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Policy

FDA Faulted For Lax Oversight OF Foreign Drugs

April 28, 2008 | APPEARED IN VOLUME 86, ISSUE 17

Lawmakers sharply criticized the Bush Administration last week for not doing enough to protect Americans from tainted medicine and food produced overseas. House Energy & Commerce Committee Chairman John D. Dingell (D-Mich.) noted at a hearing that 80% of all active pharmaceutical ingredients are now imported, but FDA has the money and staff to inspect only about 7% of the more than 3,200 plants worldwide that ship drugs to the U.S. "You are carrying water for an Administration that is not giving you the resources you need," Dingell told FDA Commissioner Andrew C. von Eschenbach. The Government Accountability Office estimates that FDA would have to spend up to $71 million a year to inspect all of the foreign drug manufacturers listed with the agency once every two years. FDA has budgeted $11 million for overseas inspections this year. Von Eschenbach said the increased globalization of manufacturing "has placed tremendous strains on our import safety system," and he acknowledged that additional resources are needed. Concerns about FDA's foreign inspection program stem from a series of recent drug and food safety scares, including contaminants in Chinese-made ingredients for the blood thinner heparin (see page 14) and melamine-laced pet food.

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