In a June 18, 2014 Federal Register notice, the Food and Drug Administration (FDA) announced the availability of two documents providing draft guidance on industry use of internet and social media platforms with character space limitations and correction of third-party misinformation about prescription drugs and medical devices.
The first draft guidance document – Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices – encapsulates FDA’s current thinking on how the industry should use digital platforms with character space limitations, such as Twitter or sponsored links, to promote drugs or medical devices. When using such platforms, a company presenting information on the benefits of a product must also provide balanced risk information, including the most serious risks associated with the product and a link to more complete risk information. Companies should also communicate the indicated use and name (brand and established) of a product. If a company concludes that the required information cannot be communicated within the character space limitations, it should reconsider using the platform for the promotional message.
A second guidance document – Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices – advises how the industry should respond to product misinformation disseminated by independent third parties on the internet or social media regardless of whether that information appears on a company’s own forum or an independent forum or website. Misinformation is defined as “positive or negative incorrect representations or implications about a firm’s product.” The FDA guidance makes clear that the industry generally has no obligation to correct misinformation propagated by independent third parties. Should a company choose to correct faulty statements, however, it may provide truthful and non-misleading corrective information or, alternatively, a reputable source from which to obtain the correct information. A firm need not correct all misinformation on a forum, but must correct both positive and negative misinformation in a clearly defined portion of the forum it identifies.
FDA recommends that companies keep records of any corrections they make to assist in any questions that FDA might have. FDA is still working to finalize these guidance documents and has requested comments by September 16, 2014. While not ground breaking, these documents are useful in providing insight into FDA’s thinking and the attendant risks for companies engaging in online promotional and corrective activities.