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Off-Label and Unapproved Use

This archive displays posts tagged as relevant to off-label marketing and prescribing of pharmaceuticals and medical devices. You may also be interested in our pages:

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Stiff Amgen Fine Shows No Slowing Down in Government Prosecution of Off-Label Marketing

Posted  12/20/12
By Gordon Schnell It was only two weeks ago that the Second Circuit Court of Appeals came down with its groundbreaking decision in U.S. v. Caronia.  In a 2-to-1 ruling by a three-judge panel, the appeals court overturned the conviction of a drug company sales representative for promoting a prescription drug for uses not approved by the FDA.  The majority reasoned that banning such off-label marketing violated the...

The Fraud Behind the Fraud of Off-Label Drug Marketing

Posted  10/5/12
By Gordon Schnell It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label...
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