Biotech Values

[oldberkeley]

Government investigation
Reports: FDA spread far too thin
Thousands of drug, food plants going without inspections
Tuesday, January 29, 2008 3:14 AM
By Gardiner Harris

http://www.dispatch.com/live/content/national_world/stories/2008/01/29/nyt_fda_inspect_0129.ART_ART_01-29-08_A3_4S96MH2.html?sid=101

THE NEW YORK TIMES
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 FDA inspections are few.

These findings come from a series of reports by the Government Accountability Office, obtained by The New York Times, that are scheduled to be released today 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 FDA is so overwhelmed by a flood of imports that it is incapable of protecting the public.

"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 before the committee.

Warnings about some of these problems have been sounded for years. And there have been fitful efforts at reforms. Last year, Congress passed and President Bush signed a law that changed the way the FDA regulates the drug industry.

But recent disasters involving several of the agency's responsibilities -- a withdrawn painkiller, an unsafe implantable heart defibrillator, deadly pet food and contaminated spinach -- led to multiple congressional investigations that came up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: The agency is near the breaking point.

"Our investigation has found ample evidence that FDA inspections across the board are sorely lacking," said Rep. John D. Dingell, D-Mich., who is 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 funding. Bush recently established an import-safety working group to reform the system "within available resources."

In the past 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's field-inspection force has suffered, 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.