January 16, 2014

FDA Issues Draft Guidance Addressing Aspect of Social Media Use in Prescription Drug Product Promotion

Summary: On January 13, 2014, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued Draft Guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” Despite its title and ostensible focus on postmarketing submissions, the guidance also sheds light on other critical issues – including the extent of a pharmaceutical manufacturer’s responsibility for content on third-party websites and user generated content on a company’s own website – that help open the door to greater use of interactive social media by pharmaceutical companies. 

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