Purdue Pharma has agreed to pay $19.5 million to 26 states and Washington, D.C., to settle claims that the company promoted its painkiller OxyContin for off-label uses, the company announced on Tuesday, the Wall Street Journal reports (Wall Street Journal, 5/9). According to Connecticut Attorney General Richard Blumenthal and state Consumer Protection Commissioner Jerry Farrell, Purdue also allegedly violated FDA rules by promoting OxyContin for use every eight hours, rather than the approved dosage of every 12 hours (Hathaway, Hartford Courant, 5/9).

The states allege that Purdue violated FDA rules by promoting the drug as the painkiller "to start with and the one to stay with" for a variety of pain, including from surgery and broken bones, even though the drug was approved by FDA for limited use in people who need long-term pain management. In addition, the states allege that Purdue tied the pay of its sales representatives to how much OxyContin doctors prescribed, while playing down the addictive properties of the drug (Jadhav, St. Louis Post-Dispatch, 5/9). The cumulative effect of such practices has led to "misuse, diversion and abuse" of OxyContin by increasing the amount of the drug in circulation, according to Blumenthal.

Purdue denied the allegations of the lawsuit (Hartford Courant, 5/9). According to a statement from the company, OxyContin prescribing information "has always included clear warnings and precautions about abuse potential, addiction and other potentially adverse effects" (Bowman, Richmond Times-Dispatch, 5/9). The company added, "It has always been Purdue's written policy that promotion of its products must adhere to FDA-approved prescribing information for those products as well as applicable laws" (Eaton-Robb, AP/Greensboro News & Record, 5/8).

Settlement
Under the settlement, Purdue must halt off-label marketing practices, follow the warning label on its packaging and maintain an internal abuse-diversion detection program (Wall Street Journal, 5/9). The abuse-diversion detection program will include additional training for sales representatives on active monitoring of physicians' prescribing habits to prevent overprescribing (St. Louis Post-Dispatch, 5/9).

Each state can spend its portion of the settlement as it deems appropriate, which could include consumer protection, education and outreach programs, litigation, attorneys' fee or other uses, according to a statement from the Washington state Office of the Attorney General. The settlements do not establish a consumer refund program (Spokane Spokesman-Review, 5/9). North Carolina Attorney General Roy Cooper said, "Some medicines can do more harm than good when used the wrong way. Drug makers need to give doctors and patients accurate information about their drugs or expect to face the consequences" (AP/Greensboro News & Record, 5/8).

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View drug information on OxyContin.