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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration To improve efforts to prevent or identify the abuse and diversion of schedule II controlled substances, the Commissioner of Food and Drugs should ensure that FDA's risk management plan guidance encourages pharmaceutical manufacturers that submit new drug applications for these substances to include plans that contain a strategy for monitoring the use of these drugs and identifying potential abuse and diversion problems.
Closed - Implemented
Consistent with GAO's recommendation, FDA issued guidance in March 2005 that recommends sponsors of schedule II controlled substances develop and use risk minimization action plans. Though FDA had approved one schedule II controlled substance since our recommendation and that application included a detailed risk minimization action plan, the manufacturer of this controlled substance subsequently provided FDA information showing abuse of the controlled substance and suspended sales and marketing of it.

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