Preparing for the arrival of "pink Viagra": strengthening Canadian direct-to-consumer information regulations.

©2016 8872147 Canada Inc. or its licensors CMAJ, March 15, 2016, 188(5) 319 Do you remember the advertisement with a cartoon elephant lying in bed between a man and a woman, implying a huge problem in the bedroom? This was the beginning of a direct-toconsumer information campaign about erectile dysfunction. Called “40over40,” the campaign was sponsored by Eli Lilly, the manufacturer of Cialis (tadalafil). The popular media focus on male sexual performance has changed following the US Food and Drug Administration’s (FDA’s) recent approval of flibanserin (Addyi) for the treatment of acquired, generalized hypoactive sexual desire disorder in women premenopause.1 Often called “Viagra for women” or “pink Viagra,” flibanserin was twice not approved by the FDA in the past five years.2 The initial producer, Boehringer Ingelheim, transferred the rights to flibanserin to Sprout Pharmaceuticals in 2011, and rights were again recently transferred to the Canadian company Valeant Pharmaceuticals. We can expect that an application to Health Canada will be filed soon given the recent FDA approval. If the drug is approved in Canada, Valeant will not be able to promote flibanserin using direct-to-consumer advertisements, which are permitted in the United States but prohibited under Canadian law. However, it is legal for a company to “inform” consumers about a drug through direct-to-consumer information campaigns. These campaigns, such as the one by Eli Lilly, are aimed at