By David Helwig
SooToday.com
Thursday, May 10, 2007

Purdue Pharma L.P., the company that makes OxyContin, and three of its former and current executives pleaded guilty today to misleading the public about the painkiller's addictive nature.

The drugmaker and its executives must pay a total of $634.5 million in fines.

Earlier this week, Purdue Pharma L.P. agreed to a $19.5 million payout to 26 states and the District of Columbia to resolve allegations that it encouraged overprescribing of OxyContin.

The following is an abridged version of a news release issued by the company today:

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Statement of Purdue Pharma regarding resolution of the federal investigation in the Western District of Virginia Stamford, CT

May 10, 2007 - Purdue Pharma L.P. today announced that it has resolved 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: “Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some healthcare professionals that were inconsistent with the FDA-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine.

"The statements also violated written company policies requiring adherence to the prescribing information. The misstatements were made prior to July 2001 and related to the risks of addiction, abuse, withdrawal, and tolerance compared to other pain medications.

"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. In July 2001, we added amplified warnings to the prescribing information and communicated those warnings to healthcare professionals."

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.

The professional product labeling for OxyContin Tablets contains the following boxed warning:

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.

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