FDA has issued two draft guidance documents on the use of social media platforms for promoting benefit information and the correction of misinformation presented online. The guidance documents were issued as a result of public hearings held in 2009 at which industry, healthcare, and consumer groups provided FDA with comments on the promotion of regulated medical products using the Internet.
Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devicesdescribes how manufacturers, packers, and distributors of prescription drugs and medical devices should present both benefit and risk information within advertising and promotional labeling of their FDA-regulated medical products on electronic/digital platforms that are associated with character space limitations—specifically on the Internet and through social media or other technological venues (e.g., Twitter and search engines). The draft guidance illustrates FDA’s thinking on factors that are “relevant to the communication of benefit and risk information on Internet/social media platforms with character space limitations.”
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devicesdescribes how manufacturers, packers, and distributors of prescription drugs and medical devices should respond to misinformation related to a firm’s own FDA-approved or -cleared products created or disseminated by independent third parties on the Internet or through social media.