Tainted Chinese imports spur calls to protect consumer

Toxic blood thinner may have killed as many as 81 people, US says.

Susan Walsh
Grilling: FDA Commissioner Andrew von Eschenbach testified at a congressional hearing on the contaminated pharmaceutical drug heparin Tuesday.

Lead in toys. Melamine in pet food. Toxic chemicals in toothpaste. And now, tainted pharmaceuticals.

The unfolding scandal of contaminated blood thinner from China is the latest in a string of revelations about dangerous imports from a country that has risen to become manufacturer to the world.

US lawmakers now are pushing for more protection for American consumers, as hearings in Congress this week have made clear. Even the head of the Food and Drug Administration (FDA) says he needs more money – and a new approach – to try and ensure that products entering the country are safe.

Other countries may well follow suit. In a world of increasingly globalized commerce, the next frontier may not be more or cheaper goods, but higher quality trade, says Moisés Naím, editor in chief of Foreign Policy magazine.

"What is now happening [with contaminated products] is going to create a big surge in consumer protection demands and expectations," says Mr. Naím, author of "Illicit," a book that details some of the problems of globalization.

According to the FDA, as many as 81 Americans may have died after taking heparin, a blood thinning agent, tainted in China via the addition of a poisonous chemical. US recalls of Chinese heparin ingredients began in February.

Chinese officials don't agree that the deaths were caused by contamination that may have occurred in their country. They say that the problem could stem from manufacturing of the finished drug at a plant in New Jersey.

At a House hearing Tuesday, lawmakers chastised the FDA for not increasing its focus on foreign drug makers after the heparin crisis and other contamination scares.

The FDA inspects domestic drug plants every 2.7 years, on average, they noted. But at the rate they are moving, it would take 13 years to check every foreign drug plant and 1,900 years to check every foreign food plant that ships products to the US.

"It's clear the FDA needs some new thinking on how to deal with the 21st century," said Rep. Joe Barton (R) of Texas.

FDA commissioner Andrew von Eschenbach under questioning admitted that his agency needs more resources. The FDA would have to more than double its current $10 million budget for foreign inspections if it was to check every Chinese drug firm at the same rate it inspects US firms.

But Dr. von Eschenbach added that he believes current inspections would not have caught the contaminated heparin because the toxic chemical it contained closely mimics genuine ingredients.

What's needed, he said, is a five-year improvement plan that adds new information systems and tests, and includes the opening of three planned FDA offices in China. "The solution needs to be much more comprehensive than just simply inspecting a facility," said the FDA chief.

A Senate hearing Thursday is set to address the same issues. The Senate has already passed a measure giving the FDA a 20 percent increase in funds, though it's unlikely the White House will give final approval to such a jump in appropriations.

If the Chinese government inspection process was similar to that in the US, there would not be as much of a problem in regards to worry about tainted products entering America, says Joel Trachtman, a professor of international law at the Fletcher School at Tufts University in Medford, Mass. But it isn't. And right now "they don't coordinate very well," he says.

The main question for the US is not how to punish the Chinese, but how to assist them moving forward, he says. Chinese citizens do not want to suffer from tainted products anymore than citizens of other countries in the world. Nor does Beijing want to see exports wither due to foreign concerns. "China needs to understand its broader long-term commercial interests here," says Mr. Trachtman.

Right now, the FDA plans to open its Chinese offices in Beijing, Shanghai, and Guangzhou. They will employ 13 people – eight from the US, and five locals.

China has yet to agree to final implementation of this plan. But under the terms of the World Trade Organization – which both the US and China belong to – the US has every right to carry out intrusive inspections in China if there is a scientific basis for them, says Gary Hufbauer, a trade and regulation expert at the Peterson Institute for International Economics. "This has been quite damaging to China, but I think the authorities there realize this," says Mr. Hufbauer.

Overall, the demands of policing the vast quantity of products that flow across the world's borders are so large that they will require a global solution, Naím says.

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