FDA announces results of investigation into illegal promotion of OxyContin

May 11 2007

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has announced that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and by representing that "…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug." 

“FDA will not tolerate practices that falsely promote drug products and place consumers at health risk,” said Margaret O.K. Glavin, 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.”

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, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

In addition, Purdue's current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. 

This case was prosecuted by the U. S. Attorney's Office for the Western District of Virginia and investigated by FDA's Office of Criminal Investigations; the Internal Revenue Service's Criminal Investigations Division; the U.S. Department of Health and Human Services' Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.

http://www.fda.gov/