Both in the U.S. and in Canada, advertising of prescription pharmaceutical products is highly regulated and can raise various challenges, which are heightened in the context of social media. The reason prescription pharmaceutical product ads are so widely found on American television is simple: the Unites States, along with New Zealand, are the only two countries to allow direct broadcasting of such advertisements to the general public (Direct-to-consumer/DTC advertising). On the other end of the spectrum, Canadian law prohibits all direct-to-consumer ads for narcotics or controlled drugs. As for prescription drug advertisements, they are limited to displaying only certain statutorily prescribed information. However, since these regulations were developed in the context of traditional media, applying them is proving more complicated in the era of social networks, whether in Canada or in the U.S. Restrictions on the number of characters, for example, can be quite mind-boggling when attempting to present all of the potential side effects associated with a drug!1
In Canada, pharmaceutical product advertisement is mainly regulated by the Food and Drugs Act (the “Canadian Act”). The basic rule of the Canadian Act states that no person shall advertise any drug in a manner that is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Although direct-to-consumer advertising of prescription drugs is allowed, the Canadian Act prohibits anyone from presenting such drugs to the general public as being a treatment, preventative measure or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. Schedule A lists a wide range of medical conditions, from chronic anxiety to congestive heart failure. Further, a prescription drug advertisement must limit itself to presenting information that is statutorily prescribed, such as the brand name, common name, true name, price and quantity of the drug. These rules are less stringent in certain regards, particularly with respect to biologic drugs and over-the-counter drugs, but that is largely beyond the scope of this article. Also of note, the Canadian Act does not prohibit the broadcast of informational messages pertaining to a particular drug when such messages do not set out the product benefits or use. In fact, insofar as they are not associated with a medical condition referred to in Schedule A, such messages (or help-seeking advertisements) are theoretically allowed.
Although it is clear that the above regulations apply to all forms of advertisement, no matter the broadcasting medium used, applying these rules to new media platforms is causing some confusion. In the recent years, Advertising Standards Canada (ASC), the national not-for-profit advertising self-regulatory body, released a short checklist on the advertising of drugs directly to the general public in which it simply reminded companies that all advertisements, even when broadcasted on social networks, must include the information required under the Canadian Act.
In the U.S., pharmaceutical product advertisement is mainly regulated by the Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act (the “US Act”). The great importance attached to the constitutional protection of freedom of expression is one of the main reasons direct-to-consumer advertising of pharmaceutical products is authorized, but advertising agencies are not granted blanket authority with this regard. Print ads, in addition to being truthful and non-misleading, must mandatorily contain certain information, including: i) the established name and commercial name of the drug; ii) their ingredients and quantities; and iii) a brief description of the side effects, contraindications and effectiveness associated with using the drug. There must also be a proper balance in the way the side effects, contraindications and effectiveness are presented. As for television and radio ads, the US Act provides that they may include only a brief disclosure of the main risks associated with the drug, as long as such ads provide a toll-free number that consumers may call to get full disclosure of this information.
In respect of social media, in its guidelines issued in June of 2014, the FDA advised that a company deciding to present the benefits of a certain drug must also make sure to set out the risks associated with that drug, no matter what limitations may be imposed by a social media platform with regards to the number of characters. The FDA also urged companies to provide consumers access to more detailed information about the risks associated with using the product (by providing a link to a more detailed website, for example).
As shown above, the rules related to the advertising of pharmaceutical products in Canada vary considerably from the rules applicable in the U.S. However, considering the free flow of information on social networks and the speed at which it travels on these platforms, messages originating in the U.S. will inevitably end up on Canadian consumers’ home pages. Although this spillover may be concerning, considering the more permissive nature of the U.S. rules, it is currently not monitored. Health Canada has stated that it has no jurisdiction over messages originating from the U.S., whether these messages are transmitted via traditional or new media.
In the absence of any specific rules applicable to drug advertising in the context of social media, pharmaceutical companies wishing to advertising their products on the various new platforms must rely on general advertising rules and make sure to apply them integrally. A good practice would be to closely monitor any further guidance on this topic provided by Health Canada and the FDA. We will keep you updated on future developments.
1 Let us first note that this article focuses on product claim ads (as opposed to reminder ads, for example, which make no reference to a drug’s effectiveness).