In only the second Untitled Letter of the year, FDA’s Office of Prescription Drug Promotion warned a Swiss drug company about statements the company made on its Facebook page. Notably, FDA became aware of the company’s Facebook promotion through its own monitoring and surveillance program.
The alleged violations themselves were straightforward and similar to more traditional advertising actions: failure to include risk information and omission of material facts. What makes this letter interesting is that the activity occurred on a social network. On its Facebook page, the company suggested consumers talk to their doctor if they have been diagnosed with the condition for which the drug at issue is indicated. Nowhere on the page did the company warn consumers about the risks associated with the product – risks serious enough to require a boxed warning on the label. Neither did the company include any discussion about limitations of the drug’s use. FDA requested the company immediately cease this promotional activity – and the company has complied. The Facebook page at issue is no longer active.
The takeaway here is to remember that FDA’s advertising and promotion rules apply regardless of how or where you promote your product. You must assume that all activity on social media networks, including Facebook and others, will be scrutinized by the FDA.