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EDITORIAL: FDA woes imperil consumers
[March 09, 2009]

EDITORIAL: FDA woes imperil consumers


(Chattanooga Times (Free Press, TN) Via Acquire Media NewsEdge) Mar. 7--These days, the federal regulatory agencies that oversee and regulate the nation's financial affairs justifiably are drawing the most criticism for failing to do their jobs, but the Food and Drug Administration isn't far behind. The reason is obvious. Americans increasingly are convinced that the FDA can no longer meet its mandate to protect them from contaminated food, drugs, medical devices and a variety of other products. There is considerable evidence to support that belief.



The current recall of nearly 3,000 peanut products that could be contaminated by salmonella is the latest manifestation of the FDA's woes. Within the past year or so, the FDA also has had to deal with a salmonella outbreak traced to hot peppers, death-dealing syringes manufactured in unsterile conditions, pet food laced with contaminants and a blood thinner imported from China that caused life-threatening allergies. In every instance, the FDA reacted to reports of problems rather than preventing the problems from occurring.

Perhaps it is too much to ask a single agency to oversee the production of so many items in so many places around the globe. It certainly is unfair to require the FDA to do so with the funding it currently receives and at present staffing levels. That's simply not possible.


The peanut product recall is indicative of the problem. Once reports of salmonella in peanut products were brought to the FDA's attention, inspectors quickly traced the outbreak to the Peanut Corp. of America plant in Blakely, Ga. Once there, though, the inspectors were hamstrung by antiquated rules that prevented them from gaining rapid access to internal company reports. Without those reports or other evidence, the agents had no authority to order a recall.

It was only after inspectors resorted to bioterror laws that they obtained incriminating reports. These indicated that the company knew salmonella was present, but that it nevertheless continued to ship products for nine months. No wonder the company was reluctant to provide the information.

Inadequate staffing makes it impossible for the FDA to inspect all the plants under its jurisdiction on a regular basis. Some, indeed, go years without an inspection. Some companies like it that way. Others turn to private inspectors to assure the public that they are being protected from contaminated items. That can be a mixed blessing.

Done properly, the private reports are thorough and reliable. Sometimes, though, it is a flawed system that operates without proper oversight. That obviously was the case with the Peanut Corp. of America.

A private inspector -- paid for by the company in what clearly was a conflict of interest -- visited the plant which processes millions of pounds of peanuts monthly. He had a day to do the job. When he protested that was not adequate, the company said they'd allow more time next year. He conducted his inspection anyway, turning in a report that, according to a copy obtained by The New York Times, said the food safety level at the plant was "superior." In retrospect, the verdict was hardly surprising.

The inspector was unaware that peanuts were susceptible to salmonella. Even if he had known, he was not required to test for it. The result: A salmonella outbreak -- one of the worst in U.S. history -- in which at least 9 people died and more than 22,000 became ill. Consumers deserve better.

If Americans are to be protected from similar events, the Obama administration and Congress should revamp the FDA and provide the tools and manpower for it to do its job. The George W. Bush administration short-shrifted the agency's budget for years, making it difficult to retain or hire trained staff and to purchase equipment and computers vital to large-scale inspections. The result, as Americans have learned to their chagrin, was as predictable as it was dangerous.

The situation is changing. Congress, perhaps energized by rising public discontent spurred by recent recalls, seems willing to funnel more money into the FDA. President Obama indicates that he might be agreeable to systemic changes at the FDA if that creates an agency able to meet its mandate in a prompt, reliable manner. That's a start.

Additional funding and presidential interest are welcome. But if the FDA is to again be a trustworthy first line of defense against tainted products, more money and sustained interest in agency operations will be required.

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Copyright (c) 2009, Chattanooga Times Free Press, Tenn.

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