False Promotion of OxyContin Costs Purdue Frederick $600 Million

Yael Waknine

May 11, 2007

May 11, 2007 — Purdue Frederick Company, Inc, has pled guilty to a felony count of misbranding oxycodone HCl extended-release tablets ( OxyContin) with the intent to defraud and mislead, the US Food and Drug Administration (FDA) announced yesterday.

The company had been training its sales force to falsely promote the opioid analgesic as less likely than other pain medications to cause abuse, addiction
, tolerance, and withdrawal, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

In particular, healthcare providers were deliberately misinformed that the extended-release formulation rendered oxycodone extraction more difficult and therefore decreased the potential for abuse, and that a lack of euphoria rendered it less addictive than immediate-release opiates or even morphine
. The delayed absorption and reduced fluctuation in plasma levels associated with the formulation were also suggested to reduce its abuse liability compared with immediate-release oxycodone.

"FDA will not tolerate practices that falsely promote drug products and place consumers at health risk," Margaret O. K. Glavin, associate commissioner for regulatory affairs, says in an FDA news release. "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 healthcare dollars."

Resolving the charges will cost the company more than $700 million, including $600 million to cover the criminal fine, restitution to government agencies, and more than $276 million in forfeiture; a $100.6 million civil settlement must also be paid to the United States.

Extended-release oxycodone is an opioid analgesic indicated for the management of moderate to severe pain in patients requiring continuous, around-the-clock analgesia for an extended period of time.

Healthcare professionals are encouraged to report adverse events potentially related to oxycodone to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch
, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 

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