DEA has expressed  concern that Purdue marketed OxyContin for a wide variety of conditions  to physicians who may not have been adequately trained in pain  management. Purdue has stated that by 2003 primary  care physicians had grown to constitute nearly half of all OxyContin  prescribers, based on data from IMS Health, an information service  providing pharmaceutical market research. 1.) In addition, the original label’s safety  warning advising patients not to crush the tablets because of the possible  rapid release of a potentially toxic amount of oxycodone may have  inadvertently alerted abusers to possible methods for misuse. Further, the  rapid growth in OxyContin sales increased the drug’s availability in the  marketplace and may have contributed to opportunities to obtain the drug  illicitly. However, we could  not assess the relationship between the growth in OxyContin prescriptions  or increased availability with the drug’s abuse and diversion because the  data on abuse and diversion are not reliable, comprehensive, or timely. OxyContin’s Formulation May Have Made It an Inviting Drug for Abuse and Diversion

While OxyContin’s potency and controlled-release feature may have made  the drug beneficial for the relief of moderate-to-severe pain over an  extended period of time, DEA has stated that those attributes of its  formulation have also made it an attractive target for abuse and diversion. According to recent studies, oxycodone, the active ingredient in  OxyContin, is twice as potent as morphine. History of Prescription Drug Abuse in Some States May Have Predisposed Them to Problems with OxyContin

According to DEA, the abuse and diversion of OxyContin in some states  may have reflected the geographic area’s history of prescription drug  abuse. Federal and State Agencies and Purdue Have Taken Actions to Prevent Abuse and Diversion of OxyContin

Since becoming aware of reports of abuse and diversion of OxyContin,  federal and state agencies and Purdue have taken actions intended to  address these problems. Purdue has initiated drug abuse and diversion education  programs, taken disciplinary actions against sales representatives who  improperly promote OxyContin, and referred physicians who were  suspected of improperly prescribing OxyContin to the appropriate  authorities. FDA has also taken other actions to address the abuse and diversion of  OxyContin. Purdue Is Implementing a Risk Management Plan for OxyContin

In response to concerns about abuse and diversion of OxyContin, in April  2001 FDA and Purdue began to discuss the development of a risk  management plan to help detect and prevent abuse and diversion of  OxyContin. Although risk  management plans were not in use when OxyContin was approved, they  are now an optional feature of new drug applications. FDA plans to  complete its guidance to the pharmaceutical industry on risk management  plans by September 30, 2004. We agree with DEA that Purdue conducted an  extensive campaign to market and promote OxyContin using an expanded  sales force and multiple promotional approaches to encourage physicians,  including primary care specialists, to prescribe OxyContin as an initial  opioid treatment for noncancer pain, and that these efforts may have  contributed to the problems with abuse and diversion by increasing the  availability of the drug in the marketplace.
Why GAO Did This Study

Amid heightened awareness that many patients with cancer and other chronic diseases suffer from undertreated pain, the Food and Drug Administration (FDA) approved Purdue Pharma's controlled-release pain reliever OxyContin in 1995. Sales grew rapidly, and by 2001 OxyContin had become the most prescribed brandname narcotic medication for treating moderate-to-severe pain. In early 2000, reports began to surface about abuse and diversion for illicit use of OxyContin, which contains the opioid oxycodone. GAO was asked to examine concerns about these issues. Specifically, GAO reviewed (1) how OxyContin was marketed and promoted, (2) what factors contributed to the abuse and diversion of OxyContin, and (3) what actions have been taken to address OxyContin abuse and diversion.

What GAO Found

Purdue conducted an extensive campaign to market and promote OxyContin using an expanded sales force to encourage physicians, including primary care specialists, to prescribe OxyContin not only for cancer pain but also as an initial opioid treatment for moderate-to-severe noncancer pain. OxyContin prescriptions, particularly those for noncancer pain, grew rapidly, and by 2003 nearly half of all OxyContin prescribers were primary care physicians. The Drug Enforcement Administration (DEA) has expressed concern that Purdue's aggressive marketing of OxyContin focused on promoting the drug to treat a wide range of conditions to physicians who may not have been adequately trained in pain management. FDA has taken two actions against Purdue for OxyContin advertising violations. Further, Purdue did not submit an OxyContin promotional video for FDA review upon its initial use in 1998, as required by FDA regulations. Several factors may have contributed to the abuse and diversion of OxyContin. The active ingredient in OxyContin is twice as potent as morphine, which may have made it an attractive target for misuse. Further, the original label's safety warning advising patients not to crush the tablets because of the possible rapid release of a potentially toxic amount of oxycodone may have inadvertently alerted abusers to methods for abuse. Moreover, the significant increase in OxyContin's availability in the marketplace may have increased opportunities to obtain the drug illicitly in some states. Finally, the history of abuse and diversion of prescription drugs, including opioids, in some states may have predisposed certain areas to problems with OxyContin. However, GAO could not assess the relationship between the increased availability of OxyContin and locations of abuse and diversion because the data on abuse and diversion are not reliable, comprehensive, or timely. Federal and state agencies and Purdue have taken actions to address the abuse and diversion of OxyContin. FDA approved a stronger safety warning on OxyContin's label. In addition, FDA and Purdue collaborated on a risk management plan to help detect and prevent OxyContin abuse and diversion, an approach that was not used at the time OxyContin was approved. FDA plans to provide guidance to the pharmaceutical industry by September 2004 on risk management plans, which are an optional feature of new drug applications. DEA has established a national action plan to prevent abuse and diversion of OxyContin. State agencies have investigated reports of abuse and diversion. In addition to developing a risk management plan, Purdue has initiated several OxyContin-related educational programs, taken disciplinary action against sales representatives who improperly promoted OxyContin, and referred physicians suspected of improper prescribing practices to the authorities.