Integris Mobile for Pharmaceutical Detailing
Put simply, the United States Food and Drug Administration (FDA) prohibits companies from marketing product (drugs, medical devices, etc.) for uses that the federal agency has not approved. Off-label promotion comes in two forms: marketing a product that has not received FDA approval; and promoting an approved product for an unapproved use. Off-label marketing can be seen as attractive because it results in increased profits given that companies don’t invest in further FDA approvals.
Controlling off-label promotion through enhanced compliance integrity. Off-label promotion can be explicit or implicit. “Explicit off-label” promotion occurs when a manufacturer makes direct claims about a product to promote it for an unapproved use while “Implicit off-label” promotion occurs when a manufacturer indirectly suggests that a device is appropriate for an unapproved use. Yet, violations of the False Claims Act can result in huge financial penalties from the Office of the Inspector General in the form of compliance integrity agreements (CIA) and the threat of having medicines taken off Medicare, Medicaid and other formularies could compound those financial penalties.
IntegrisMobile, IntegrisManager, and our IntegrisListener “plug-in” provide a complimentary audit & compliance suite to existing Closed Loop Marketing (CLM) solutions ensuring corporate governance and program integrity through real-time monitoring and archival of actual promotional marketing interactions.
- Improve Quality & Governance.
- Enable real-time training, monitoring and dynamic feedback for all market facing personnel.
- Enable real-time monitoring/auditing of promotional activities of sales force both internal and 3rd party contract sales.
- Deter the use of off-label promotional activities by ad-hoc or scheduled auditing of sales promotions.
- Record & Archive customer facing promotional activities for audit by internal or independent review organizations (IRO).