Recently, Institute Biochimique got its “hand slapped” by the FDA because of its hypothyroid drug Tirosint’s Facebook page. The page was subsequently removed after the FDA concluded that the drug’s manufacturer omitted risk information about the inability of the drug to treat obesity and weight loss, as well as the drug not being suitable for children. The FDA has proved it’s watching: do you think it’s worth the risk for medical companies to engage in social media?
Examples like the Tirosint Facebook page, offer a possible explanation as to the reasons many medical device and pharmaceutical companies are resistant to integrating various streams of social media such as Facebook, blogs, and Twitter, due to the inherent risk posed by real-time engagement with potential patients. However, with the growing increase of social networking, directors of marketing are eagerly looking for an approach to manage engagement throughout the various channels of social media. The FDA’s recent draft guidance released in January of this year, attempts to narrow down the ambiguity over user-generated content (UGC).
Here are 8 tips to take the fear out of Promotional and User Generated Content based on the FDA Draft Guidelines:
1. When in doubt, Submit to FDA per Postmarketing Submission Requirements. The FDA says in the draft recommendations that it “recognizes the challenges of submitting promotional materials that display real-time information.” In recognizing this, a firm that follows the proper postmarketing submission requirements will receive, “enforcement discretion regarding the regulatory requirements for post marketing submissions related to promotional labeling and advertising.” A best practice for medical device and pharmaceutical marketing teams would be to maintain a habit of continually keeping the FDA informed by submitting your FDA 2253 or FDA 2301 and additional information as specified in part V.
2. Submit If You Place It, Manage, or Review Content. Product promotional messaging on Twitter, Facebook, or your company’s blog, for example, and other types of digital content you create and place in various social channels, come with the added responsibility for submitting this information to the FDA as required by postmarketing submission requirements. This also applies if your company is managing the material creation, editing it, or giving approval.
3. Submit If You Pay for a Third-Party Site. When your company pays, or has any kind of editorial influence over the material on a third-party site, then you must submit.
4. Don’t Submit If You Pay but Don’t Have Control. The example given by the January 2014 FDA Draft Guidelines is if your company pays for a third-party site “through an unrestricted educational grant” and your company has no access to control or manage the site, then you don’t have to submit content to meet post marketing submission requirements.
5. Don’t Submit UGC. If you don’t have control or influence the UGC on a site under your control, or there is UGC on a site you don’t control, you don’t have to submit.
6. Submit if You “Like”. If your company representative responds to UGC or “Like’s” something, then you will need to submit.
7. Submit if the Content Is Generated by Authorized Company Representative. Your company is responsible for any content created by those employees and sales reps promoting products for the firm, “A firm is responsible for the content generated by its employees or any agents acting on behalf of the firm who promote the firm’s product.”
8. Submit Content from Paid Bloggers. A paid blogger’s content would need to be submitted per FDA postmarketing submission requirements.