Warner-Lambert pleads guilty to off-label promotion
Compliance Monitor, June 15, 2004
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Pharmaceutical manufacturer Warner-Lambert June 7 pleaded guilty to criminal healthcare fraud charges and was sentenced to pay a $240 million fine for promoting its anti-seizure drug, Neurotonin, for unapproved use, otherwise known as "off-label" use.
It is the second-largest criminal fine ever imposed in a criminal healthcare prosecution.
A global agreement in May called for Warner-Lambert to pay more than $430 million to resolve criminal charges and civil liabilities.
According to the U.S. Department of Justice and the U.S. attorney's office in Massachusetts, where the trial was held, Warner-Lambert marketed the drug for a wide range of ailments for which it was not approved. It used several marketing tactics to accomplish its goal, including making false or misleading statements about its approval by the Food and Drug Administration for off-label use.
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