APRIL 01, 2008

The FDA is under increasing pressure from Congress to beef up its foreign inspections program to improve the safety of imported medicines, especially those from China and India—major producers of active pharmaceutical ingredients and finished drug products.

The Department of Health and Human Services recently announced a memorandum of agreement with China to improve the safety of imported food, drugs, and medical devices, but Congress is continuing to press the issue.

"While I am pleased that [FDA] Commissioner [Andrew] von Eschenbach has taken our advice to open FDA offices overseas," said Rep John Dingell (D, MI), chairman of the House Energy and Commerce Committee. "This is just one step in a long road towards improving food and drug safety."

Responding to concerns over the FDA's failure to inspect a Chinese plant manufacturing 1 of the ingredients in the blood thinner heparin which has been tied to hundreds of allergic reactions, Dingell said: "These heparin tragedies are likely the result of FDA abandoning its preapproval inspection requirement, a critical policy that was put in place two decades ago." He and Rep Bart Stupak (D, MI), who chairs the Subcommittee on Oversight and Investigations, are considering emergency legislation that would prohibit the marketing of any drug from a plant that has not been properly inspected.

In March, the FDA received approval from the State Department to establish 8 full-time, permanent FDA positions at US diplomatic posts in China, pending authorization from the Chinese government.


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