Knowledge base

Off-label drug promotion

A drug that has been tested and FDA-approved for one use but prescribed by a physician for another use, is known as “off-label.” Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. If the manufacturer promotes the drug for new uses in addition to than those already approved, and the additional use(s) are not supported by scientific evidence, and hence not supported by a citation in any applicable Compendia, then the drug manufacturer may be liable for a violation of the False Claims Act assuming other conditions are met.

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