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.
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.
Social media increases the chance for interaction between pharmaceutical manufacturers and patients (and others) like never before. Manufacturers are increasing in a position to responding to unsolicited requests for off-label information about prescription drugs and medical devices. The Federal Courts have offered some protections via interpretations of the First Amendment right to free speech.
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