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Violations Prove Costly to Maker of OxyContin

An illegal scheme to promote, market and sell OxyContin will cost the maker of the powerful prescription pain reliever $600 million. That's how much The Purdue Frederick Company Inc has agreed to pay to resolve criminal charges and civil liabilities related to various unlawful practices.

In a case prosecuted by the U.S. Attorney's Office for the Western District of Virginia, FDA's Office of Criminal Investigations (OCI) uncovered an extensive, long-term scheme in which Purdue

• trained sales representatives to falsely represent to health care providers the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet
• trained its sales force to represent to health care providers that OxyContin didn't cause euphoria and was less addictive than immediate-release opiates
• allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine
• labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone"
• represented falsely that lower dosages of the drug can always be discontinued abruptly without patients suffering withdrawal symptoms or tolerance

"FDA will not tolerate practices that falsely promote drug products and place consumers at health risk," says Margaret O.K. Glavin, FDA's Associate Commissioner for Regulatory Affairs. "We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars."

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, more than $276 million in forfeiture, and a related civil settlement under which Purdue will pay $100.6 million to the United States.

In addition, three of Purdue's current and former executive employees pled guilty to a misdemeanor violation of misbranding OxyContin as being the responsible corporate officers during the long-term illegal promotion of the drug.

For more information about OxyContin, visit www.fda.gov/cder/drug/infopage/oxycontin/oxycontin-qa.htm.

Date Posted: May 21, 2007

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