Until earlier this year, most drug manufacturers had been operating under the same policy relating to the use of sponsored links on search engines as had advertisers for other categories of products. That is, claims are made without disclosure on the search engine result page, driving consumers to a website where any required disclosures are made. The industry was shocked when FDA sent out 14 warning letters in a single day objecting to use of sponsored links without full compliance with FDA regulations. The letters effectively put an end to use of sponsored links for Rx products, at least for the time being, and also raised serious questions about online advertising generally. The industry is struggling to understand how FDA regulations and guidance documents affect various forms of online advertising. Guidance from FDA addressing the medium is long overdue.
FDA has already acknowledged the differences between media in promulgating regulations and issuing guidance documents. For example, FDA allows broadcast ads to contain a reference to the adequate provision of dissemination of approved package labeling instead of a full brief summary. It is time for FDA to do what FTC did long ago and acknowledge the idiosyncrasies of the internet.
The FTC has issued documents dedicated to online advertising, acknowledging that the same rules apply but offering guidance as to how to comply. For example, FTC sets out with adequate specificity how to make “clear and conspicuous” disclosures online. FDA wouldn't need to start from scratch, but could simply adapt FTC guidance. Doing so would provide much needed clarity to the industry. Tiffany Towers is a New York-based attorney in the advertising, marketing and promotions practice at Davis & Gilbert