Pre-Approval Statements and Representations by Pharmaceutical Manufacturers

This 90-minute webinar will help you understand the problems that can occur with statements by pharmaceutical manufacturers directed to off-label uses of pharmaceuticals.

Why Should You Attend:

Off-label uses cannot be legally promoted. Promoting off-label uses may be viewed by FDA as actionable under the False Claims Act. Criminal and civil liabilities can be substantial for manufacturers. One recent settlement agreement with FDA went into the hundreds of millions of dollars.

Areas Covered in the Seminar:

• How social media interactions can be handled.
• Contours of First Amendment freedom of speech protections.
• Promotion vs dissemination of information – types of communications.
• Solicited vs unsolicited information requests.
• Legally permitted limits on Commercial speech.
• Examples of recent cases dealing with communications about off-label uses of pharmaceuticals.

Who Will Benefit:

This webinar will provide valuable assistance to all pharmaceutical companies/ manufacturing sites.  Those that would benefit most would include:

• Marketing Directors / VP's
• Pharmaceutical Operations / Production Managers
• Pharmaceutical Marketing and Product Managers
• Legal department personnel