Attorney General, DCP Commissioner Announce Oxycontin Maker Agrees To Halt Illegal Marketing

May 8, 2007

Attorney General Richard Blumenthal and Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr. today announced the maker of OxyContin has agreed to stop alleged illegal marketing of the drug and take additional steps against abuse and diversion.

The settlement also requires Purdue Pharma, LLC, of Stamford to pay Connecticut $719,500, part of $19.5 million it will pay Connecticut, 25 other states and the District of Columbia. Connecticut will allocate $100,000 from the settlement to help fund a state prescription drug monitoring system.

Under the settlement, Purdue Pharma agreed to stop "off label" marketing of OxyContin, a powerful time-released narcotic pain reliever. Doctors may prescribe drugs to treat illnesses and in ways not approved by the FDA - called "off-label" prescribing - but the FDA bans drug companies from marketing to encourage the practice.

Purdue Pharma allegedly violated FDA's rules by aggressively encouraging doctors to prescribe OxyContin for use every eight hours, instead of the 12 hours approved by the agency.

The settlement also resolves allegations that Purdue Pharma failed to fully disclose OxyContin's abuse and diversion risks. Crushing OxyContin destroys its time release feature, making it a sought-after street drug.

"Our message to drug manufacturers: off-label marketing is off limits," Blumenthal said. "We are raising the bar on off-label marketing - and other promotion tactics - that lead to abuse and diversion of prescription drugs.

"Effective prescription drug monitoring is much needed to assure that drug sales are watched in real time and real dollars as a safeguard against illegal sales and abuse. This settlement will help fund such drug monitoring," Blumenthal added.

"I am pleased with the outcome of this settlement and applaud the efforts of the Department of Consumer Protection and the Office of the Attorney General in seeing that Connecticut was well represented in this case," Gov. M. Jodi Rell said. "The availability of $100,000 to assist in creation of the state's prescription monitoring program is especially significant, allowing us to move ahead even more quickly on this state-of-the-art program that will literally save lives."

"This multi-state settlement is of enormous benefit to Connecticut citizens, in that the distribution of funds will greatly enhance our abilities in preventing illicit prescription drug trafficking and abuse," Farrell said. "The $100,000 allocation toward implementing the state's drug monitoring program will speed our progress to clamp down on a great deal of trafficking and abuse of prescription medications in Connecticut. The computerized program will allow us to track prescription patterns, identifying those persons who are getting multiple prescriptions for certain medications and either abusing the drug themselves or illegally selling it to others."

The settlement requires Purdue Pharma to:

• Market and promote OxyContin in a manner consistent with its package insert that does not minimize the drug's approved uses.
  
• Stop marketing or promoting OxyContin for off-label use.
  
• Maintain the internal abuse and diversion detection program the company established to detect problem prescribing and require the training of all field personnel in the program.
• Require recipients of Purdue Pharma grants or other remuneration to publicly disclose their acceptance of company funds.
  
• Neither sponsor nor fund educational events at which it knows a speaker will promote off-label use of OxyContin.
  
• Cease basing Purdue Pharma sales representative bonuses solely on the volume of OxyContin prescribed.
  
• Make sales representatives' effectiveness in explaining the potential for abuse or diversion of OxyContin part of their performance reviews.

In addition to the requirements to market and promote OxyContin only in accordance with FDA-approved uses, and formalizing the "OxyContin Abuse and Diversion Detection Program," the settlement prohibits Purdue from making any false, misleading or deceptive claim regarding OxyContin.

Also taking part in today's settlement are: Arizona, Arkansas, California, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin.

Of the remaining $619,500, the DCP's and the Attorney General's Office's consumer funds will receive $37,500 each. The remainder will go into the state's General Fund.

Attorney General's 2003 Citizen's Petition to FDA regarding off-label marketing of OxyContin