Press Release
For Immediate Release
May 8, 2007
 
Contact: Robyn Ziegler
312-814-3118
877-844-5461 (TTY)
rziegler@atg.state.il.us
 

ATTORNEY GENERAL MADIGAN REACHES AGREEMENT WITH PHARMACETUTICAL COMPANY OVER ITS PROMOTION OF PAIN RELIEVER OXYCONTIN

Springfield – Attorney General Lisa Madigan, along with 26 other attorneys general, today filed a lawsuit and entered into a settlement agreement with Purdue Pharma, L.P., requiring the pharmaceutical company to significantly alter and restrict its practices in promoting the drug, OxyContin, and to pay $19.5 million to the states involved.

The settlement resolves allegations that Purdue marketed OxyContin for use beyond the FDA-approved uses and that Purdue failed to adequately disclose abuse and diversion risks associated with the drug in violation of consumer protection laws.  OxyContin is a time-released, Schedule II opioid approved by the Food and Drug Administration (FDA) for use for pain management of moderate to severe pain over an extended period of time.

“We are concerned about the abuse of prescription drugs and this case raised very serious allegations, along with concerns that young people are particularly frequently abusing this drug,” Madigan said.  “With this settlement, we have focused on requiring Purdue to take all measures necessary to protect people from abusing OxyContin, especially young people.  We are pleased with the efforts that Purdue has committed to undertake to track and stop this abuse.” 

The FDA approved OxyContin for use in 1995.  At that time, OxyContin was uniquely placed in the pain medication market as a “time-released” drug that could provide for the release of medication, and the relief of pain over a longer period of time.  Shortly after its release, it was discovered that individuals were bypassing the safety aspect of the pill form of OxyContin by crushing the medication, which defeated the time-release feature and led to a high rate of abuse.

The settlement addresses marketing practices that Madigan and the other attorneys general believed were excessive or abusive, including alleged off-label marketing. 
Significantly, the settlement mandates that Purdue maintain an abuse and diversion-detection program that the company established to detect problem prescribing.  The settlement also requires that all Purdue field personnel must undergo training on the abuse and diversion-detection program before being allowed to promote OxyContin. 

The settlement also requires that Purdue must:

  • market and promote OxyContin in a manner consistent with its package insert and not in a manner that minimizes the approved uses for the drug; 

  • not market or promote OxyContin for off-label purposes – those purposes beyond the FDA-approved indications and uses of the drug;

  • require any recipient of Purdue funding to publicly disclose the existence of that funding or remuneration;

  • refrain from sponsoring or funding any educational events at which the speaker will recommend the off-label use of OxyContin;

  • make sure that the bonuses paid to Purdue sales representatives are not based solely on the volume of OxyContin prescribed; and

  • make sure that prescriber education about OxyContin and its potential for abuse and diversion is a component of the evaluations of Purdue sales representatives.

In addition to requiring that Purdue restrict its marketing and promotion of OxyContin to be strictly in line with FDA-approved uses and maintain and formalize its “OxyContin Abuse and Diversion Detection Program,” the settlement prohibits Purdue from making any false, misleading or deceptive claims regarding OxyContin.

In its 2007 Illinois Fact Sheet, the Drug Enforcement Administration recognized OxyContin as a highly abused substance in Illinois and noted that diversion of OxyContin continues to be a problem in this state. 

OxyContin abuse is a particular problem with teenagers.  According to a 2006 survey by the National Institute on Drug Abuse, OxyContin use outside of the use prescribed by a physician increased steadily among 12th graders from 2002 to 2005, with the number of students who admitted taking OxyContin in the last year rising from 4.0% to 5.5% of those surveyed.  In 2006, there was a slight decline to 4.3% of those surveyed.  Unfortunately during this same period, younger students that had not previously shown much increase in OxyContin use indicated increased usage, with 2.6% of 8th graders and 3.8% of 10th graders surveyed reporting that they had used OxyContin in the last year. 

The settlement requires Purdue to pay $19.5 million to the states.  Illinois’s share of this payment is $719,500 and will be used to fund consumer education and enforcement in the state.

Attorney General Madigan was joined in the investigation of Purdue’s business practices, as well as in today’s settlement, by the following states: Arizona, Arkansas, California, Connecticut,  Idaho, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.

Assistant Attorney General Cassandra Karimi handled this case for Madigan’s Consumer Fraud Bureau.

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