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US Congress Rebukes US Agency Over Inspections of Food and Drug Imports


Members of Congress have sharply criticized the U.S. Food and Drug Administration, saying underfunding and a failure to act aggressively to increase foreign inspections is putting Americans at risk from dangerous drug and food imports. VOA's Dan Robinson reports from Capitol Hill.

For the fiscal year beginning in October, the Food and Drug Administration requested a $130 million budget increase, with the intention of improving its capabilities to inspect foreign companies manufacturing drugs for the U.S. market.

Democrats and Republicans on Capitol Hill question why more has not been done already to correct management, staffing and technological obstacles hampering more effective oversight of drug and food imports.

Among the most controversial problems are inspections in China, where U.S. and European test results identified contamination in ingredients used to manufacture the blood thinning medicine heparin.

According to the U.S. Government Accountability Office, which is the investigative arm of Congress, the FDA has made some progress in increasing inspections, but only 10 to 20 of more than 700 Chinese companies shipping drug products to the U.S. are inspected each year. Lawmakers note that U.S. law contains a requirement for inspections of domestic companies, while there is no law requiring the same for foreign ones.

FDA commissioner Andrew von Eschenbach says steps are under way to establish offices in China and elsewhere to prevent dangerous products from entering the U.S. "The increasing global nature of product development and production requires our continuous and intensive interaction beyond our border. This plan includes the establishment of FDA offices in China, India, Latin America Europe and the Middle East," he said.

While agreeing that the low inspection rate is unacceptable, he asserts that merely increasing the number of inspections would be insufficient.

He was confronted by an angry Democratic Congressman John Dingell, who noted that the FDA budget for all inspections totaled just $11 million, and questioned the Bush administration's commitment to correcting the problem.

"You are not soliciting the resources that you need to do your job to protect the American people the way the law says you should, and that you are tolerating an administration which is allowing this kind of situation to obtain because they are too damn tight to see to it that the American people have the funds that are necessary to protect them against wrongdoing in foreign countries."

Eschenbach addressed differences with China over a U.S. finding that problems with the drug heparin were caused by what the FDA calls significant deviations from good manufacturing processes by a Chinese company, saying U.S. analysis methods are more accurate.

Where heparin is concerned, he says the FDA has ensured the safety of future supplies, and he had this response to a question from Louisiana Congressman Charles Melancon.

MELANCON: "Given China's fundamental difference in understanding the science used to assess what is causing the tainted heparin problem, can we trust the Chinese to adequately regulate our drug supply, since it appears that the FDA isn't prepared to do it?

ESCHENBACH: Well, the FDA is working very directly with our counterparts in China. They are engaged I think in a very conscientious effort to improve their entire system within the country. I have met with their minister of health who believes this is as important to the health and welfare of Chinese people as it is to the rest of the world."

According to U.S. figures, 62 people died from allergic reactions associated with batches of heparin that were recalled.

Eschenbach declined during testimony to make a specific request for funds required to increase foreign inspections, although he agreed with lawmaker's rough estimates of 60 to 70 million dollars.

Chinese government officials this week requested additional samples of heparin from the U.S. for further testing, and asserted that besides the United States and Germany, heparin doses used in 10 other countries had caused no side effects.

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