FDA Issues Draft Guidances Regarding Social Media: Handling Misinformation and Character Space Limits


On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (“Internet/Social Media: Correcting Misinformation Draft Guidance”) and Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (“Internet/Social Media: Character Limitations Draft Guidance”). The Office of Prescription Drug Promotion (OPDP) in the Center for DrugEvaluation and Research (CDER) prepared both draft guidances, in consultation with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Veterinary Medicine (CVM). Although the draft guidances do not present binding rules or requirements, they nevertheless provide critical insight into FDA’s views on social media communications. Written comments on the draft guidances are due by September 16, 2014.

Internet/Social Media: Correcting Misinformation Draft Guidance -

The Internet/Social Media: Correcting Misinformation DraftGuidance sets forth guidelines for when and how manufacturers, packers, and distributors (collectively, “firms”) can address incorrect information about their products that is disseminated by third parties on the internet or social media. If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in the draft guidance, FDA will not object if the corrective information otherwise does not satisfy FDA’s other labeling or advertising regulatory requirements.

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