Biopharmaceutical and Medical Device Compliance

April 2012Articles BioProcess International

Off-label marketing occurs when doctors prescribe a drug or device for a use that has not received FDA approval. Physicians have the unfettered right to prescribe the best drugs or devices for their patients, including approved drugs and devices for unapproved uses. Pharmaceutical and medical device manufacturers, however, cannot promote their products for such uses — even if those are supported in medical literature. Companies cross the line when their sales representatives sell physicians on the idea of using drugs for off-label purposes, sometimes with inducements and misrepresentations.

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