Statement of Purdue Pharma Regarding July 20 Proceedings in the United States District Court for the Western District of Virginia
STAMFORD, Conn., July 20, 2007 - Purdue Pharma L.P. today announced that United States District Court Chief Judge James P. Jones has accepted its settlement with the government to resolve a four-year investigation by the United States Attorney’s Office in the Western District of Virginia principally involving the promotion of OxyContin® (oxycodone HCl controlled-release) Tablets.
The company stated:
"Judge Jones’ acceptance of the settlement concludes this matter and we welcome its resolution.
More than six years ago, some employees violated our company’s written policy requiring that all communications to healthcare professionals about OxyContin adhere strictly to the FDA-approved prescribing information for this medicine and its express warnings about risks. We accept responsibility for those past misstatements and regret that they were made.
During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again. We also have added amplified warnings to the prescribing information for OxyContin and communicated those warnings to healthcare professionals. We have never marketed OxyContin directly to consumers, and we will never do so.
OxyContin is an important medicine developed for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. It has also, along with other prescription medicines, become a target of abuse. Prescription drug abuse – including abuse of OxyContin – has had tragic consequences for individuals and their loved ones. Although the government has not alleged in any document filed with the court that the misconduct of certain of our employees years ago caused OxyContin abuse, we have worked for years with the medical community and law enforcement to fight illegal trafficking of our and other prescription medicines. We will continue to do so."
OxyContin remains available by prescription from licensed healthcare professionals. Its FDA-approved indication for medical use has not changed as a result of this settlement. Purdue Pharma will continue to participate in federally-funded health programs and OxyContin will continue to be eligible for coverage by health care programs that use federal dollars, subject to the terms and conditions of the specific health care program in question.
Purdue Pharma L.P. is a research-based pharmaceutical company known for pioneering work on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. For years, Purdue has established innovative and effective programs to help physicians, pharmacists and law enforcement combat prescription drug abuse and diversion. Additional information about Purdue can be found at www.purduepharma.com. Program information is available at http://www.purduepharma.com/pressroom/app/news_announc/ss_10ptPlan.asp
The professional product labeling
for OxyContin® Tablets contains the
following boxed warning:
OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available at http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf.
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Timothy Bannon, (203) 588-8450
James Heins, (203) 588-8069
Posted: July 2007
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