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Mike Mitka

JAMA. 2008;300(11):1290.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

A Government Accountability Office (GAO) report issued July 28 found the Food and Drug Administration (FDA) to be slow in reacting to pharmaceutical manufacturers' impermissible promotions of off-label drug use.

The report (http://www.gao.gov/new.items/d08835.pdf) looked at the years 2003 through 2007 and found that the FDA issued 42 regulatory letters asking drug companies to stop off-label promotion. The FDA took an average of 7 months to issue these letters from the time they were first drafted. In addition, companies cited for more serious violations took an average of 4 months to take the corrective actions requested.

The GAO also found that the FDA did not refer any of these violations to the Department of Justice for enforcement action. During this period, the Justice Department, acting on violations identified by sources other than the FDA, settled 11 civil and criminal cases involving, at least partially, off-label promotion.

The . . . [Full Text of this Article]

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