The FDA Facebook Feeding Frenzy

Although the average Facebook user may succeed in ignoring the multitude of advertisements scattered throughout the page, the Food and Drug Administration wants drug marketers to know they are paying attention.  In a recent letter, an FDA regulatory review officer informed a pharmaceutical company, Akrimax that their Facebook webpage was in violation of the Federal Food, Drug, and Cosmetic Act.  The FDA deemed the Facebook page to be misleading “because it makes representations about the efficacy of [one of the company’s drugs] but fails to communicate any of the risks associate with its use.” This letter comes on the coattails of another FDA publication explaining marketing requirements for any media “owned, controlled, created, influenced or operated by, on, or on behalf of” a pharmaceutical firm.  In other words, the FDA recently made it clear that they expect firms to meet the same standards firms have grown accustomed to with more traditional media.

The FDA recently made it clear that they expect firms to meet the same standards firms have grown accustomed to with more traditional media.

The standard set forth by the FDA is thus familiar for both pharmaceutical marketing execs and the general populous that hears the risks and side-effects of drugs during nearly every television commercial break.  However, new media forms also present new challenges.  The FDA has made it clear that companies will be held responsible for any content generated by an agent or employee.  The expectation is that every advertisement (or post) needs to provide a “fair balance of the risks and benefits of a drug product and complete disclosure of the products approved indications for use.”  The new platforms of Facebook and Twitter thus present greater challenges than print or airway advertising.  Although word limits are not foreign to print media, few advertisements are 140 characters like Twitter (perhaps this is why drug companies don’t advertise with billboards).  Similarly, firms are accustomed to agency law, but the risk of an FDA violation committed by an employee using a smartphone to make a Facebook post adds another dimension of challenges in FDA compliance.

Nonetheless, it is assuring to know the FDA is keeping up with the times.   In a society evermore dependent on social media, advertising has certainly shifted in that direction.  If users need to be fully informed of the risks of drugs while passively viewing an advertisement on television, someone actively visiting a drug company’s webpage should accorded at least the same protection.  Thus, it will be important for the FDA to remain active in policing social media as marketers continue to explore new social media marketing techniques.  Based on the ease of social media updates, it is likely that a letter like this will make a large difference in assuring proper information is presented to potential users.