If Toxic Dog Food Gives You a Headache ....

If toxic dog food from China gives you a headache, you might want to slow down before you swallow those generic aspirin.

It turns out that that increasing amounts of prescription drugs and foods -- including most generic aspirin -- is now imported from overseas. And while Bayer (a German company) might have been a major supplier of aspirin in the past, today your generic drugs are more likely to have been manufactured in China or India.

The problem? The FDA does little or no inspection of manufacturing plants overseas.

A few quotes from today's New York Times piece to brighten your day:

• "European factories close; Chinese ones open. Consumers like their commodities cheap, in the case of aspirin as with everything else. China now produces about two-thirds of all aspirin and is poised to become the world’s sole global supplier in the not-too-distant future. But are the Chinese factories safe? Who knows? The U.S. Food and Drug Administration, the European Medicines Agency and other competent government regulators rarely, if ever, inspect them."



• "Last year, generic drug applications to the F.D.A. listed 1,154 plants providing active pharmaceutical ingredients: 43 percent of them were in China, and another 39 percent were in India. Only 13 percent were in the United States."



• "The F.D.A. regulates more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. The agency is responsible for monitoring a third of all imported goods, from eggplant to eyeliner, microwave ovens to monoclonal antibodies, slaughterhouses to cellphones. But with fewer than 500 import inspectors and computer systems so old that repairmen must be called out of retirement to fix them, the agency is increasingly beset by a sense of futility."



• "Over the past six years, the F.D.A. has managed to inspect annually an average of just 15 of the 714 Chinese drug plants that export to the United States. At its present pace, the F.D.A. would need more than 50 years to visit all of these Chinese plants. By contrast, the F.D.A. inspects domestic drug plants every 2.7 years."



• "During a 2001 trip, for example, two F.D.A. inspectors visited a plant that was exporting acetaminophen to the United States. The plant had never been inspected. 'The F.D.A. inspection team was met at the hotel in Wenzhou by representatives from Wenzhou No. 3 Pharmaceutical Factory and . . . transported by public ferry and then company vehicle to the manufacturing facility on Dong Tou Island off the coast of Wenzhou,' their report states. 'There is no street address or plot number, and the address of the facility is given only by the county and province.'"



• "Compounding the problem is the F.D.A.’s antiquated technology. Its computer systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other 6,800. Which number is right? Nobody really knows."



• "This year, 18.2 million shipments of food, devices, cosmetics and drugs are expected to enter more than 300 U.S. ports; the F.D.A. had 454 investigators in 2007 — one and a half per port — to scrutinize them."



• "If not for the low prices from Chinese and Indian producers, millions of people around the world would likely go untreated. And in the United States, buying generic drugs produced abroad is one way to tamp down the exploding health care costs confronting companies and individuals. But there is a hazard: without proper regulation, some of those drugs could be either ineffective or dangerous."
  

The miracle, of course, is that the poisoning of scores of thousands of children (or a mushroom cloud over Washington, D.C.) has not yet occurred.

So what has been keeping us "safe" so far?

Mostly luck and random post-production inspection by importers and distributors worried about their own self-interest.

"Companies that import Chinese pharmaceutical ingredients, including aspirin, are required to test the supplies before using them, and some send private inspectors to China to ensure that suppliers use adequate controls. No pharmaceutical maker wants its name to become synonymous with disaster, and the vast majority of drugs that are consumed in the United States are safe."

In fact, this is the only real protection we will ever have, even if factories overseas are inspected as often as they are in the U.S.

The reason: a single bad production run of food, medicine (or even auto brake pads) can kill thousands. Even under the best of circumstances U.S. manufacturers are only inspected once every two years, which is really next to no inspection at all.

This is not to say that we cannot do a LOT better than we are doing now.

Nor would doing a lot better cost taxpayers a lot of money. As The New York Times notes,

"Unlike reforming Social Security or health insurance generally, fixing the F.D.A. won’t mean allocating enormous sums or necessitate reconceiving the system. It just requires some money and will. There are already legislative changes in the works. Bills now circulating on Capitol Hill would require food, medical- device and drug makers to pay annual registration fees to the F.D.A. Those fees would be used to allow as many inspections of foreign firms as domestic ones."

But, of course, if you want an improved FDA, you cannot continue to salute the notion that businesses are "over-regulated" and that health and safety inspections are "mere bureaucracy" to be swept away like dust bunnies.

Which, I suppose, is a last-minute reminder that the polls open bright and early tommorrow morning.

Vote as if your life depended on it.

Because it really might.


FDA meat inspection, Chicago, 1906
.