Report: GAO believes FDA yet to make safety changes after Vioxx scandal

WASHINGTON Despite a recommendation for restructuring three years ago following a prescription painkiller scandal, the Food and Drug Administration still hasn’t made the changes, according to published reports.

The Associated Press reported Wednesday that congressional investigators had recommended changes to the agency staff structure in 2006 to better monitor drug safety in the wake of the scandal surrounding Merck & Co.’s drug Vioxx (rofecoxib). The FDA had approved the drug in 1999, but it was pulled from the market in 2004 after several cases of heart attack and stroke among patients taking it.

Changes that the General Accounting Office and others have recommended in the past have included giving the FDA’s Office of Surveillance and Epidemiology the same ability to monitor drug safety as the Office of New Drugs.