Statement on the Withdrawal of Vioxx

DeLauro Statement on the Withdrawal of Vioxx

WASHINGTON - Last week, Merck & Co announced that after a very lengthy process it would permanently withdraw its arthritis medicine Vioxx from the market. This decision was made after Merck evaluated information showing a correlation between low doses of the drug among patients taking Vioxx for eighteen months and an increased rate of heart attacks and strokes. This decision, however, followed years of indications of safety problems with the drug at higher doses.

"I am very worried about the continuing evidence of mishandling of drug safety at the Food and Drug Administration (FDA). The FDA and the companies it is charged with regulating appear to have a very close relationship that may be impeding the ability of the Agency to credibly evaluate and regulate serious drug problems.

"I believe we need to reevaluate the relationship of user fees for paying for the evaluation of drugs, and determine whether appropriate steps are taken to reevaluate the drugs when they have initially been approved. It is time to look at re-organizing FDA to assure that the individuals being served are the patients of the United States who depend on the FDA to assure them that the medicines they take are safe."