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GAO Recommends Drug Risk Management Plan
March 16, 2004

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Research Summary

Investigating congressional concerns about the narcotic painkiller OxyContin, the General Accounting Office (GAO) is recommending that pharmaceutical companies submit risk-management plans for controlled substances to the Food and Drug Administration (FDA), Alcoholism & Drug Abuse Weekly reported Feb. 2.

The GAO said the plan should contain strategies for identifying potential misuse problems that could arise. Among the factors the plan should address, the GAO said, are how drugs are marketed and promoted, what factors contribute to misuse and diversion, and what actions should be taken to address potential problems.

The GAO added that addressing misuse and diversion problems should be a combined effort by pharmaceutical makers, the federal and state agencies that oversee the approval and use of prescription drugs, healthcare providers who prescribe and dispense them, and law-enforcement officials.

Regarding OxyContin, the GAO investigation found that the company's aggressive marketing efforts, combined with misleading medical journal advertisements and a failure to prominently display warnings about the fatal risks of improperly using the drug, contributed to the drug's misuse.

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