FDA Investigating Illegal Promotion of OxyContin

Christina Cole

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The Purdue Frederick Company, Inc. has agreed to pay over $600 million to resolve criminal charges and civil liabilities regarding a long-term of illegal schemes to promote, market and sell OxyContin, a prescription pain reliever produced by them, announced the U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI).

In an extensive investigation conducted by OCI they discovered a long-term scheme to generate the maximum amount of revenues from sales of OxyContin. To help reach this goal, Purdue trained their sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient in OxyContin. They were also trained to tell health care providers that OxyContin didn't cause euphoria and was less addictive than immediate release opiates. Leading providers to believe OxyContin was less addictive than morphine.

In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and falsely represented that patients taking lower dosages of the drug can always be discontinued abruptly without suffering withdrawal symptoms or tolerance.

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, over $276 million in forfeiture, and a related civil settlement under which Purdue will pay $100.6 million to the United States.

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