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FDA Way Behind in Inspections of Overseas Manufacturers

Jan 29, 2008 | Parker Waichman LLP The Food & Drug Administration (FDA) has not been able to keep up with its inspections of overseas plants that produce foods, drugs and medical devices sold in the US, and is now so understaffed that it will take decades – and in some cases centuries – to clear the backlog.  That startling information comes from a series of reports on the FDA’s performance authored by the Government Accountability Office (GAO) recently obtained by The New York Times.   The GAO’s investigation is just the latest probe of the FDA to find that the agency is in serious trouble.

According to the GOA report, the FDA would need at least 27 years to inspect every foreign medical device plant that exports to the US, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.   Of course, that’s only if FDA inspectors could actually  find these overseas manufacturing facilities.  The GAO says that FDA computer systems are so awful that the agency doesn’t even know how many overseas plants it should be inspecting, and it cannot produce a list of those that have not been inspected.  

According to The New York Times, the situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where FDA. inspections are few. That’s particularly disturbing, considering China’s poor reputation for manufacturing quality.  This year, tainted dog food, seafood and toothpaste where just a few Chinese imports involved in safety scandals.  Given the FDA’s inadequate performance, it’s no wonder that so many faulty imported products made it past inspectors.

The main reason for the FDA’s poor performance is, as has been cited by numerous other investigations, its budget.  According to The New York Times, in the last 14 years, the FDA has lost 1,311 employees and nearly $300 million in appropriations to inflation while Congress has passed more than 100 laws defining or expanding its regulatory responsibilities. The agency now regulates about $1 trillion worth of goods, or 25 cents of every dollar spent by consumers.

According to the Times, FDA field inspections have fallen off dramatically, particularly in the area of food. In 1973, the FDA undertook 34,919 food inspections; in 2006, that number had dropped to 7,783.  As the share of imported food, drugs and devices has soared, the number of agency import inspectors has plunged, to 380 in 2006 from 531 in 2003. Although 80 percent of the nation’s drug supply is now imported,  the FDA. last year inspected only 30 of more than 3,000 foreign drug plants. It inspected 100 of 190,000 foreign food plants. The backlog of inspections is even worse among foreign medical device plants. Over a six-year period, the agency inspected only 64 of the nearly 700 medical device plants registered in China

Clearly, the FDA’s budget and staff needs to be bolstered, and many in Congress have advocated for more funding for the agency.  But the Bush Administration apparently doesn’t see the situation as being dire.  According to the New York Times, the administration feels the FDA can reform the system “within available resources.”  But with the FDA’s “available resources” being so slim, it’s difficult to see how the agency will do that.

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