US HHS response IOM report on FDA

Mike Leavitt, the Secretary of the US Department of Health and Human Services, has offered his own two-part action plan in response to the recent report into the Food and Drug Adminstration's effectiveness by the Institute of Medicine (Marketletter Oct 2).

He recognised that "admittedly there is a tension between balancing the risks and benefits of innovative new treatments for patients in need of hope," adding that there were two steps that "can be taken quickly and that will have a dramatic impact" to further efforts to ensure drug safety.

Mr Leavitt said: "first, I call on the Senate to quickly confirm Dr Andrew von Eschenbach as FDA Commissioner. The FDA needs permanent leadership and Dr von Eschenbach has the energy, the vision and the support to bring to our drug safety review process into the 21st century." Dr von Eschenbach's nomination is currently held up in the US Senate by two dissident members of the Republican majority: Senators Jim DeWint (South Carolina) and David Vitter (Louisiana) over drug-related issues (Marketletter September 25). It is increasingly likely that the issue will be postponed to after the mid-term elections. If no decisive outcome is possible before the end of the year, President George W Bush would be required to re-issue a nomination for FDA Commissioner.