Office of the Attorney General
Attorney General Greg Stumbo Announces Settlement with Purdue Pharma Over Labeling and Marketing of Oxycontin
Attorney General Greg Stumbo today announced a settlement with pharmaceutical maker Purdue Pharma regarding the narcotic pain medication OxyContin. The settlement resolves concerns that Purdue Pharma engaged in extensive off-label marketing of OxyContin, a time-released, Schedule II opioid used for pain management of moderate to severe pain over an extended period of time, and that Purdue Pharma failed to adequately disclose abuse and diversion risks associated with the drug in violation of Kentucky’s consumer protection statutes.
“Kentucky has suffered greatly from abuse of Oxycontin”, said Attorney General Stumbo. “Today we have a new tool to clamp down on illegitimate use of this drug. The court order outlaws dangerous practices at their source by controlling overprescribing and curbing aggressive sales by the manufacturer.”
Twenty-five states and the District of Columbia joined Kentucky in the settlement. A Consent Judgment has been tendered to the Franklin Circuit Court and is awaiting court approval. The Judgment includes strong injunctive relief which requires Purdue Pharma to maintain an abuse and diversion-detection program to detect and investigate problem prescribing, and requires all field personnel to undergo training on the program before being allowed to promote OxyContin.
The Judgment also requires Purdue Pharma to make available on a regular basis reports containing statistics as to the number of reports and investigations and a summary of the results; such reports will assist the state Attorneys General in identifying patterns of abuse or excessive prescribing by health care professionals. The settlement further requires Purdue to:
- 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 beyond the approved indications and uses of the drug;
- have any recipient of funds or other remuneration for grants publicly disclose the existence of that remuneration;
- not sponsor or fund any educational events where Purdue Pharma has knowledge at the time the decision for sponsorship or funding is made that a speaker will recommend the off-label use of OxyContin;
- not exclusively base Purdue Pharma sales representatives’ bonuses solely on the volume of OxyContin prescribed; and
- take into account in the performance evaluations of sales representative’s the effectiveness of the representative in educating prescribers about OxyContin and its potential for abuse and diversion.
In addition to the requirements to market and promote OxyContin only in line with FDA-approved uses, and formalizing the “OxyContin Abuse and Diversion Detection Program,” the proposed settlement prohibits Purdue Pharma from making any false, misleading or deceptive claim regarding OxyContin.
Finally, the settlement provides for a monetary payment by Purdue Pharma to the states in the amount of $19,500,000. Kentucky’s share of the settlement is $500,000.
“This is just the first step in holding the drug manufacturers accountable,” added Stumbo. “This settlement, combined with our ongoing law enforcement efforts, is helping to control Kentucky’s drug scourge.”
In addition to Kentucky, the following states took part in the investigation of Purdue Pharma’s business practices, as well as in today’s settlement: Arizona, Arkansas, California, Connecticut, Idaho, Illinois, 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.