Drug maker to pay states $19.5 million over painkiller advertising
Release date: 5/8/2007
AG Cooper and 26 other state AGs reach settlement with Purdue Pharma for pain drug OxyContin
Raleigh: A major drug company will pay North Carolina and 26 other states $19.5 million for marketing its pain drug OxyContin for off-label use and for failing to adequately disclose the drug’s potential for abuse and addiction, Attorney General Roy Cooper said today.
“Some medicines can do more harm than good when used the wrong way,” said Cooper. “Drug makers need to give doctors and patients accurate information about their drugs or expect to face the consequences.”
Purdue Pharma, maker of OxyContin, will pay the states $19.5 million including $715,900 to North Carolina. Purdue has also agreed not to make false, misleading or deceptive statements about OxyContin and to make a number of changes in the way it markets and promotes the popular painkiller for off-label use. Off-label use is the practice of prescribing drugs for uses that have not been approved by the US Food and Drug Administration.
OxyContin is a time-released prescription drug approved for treating long-term moderate to severe pain. According to the US Drug Enforcement Agency, OxyContin is a Schedule II narcotic that is often abused for non-medical purposes. The NC State Bureau of Investigation has investigated 10 cases so far this year involving the illegal diversion and misuse of OxyContin by healthcare professionals, and 31 North Carolina counties have above-average rates of prescribing OxyContin according to the DEA.
Among the requirements in North Carolina’s settlement, approved today by Wake County Superior Court
Judge Howard E. Manning, Jr., are provisions that Purdue must:
Market and promote OxyContin for approved uses rather than for off-label purposes;
Not misrepresent medical or scientific evidence about off-label use of OxyContin;
Provide fair and accurate information about OxyContin’s potential for abuse, addiction, or physical dependence, and not misrepresent that OxyContin is “nonaddictive” or “virtually nonaddictive;”
Establish a program to identify potential abuse or diversion of OxyContin that requires Purdue sales representatives and other employees to report suspicious prescribing of the drug;
Stop basing Purdue sales representatives’ bonuses solely on the amount of OxyContin prescribed; and
Require all sales representatives to undergo training on abuse and diversion before being allowed to promote OxyContin.
Other states taking part in the investigation of Purdue’s business practices and today’s settlement are: Arizona, Arkansas, California, Connecticut, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.