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Globe editorial

Condition critical at the FDA

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February 3, 2008

THE US Food and Drug Administration is supposed to guarantee the safety of one-fourth of all the goods American consumers buy with 1,311 fewer workers than it had 14 years ago. As a result, FDA staff now inspect US companies that make medical devices, such as heart pacemakers, just once every three years instead of two years, as required by its own rules. The situation is far worse when it comes to inspection of foreign makers of medical devices, prescription drugs, and food. Last week a House subcommittee learned from two reports on how incapable the agency is of fulfilling its responsibilities.

Congress itself must shoulder much of the blame. In the past 14 years, its spending on the FDA, now at $2 billion, has declined by $400 million in inflation-adjusted dollars. The one function of the agency for which Congress has ensured adequate funding is the approval of new drugs, and lawmakers did that by requiring the drug companies themselves to carry much of the cost. The safety of drugs already on the market gets few resources, however - a factor in the failure to quickly detect the heart problems that the painkiller Vioxx was causing. The message from both a Government Accountability Office investigation and one by the agency's own advisory Science Board is clear: The country cannot risk the continued short-changing of this critical agency.

The attrition in personnel has been especially acute among inspectors of the exploding market in imported goods. While 80 percent of all drugs sold in the United States are made overseas, the number of import inspectors has plummeted, from 531 in 2003 to 380 in 2006. In 2007, the FDA inspected just 30 of several thousand foreign drug-making plants. It inspected just 100 of 190,000 foreign food plants.

The GAO report provided a telling example of what ails the FDA. It found that one agency computer program came up with a 3,000 count for foreign drug plants that supply the United States. Another agency computer program, which is not compatible with the first, put the total at 6,800.

The Bush administration has shown little appetite for the major increase in funding the FDA needs. Recently, it established a working group on the safety of imports but it stipulated that any reform proposals should be "within available resources."

Those resources are so insufficient that a former associate commissioner of the FDA, William Hubbard, told the Globe last year that the FDA checked just 2 percent of all food imports from China, a country with a record of shipping food contaminated by carcinogens, filth, and pesticides. Congress should boost FDA spending to whatever level it takes to restore public trust in the agency. Right now, it is failing in its mission to protect buyers of food and medicines.

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