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FDA takes heat from Congress for heparin scare

Executive Summary

Letters criticizing FDA following a heparin safety scare to FDA Commissioner Andrew von Eschenbach and HHS Secretary Michael Leavitt claim the agency has "deliberately failed to apply" its pre-approval "inspection policy to drug manufacturers in China." The Feb. 21 letters, from House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Subcommittee on Oversight and Investigations Chairman Bart Stupak, D-Mich., follow a Feb. 19 announcement from an FDA compliance official that the agency inspected the wrong heparin active pharmaceutical ingredient manufacturer, a fumble that may be related to a recent safety scare including four deaths associated with Baxter heparin products. The congressmen are considering legislation requiring FDA to inspect a firm before it ships product to the U.S...

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