WASHINGTON - Congresswoman Rosa L. DeLauro (Conn.-3), a member of the House Committee on Appropriations Agriculture Subcommittee, today issued the following statement in response to recent questions regarding the Food and Drug Administration’s (FDA) oversight of drugs. Yesterday, David J. Graham, associate director of the Office of Drug Safety, told a Senate Committee that FDA's role in reviewing and approving new drugs sometimes conflicts with its duty to address safety issues. Earlier in the week, FDA was asked to account for a serious lack of oversight during preparation of the nation’s flu vaccine supply. DeLauro’s subcommittee has jurisdiction over the FDA.

“I have watched with great concern as FDA's oversight of both its drug and food responsibilities diminished even as the challenges increased. Increasing data shows that FDA did not aggressively pursue the evidence of serious side effects caused by the popular drug Vioxx, and that the agency knew in advance that there would be a shortage of flu vaccines. These actions prove FDA is operating in a very close relationship with the manufacturing companies and appears to be in a regulatory conflict of interest.

“Americans who take medication rely on FDA to protect them. Congress must explore new options to increase FDA oversight by revisiting issues such as its dependence on user fees. The Agriculture Subcommittee should make this a top priority when Congress reconvenes.”