Responding to questions on off-label uses of medical devices and drugs without breaking the US rules on promotion

摘要

As GlaxoSmithKline's recent $3 billion settlement with the US government illustrates, the intersection of permissible off-label use of medications or medical devices by physicians with the impermissible promotion by a manufacturer of its drug or device for an off-label purpose presents challenges for companies.While the Food and Drug Administration has recognised that "off-label use or treatment regimens may be important therapeutic options and may even constitute a medically recognised standard of care", manufacturers are prohibited from promoting their products for uses that are not approved uses as stated in the medication or device labelling.