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Promoting off-label uses of drugs can be problematic for drugmakers

Pharmacy Regulation Resource, December 23, 2003

Drugmakers who promote off-label uses of their products could be asking for trouble, according to Drug Industry Daily (DID). Kenneth Nolan, an expert in healthcare litigation told DID that doing so could alert government regulators or leave the company open to potential litigation. "It's nice [from the whistle-blowers point of view] if the drug or drugs at issue are being marketed for unlabeled uses and we can establish that those uses are of questionable efficacy," Nolan told DID. "If you have that efficacy issue, or lack thereof, based on active marketing of unlabeled uses, it adds more fuel to the fire...and those types of situations are out there, unfortunately." He told DID, however, that he did not agree with the idea that marketing off-label uses results in an automatic False Claims Act violation.

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