The New York Times
Tuesday 29 January 2008
Washington - The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.
Computer systems at the drug agency are so inadequate that it can only guess the number of the plants, and it cannot produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where F.D.A. inspections are few.
These findings come from a series of reports by the Government Accountability Office - obtained by The New York Times - scheduled to be released Tuesday at a hearing of the House Energy and Commerce Committee.
The reports and a recent assessment by the agency's Science Board conclude that the F.D.A. is so overwhelmed by a flood of imports that it is incapable of protecting the public from unsafe drugs, medical devices and food.
"This is a fundamentally broken agency, and it needs to be repaired," said Peter Barton Hutt, a former top lawyer with the agency who will testify Tuesday before the committee.
Warnings about some of these problems have been sounded for years. And there have been fitful efforts at an overhaul. Last year, Congress passed and President Bush signed a law that changed the way the F.D.A. regulated the drug industry.
But recent disasters involving several of the agency's crucial responsibilities - a withdrawn painkiller, an unsafe implantable heart defibrillator, deadly pet food and contaminated spinach - led to multiple Congressional investigations that came up with the same finding: After decades of political neglect, the agency is near the breaking point. As a result, there are growing calls on Capitol Hill to provide the agency with substantially more money.
"Our investigation has found ample evidence that F.D.A. inspections across the board are sorely lacking," said Representative John D. Dingell, Democrat of Michigan, the chairman of the House committee. "How many more examples are needed to demonstrate that this agency is struggling and the public health is at risk?"
The Bush administration has reacted coolly to calls for more financing. Mr. Bush recently established an import safety working group to reform the system "within available resources."
An illustration of the agency's situation comes from a comparison of the allocated budgets of it and the Centers for Disease Control and Prevention. In 1987, the two had nearly identical budgets. Last year, the C.D.C. received nearly four times the amount given to the F.D.A.
In the last 14 years, the drug agency 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.
The agency's field inspection force has suffered, particularly in the area of food. In 1973, the F.D.A. 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 F.D.A. last year inspected only 30 of more than 3,000 foreign drug plants. It inspected 100 of 190,000 foreign food plants.
"I think we've had a cascade of serious warning signs that the levies are leaking," said Dr. Garret A. FitzGerald of the University of Pennsylvania, a member of the agency's Science Board. "We need to respond to these warnings before the hurricane hits."
Investigators for the Government Accountability Office found that, in many of its functions, the F.D.A. was unable to provide even basic information about its inspection responsibilities. For instance, one of the agency's computer programs estimates that 3,000 plants export drugs to the United States. Another entirely incompatible program pegs the number at 6,800.
The backlog of inspections is even more profound among foreign medical device and food plants. Over a six-year period, the agency inspected 64 of the nearly 700 medical device plants registered in China. Medical devices can include items like stents and spinal screws.
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