Healthy soil and sustainable growing

[Liz <liz@allslash.org>]

Here's the link to the original: 
http://www.nytimes.com/2008/01/29/washington/29fda.html


For FDA, a Major Backlog Overseas
    By Gardiner Harris
    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responsibilities - a withdrawn painkiller, an unsafe implantable 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.