisement " as any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food drug, cosmetic or device. This representation includes Instagram posts, as a form of social media communication , which is considered as one of the advertising means upon which all legislative and regulatory advertising provisions would apply. Canada•·• . . ./2 -2- 2. Contravention of Section C.01.044 of the Food and Drug Regulations (F&DR) Section C.0 1.044 of the F&DR restricts the advertising of a prescription drug to consumers to the mention of the name, price or quantity. Under this regulatory framework, Health Canada bas 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" . Although the drug involved in the post is Diclegis, Health Canada bas granted a Market Authorization of this drug under the brand name Diclectin, a prescription drug. We note as well that Duchesnay USA is the primary sponsor of the post; however, the implications of such advertising practices, including the reach of social media to Canadian consumers must be taken into consideration. Health Canada has conducted an assessment of the aforementioned Instagram post in the Canadian context and is of the view that it contravenes Section C.01.044 of the F&DR. The post at issue is of the Reminder ad type. However, statements included go far beyond the name, price , and quantity restrictions, as they include the indication of the drug along with the brand name and it misleadingly provides an endorsement of this drug, which may pose a risk to Canadians. 3. In Conclusion Health Canada has noted that Duchesnay has now removed this Instagram post but requests that it refrain from engaging in subsequent advertising practices of a similar nature. Please advise us within 15 business days from receipt of this letter on the steps Duchesnay will take to this effect. Should Duchesnay decide to engage in advertising of its product in Canada, Health Canada encourages it to take advantage of the independent Canadian advertising preclearance system: a voluntary, but valuable, resource to help health product manufacturers and advertisers develop promotional material which complies with the legislative and regulatory advertising provisions. Advertising Standards Canada (ASC) and the Pharmaceutical Advertising Advisory Board (PAAB) provide advisory opinions on consumer-directed messages for prescription drugs and Schedule D drugs (such as vaccines) with the objective that they meet the regulatory requirements . .. ./3 -3You may also wish to consul t Health Canada ' s Web site for more information about Canada ' s regulatory requiremen ts for healt h product advertising 1• A list of Canad ian advertising preclearance agencies is also available on our Web site2. Please feel free to contac t us should you require further clarifica tions. P:Iease be advised that all corresponde nce betw een Heahh Canada and Duchesnay on this issue mus t proceed through Alain Musen