Corporate Compliance

Purdue, execs plead guilty to misbranding OxyContin, agree to $634.5M fine

Compliance Monitor, May 16, 2007

Purdue Pharma and its president, chief legal officer, and former chief medical officer pleaded guilty last week to misbranding OxyContin, the company's highly addictive painkiller, according to the Department of Justice (DOJ). In addition to the guilty pleas, the company and the executives will pay $634.5 million in fines, including $160 million to cover false claims liability.

Purdue and the three executives pleaded guilty to fraudulently claiming that OxyContin was less addictive and less subject to abuse than it actually is. They also fraudulently claimed that the drug was less likely to cause withdrawal symptoms than other pain medications, although the company had no scientific evidence to support those claims and no FDA approval to make them.

The guilty plea follows a $19.5 million settlement with 26 states and the District of Columbia to settle claims that Purdue encouraged physicians to overprescribe OxyContin, reports the Associated Press.

According to the DOJ, the misbranding scheme involved several components, including:

  • Sales representatives falsely telling health care providers that OxyContin had less euphoric effect and less abuse potential than short-acting opioids

  • Supervisors and employees sponsoring sales training that exaggerated the differences between the blood plasma levels of OxyContin as compared to immediate-release opioids

  • Distributing an article about a study for sales representatives to use in promotions, although Purdue knew much of the study information was disputed

    To read more about the settlement and guilty plea, visit the DOJ Web site.

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