Off-Label Information Dissemination Webinar

In recent years, the pharmaceutical industry has seen a surge in investigations of companies for allegedly engaging in off-label promotion of products. While litigation is on the rise, confusion surrounding offlabel information is mounting as well. The laws and guidelines are often ambiguous, and companies face many challenges in interpreting and applying the rules. In addition, with the emergence of social media and increasingly utilized electronic forms of communication, uncertainty and risk regarding the “do’s and don’ts” of off-label information sharing are growing. The consequences of noncompliance are real and severe, as the FDA can impose significant penalties in its enforcement actions and harsh terms in its CIOs.

Topics to be Discussed:

• Gain insight into the legal and regulatory landscape of off-label information dissemination with an overview of the FDA, OIG, US Attorney’s Office and individual state rules
• Review the difference between scientific exchange of information versus promotion
• Minimize risk in the activities of sales representatives, medical science liaisons, marketers and others who engage in medical communications
• Understand the challenges of non-traditional media and the corresponding rules of promotion
• Analyze case studies of compliant and noncompliant off-label information communication
• Examine the situations in which off-label information sharing is acceptable and how to engage most effectively