FDA's Growing Role Regulating Health 2.0, Health IT

[Commentary] The Food and Drug Administration likely will play an increasingly important role in regulating health information technology. A hearing, "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools," set for mid-November is intended to help guide FDA in making policy decisions on how the Internet and social media tools (e.g., blogs, microblogs, podcasts, social networking sites, online communications, video sharing, widgets, and wikis) can be used to promote FDA-regulated medical products -- including human and animal drugs and biologics, and medical devices -- in a truthful, non-misleading, and balanced manner. Specific questions that will be addressed at the meeting include: For what online communications will manufacturers, packers or distributors be held accountable? How can manufacturers, packers and distributors fulfill regulatory requirements (e.g., fair balance) in their Internet and social network promotions? What parameters should apply to the posting of corrective information on Web sites controlled by third parties? When is the use of links appropriate? In addition, FDA is seeking public comment on Internet adverse event reporting.