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"Off-label" drug use and pre-emption

Despite perennial hints from some quarters that off-label use of prescription drugs or medical devices is somehow subterranean or illicit, it's in fact a perfectly recognized and appropriate thing for doctors to do across much of medical practice, and there's no reason why off-label use should ordinarily deprive drugmakers of an otherwise available preemption defense, argue Beck & Herrmann.

P.S. In a second post, they discuss the current vogue for entrepreneurial qui tam lawsuits demanding vast sums to compensate for moneys states laid out for off-label uses of drugs -- and never mind that the uses may in fact have been medically beneficial to patients.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.