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Prescription for trouble

Just two years ago, the U.S. government was confiscating Canadian pharmaceuticals that had been ordered by mail and online by American patients looking to save money. The stated rationale was that consumers had to be protected from drugs that might fail to meet this country’s manufacturing standards.

But the latest pharmaceutical threat to American health hasn’t come from Canada. It has come from Illinois, from heparin, a blood thinner manufactured by Baxter Healthcare Corp. It wasn’t obtained via mail order or the Internet, but administered in this country’s hospitals. So far, at least 19 people have died and hundreds have been sickened by the drug, which was largely produced in China to save money, but with so little oversight that the U.S. Food and Drug Administration cannot figure out where in the supply chain a contaminant, a cheap mimic of the active ingredient, was introduced.

After various scandals involving Chinese products -- pet food, toys, seafood -- many Americans already avoid products labeled “Made in China.” But hospital patients have no way of knowing where a widely used pharmaceutical was manufactured or where its ingredients came from. They don’t put such information on IV bags, as though stroke victims are in a position to check anyway.

It took a long line of regulatory failures and legal loopholes for a contaminated drug to reach U.S. hospitals. Last year, the FDA weakened its policies for inspecting pharmaceutical plants, so the drug had never been checked before entering this country. Plants in this country are subject to unannounced inspections, but China eschews them. Chinese inspections are lax, and inspections by the understaffed FDA are far too infrequent.

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Legislation in the House Energy and Commerce Committee would help, though it would not solve all the shortcomings. HR 3610 would require more FDA inspection of overseas plants, paying for increased staff through fees on the manufacturer. It also would require pharmaceutical labels to show where the drugs were made.

But the United States also must not bow to China’s reluctance on unannounced inspections. It’s a strange commentary on governmental priorities when U.S. consumers aren’t allowed to save money on foreign drugs but pharmaceutical giants are. If China wants to sell sensitive products to this country, it should have to learn the old maxim “The customer is always right.” Lately, the saying that comes to mind more often is “Let the buyer beware.”


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