The following presentation was delivered at e-Patient Connections 2010 Join the community at http://KruResearch.com/subscribe
FDA Part 15 Public Hearing on Internet and Social Media Promotion of FDA-Regulated Medical Products Barbara Chong, Pharm.D., BCPS Team Leader, Training and Support Division of Drug Marketing, Advertising, and Communications Center for Drug Evaluation and Research Food and Drug Administration
To protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.
This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.
How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?