Pharmaceutical drugs sales, qui tam lawsuits
  And the False Claims Act -- Part II

Off-label marketing and qui tam lawsuits
Pharmaceutical companies may be liable under the False Claims Act if they promote the use of prescription drugs for unapproved (off-label) indications for Medicare patients. Providing physicians with drug marketing information that is misleading or false also may expose a pharmaceutical manufacturer to False Claims Act liability.

Federal regulations require drug companies to seek approval from the U.S. Food and Drug Administration to market drugs to doctors for particular illnesses. To get that approval, the drug companies must provide data proving that a drug is safe and effective for those illnesses. However, doctors still can prescribe drugs for unapproved uses if they believe those drugs would be helpful for a patient.

One of the most prominent qui tam cases involving off-label marketing by a pharmaceutical company was a qui tam lawsuit against Pfizer Inc. The drug manufacturer paid $430 million to settle qui tam allegations that Pfizer had marketed Neurontin, an anti-seizure medication, for unapproved uses.

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