FDA Chief Faces Wrath of Congress

"FDA's plans represent a step forward in filling the large gaps in FDA's foreign drug inspection program, but do little to accomplish short-term change," Crosse said.

The GAO said, as early as 1998, that the FDA needed to improve its foreign drug inspection program. Last November, the GAO released a report revealing that the FDA was unaware how many foreign drug makers were sending their drugs to the U.S.

The GAO noted one database showed 3,000 registered makers and another revealed that 6,800 makers actually shipped their drugs into the country last year. The report placed blame on a serious lack of human and economic resources, flaws in FDA databases and IT systems, and inadequate permanent operational support in foreign countries.

"How can there be any confidence that the FDA is adequately regulating foreign drug firms when the FDA has no idea who's making what, where they are physically located, and when they were last inspected?" asked Stupak.

"Last year, this nation's regulatory failures resulted in dead dogs and cats; this year, it has tragically led to the deaths of people," Stupak said. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next 'melamine' or 'heparin' tragedy will soon be upon us."

"The FDA can be re-built but it will be expensive," said Carl Nielsen, retired director of the FDA's office of regulatory affairs. "The public health cost is higher, though, if no significant investment is made, as demonstrated by the heparin incident."

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