January 22, 2009

I've been predicting major food poisoning for the past eight years, and how ironic is it that the most prominent example happens only after Bush is on the way out the door?

I used to work for an FDA-compliance consulting firm, and shortly after Bush took over, the FDA called all its agents back from the field "to rewrite the field manual" (even though it was updated on a regular basis) and announced they would no longer do random inspections of facilities. In fact, the only manufacturing facilities they would inspect were the ones that were already operating under a consent order!

There was even an FDA FAQ directed at employees: Q. "Isn't this defacto deregulation?" A.: "Of course not! We are simply trying to make the agency more efficient." (Hint: Whenever they spell out an objection in order to deny it, it's usually a dead giveaway.)

I was appalled. I gathered up all the supporting documentation and started making phone calls to science and business reporters: The New York Times, the Washington Post, the L.A. Times, the Boston Globe, even the trade industry publications.

No one was interested. Everyone I spoke to said they found it hard to believe that the U.S. government would risk the food and drug supply like that and treated me like a crank.

Not so far-fetched now, huh?

The Food and Drug Administration is not staffed to handle the growing complexity of food inspection, especially now that a significant amount comes from abroad and is never inspected, a leading candidate to head the embattled agency said yesterday.

Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic - and reported to be on President Barack Obama's short list to become FDA chief - said food inspection is swamped by the FDA's other responsibilities: the approval of medications and medical devices.

The result is an overworked and understaffed agency continually hit by sweeping food scares that sicken scores of people and sometimes result in death.

"The truth be told, the FDA is a failed agency ... the main problem is that it is terribly underfunded," Nissen said. "It needs to do more inspections, especially of foods brought in internationally. We are all very vulnerable. This has to be fixed and fixed quickly."

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