U.S. Health and Human Services secretary Mike Leavitt told the Associated Press on May 12 in Shanghai that heparin manufactured in China is now safe because of tighter testing and controls, but warned that all U.S. imports would face closer scrutiny in the future.
He said all exporters of food, drugs and other products must prepare to meet more stringent guidelines of quality and safety, following a raft of product safety problems stemming from lax standards among overseas producers, especially in China.
"We believe the system that we have for ensuring safety is a good one but completely inadequate for the future," Leavitt said. "What you'll see from the United States is a substantial change in our strategy," he added, noting Washington's plans to station USFDA inspectors in China and other countries.
Leavitt said he was optimistic that American and Chinese officials could soon resolve a dispute over the FDA's investigation into the cause of deaths and reactions linked to heparin. Leavitt was due to meet later with China's minister of health to discuss various issues.
China's SFDA has complained that Baxter was not cooperative its own inquiry into the problem by refusing to provide details on victims and specifics about production. The Chinese agency contends that it is too early to conclude that a contaminant found in raw heparin exported to the United States caused the adverse reactions.
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