FDA's von Eschenbach shares drug safety vision with US Congress

Andrew von Eschenbach, the Commissioner of the US Food and Drug Administration, presented his vision of the future of drug safety regulation to the US Congress. He noted that the agency is "aware of increased attention" in recent years due to "rapid advances in science and technology that have resulted in increasingly-complex medical products."

In his presentation to the US House of Representatives' Subcommittee on Oversight and Investigations, chaired by Bart Stupak (Democrat, Michigan), Dr von Eschenbach discussed the FDA's response to the Institute of Medicine report, published late last year (Marketletter October 2, 2006),which although commissioned by the agency, was mostly reported as critical of it. He told the Subcommittee that the IOM "makes substantive recommendations about additional steps [the] FDA can take to improve our drug safety program," including "strengthening the science that supports our medical product safety system," improving the information flow among key stakeholders and improving operations and management.

The FDA Commissioner noted that the renewal and improvements to the Prescription Drug User Fee Act (Marketletters passim) would ensure financial support for some of these initiatives.