FDA oversight of drug company promotion of off-label use is poor, US watchdog says

doi:10.1136/bmj.a1163

Published 5 August 2008, doi:10.1136/bmj.a1163
Cite this as: BMJ 2008;337:a1163

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FDA oversight of drug company promotion of off-label use is poor, US watchdog says

Janice Hopkins Tanne

¹ New York

The first 150 words of the full text of this article appear below.

The US Food and Drug Administration does a poor job of monitoringdrug companies’ promotion of unapproved or "off-label"uses of their drugs, says a report by the US Government AccountabilityOffice, the investigative arm of Congress.

Charles Grassley, an Iowa senator who is the senior Republicanmember of the Senate Committee on Finance, asked the accountabilityoffice to review the FDA’s effectiveness in monitoringdrug companies’ efforts to promote off-label uses. Hesaid he was concerned about the possible effects of such promotionon doctors’ prescribing practices and on patients’safety.

Although doctors may prescribe drugs off label for indicationsthat have not been approved by the FDA, drug companies are forbiddenfrom promoting such unapproved uses.

The accountability office’s report said the FDA’smonitoring system was disorganised and slow. It said that concernsabout promotion of off-label use had grown in recent years andcited a 2006 study . . . [Full text of this article]

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