THE ENEMY WITHIN
WHY CAN'T THE FDA KEEP OUR DRUG SUPPLY SAFE?
This, of course, has already happened. But until recently, the U.S. government was planning to do almost nothing to keep it from happening again.
The foreign group wasn't al Qaeda planting dirty bombs - it was Chinese vendors of a product made from pig intestines. The motive wasn't hatred of our "freedom," but likely good old-fashioned greed. The effect is the same.
Researchers have determined that a batch of the blood-thinner Heparin was contaminated when the active ingredient of the drug (made from pig intestines) was cut with a cheap filler.
It no doubt occurred in primitive "workshops" in China that supplied a Chinese plant owned by U.S.-based Scientific Protein Laboratories. SPL sold the ingredient to drugmaker Baxter International, which manufactured the final product and sold it to hospitals.
As a result, at least 81 people died and 785 suffered serious allergic reactions, many of them after routine dialysis treatments. Heparin has been used for decades - with proper oversight, these people would still be alive.
Last year it was contaminated toys, pet food and toothpaste from China. The Heparin debacle is yet another example of how our collective safety is threatened by the "E. coli conservatism" that has infected the federal government. Over two decades, a campaign to reduce "big government" has systematically corrupted regulatory agencies. The result: a serious breach of national security.
The Chinese plant was never inspected. Not by the Chinese, because all its product was being exported. And not by the United States. The Food and Drug Administration thought the plant had passed an inspection, but actually had mistaken it for another with a similar name. (With all the Chinese products flooding our markets, you'd think the FDA would have a few Chinese speakers on staff.) Even with the correct name, it's unlikely the plant would have been inspected, since the FDA inspects less than 11 percent of drug-making plants overseas.
Instead of responding to an explosion of drug imports from other countries - 80 percent of the active ingredients of drugs consumed by Americans are imported - the Bush administration has systematically reduced the FDA's budget.
American drug-manufacturing plants are subjected to surprise inspections at least once every two years. Given its current plans, the FDA would get around to each overseas plant once every 13 years. To actually do the job, an FDA official told Congress recently, it would take $225 million. The FDA spends about $10 million on foreign inspections.
As with traditional national security, individual Americans can't protect themselves from the dangers posed by contaminated drugs administered to them in hospitals. This is something the government must do.
It's time for a total overhaul of the FDA. The U.S. House Committee on Energy and Commerce, chaired by Rep. John Dingell, D-Mich., has drafted one that deserves support. We disagree, though, with its plan to pay for part of the overhaul with "user fees" from pharmaceutical companies. Not only might the costs be passed to consumers, but it's not good public policy to have private companies pay the salaries of the people who are supposed to inspect them. Like traditional national security, this is exactly what taxes are supposed to be for.
Many more Americans have been killed by contaminated imported drugs than by terrorists using hair mousse or shampoo to create bombs on-board planes. It's time we defend ourselves against the true clear and present dangers. *

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