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Capitol Health Call
September 17, 2008

FDA Enforcement Lags

JAMA. 2008;300(11):1290. doi:10.1001/jama.300.11.1290-d

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.