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“Off-Label” use is a practice of prescribing drugs for uses other than those approved by the Food and Drug Administration (FDA). Once a prescription drug has been FDA approved, the FDA does not regulate how a physician uses the drug for the treatment of their patients.

The practice of “Off-Label” prescribing is very common in the United States and around the world. Upwards of one-fifth of all drugs are prescribed for uses other than the original purpose of the drug. For psychiatric drugs, the level rises above 30%.

However, this practice has lead to the miss-use of potent painkillers such as Actiq. Manufactured by Cephalon, Actiq is used when the patient develops a tolerance to other opioid pain medication. If used withing 14 days of other drugs or if the patient over-doses, life-threatening side effects can occur. In fact, Actiq was prescribed to patients who did not have a tolerance to opiates.

The drug manufacturer, Cephalon, agreed to pay $375 million global settlement with the U.S. Department of Justice in order to settle claims brought under the False Claims Act by the Medicare and Medicaid trust funds.

The action also included abuses of the drugs Gabitril and Provigil. Gabitirl was approved only for epilepsy, and ended up being prescribed as an anti-anxiety drug. Provigil was approved to treat daytime sleepiness associated with narcolepsy, sleep apnea, and shift work sleep disorder. Cephalon disregarded a 2002 FDA order not to market Provigil for its off-label use as a non-stimulant drug for sleepiness, fatigue, lack of energy, and decreased activity.

Cephalon plead guilty to the misdemeanor charge of distribution of misbranded drugs and agreed to pay $50 million in fines and forfeiture. $46.4 million was awarded to the four whistleblowers. A whistleblower is someone who reports misconduct at his or her place of employment. A famous whistleblower in recent history is Jeffery Wigand. He exposed the Big Tobacco scandal and was portrayed by Russell Crowe in the 1999 film The Insider.

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