ROCKVILLE, Md. -- The maker of oxycodone controlled-release tablets (OxyContin) has agreed to pay million in fines and civil penalties to resolve charges regarding the company's promotion of the drug as a less addictive pain-killer.
ROCKVILLE, Md., May 14 -- The maker of oxycodone controlled-release tablets (OxyContin) has agreed to pay million in fines and civil penalties to resolve charges regarding the company's promotion of the drug as a less addictive pain-killer.
As part of the settlement, the FDA said, Purdue pleaded guilty to a felony count of misbranding a drug with intent to defraud and mislead.
The settlement follows an investigation of the Purdue Frederick Company by the FDA's Office of Criminal Investigations.
The FDA said that the investigation uncovered evidence that Purdue Frederick attempted to maximize revenues from the sale of the drug through illegal means. Those included training its sales representatives "to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allow[ing] health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine."
In addition, the FDA said, Purdue falsely labeled the drug 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."
Margaret O.K. Glavin, FDA's associate commissioner for regulatory affairs, said the agency "will not tolerate practices that falsely promote drug products and place consumers at health risk."
The million settlement includes a criminal fine, restitution to government agencies, and more than million in forfeitures.
In addition, Purdue's current and former executives, Michael Friedman, Howard Udell, and Paul Goldenheim, M.D., pleaded 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.