Unsolicited Requests From Companies Conducting Products Evaluation/Formulary Placement

December 1, 2012Articles FDLI Update

Recent fines by the federal government for off-label marketing highlight the critical regulatory and legal environment that pharmaceutical and medical device manufacturers continue to face. Off-label use is the practice of prescribing pharmaceuticals or using medical devices for an indication or intended use in an age group, dose or dosing schedule, duration of use or route of administration not contained in the approved product labeling (i.e., package insert [PI]). While it is considered lawful for a physician to independently decide to prescribe a drug or use a medical device for off-label indications when in the best interest of a patient, it is illegal for manufacturers to promote off-label uses of their products or devices.

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