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Heparin and The China Connection

Friday, March 14, 2008  |  posted by Hugh Hewitt
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In “Drug Makers Stick By China,” the Boston Globe profiles the growing dependency on American pharmaceuticals on Cina production facilities, as well as the gap between the FDA’s mission and the FDA’s resources in the PRC:

In the United States, drug imports from China have more than quadrupled in the past five years to $401 million in 2007, according to the International Trade Administration, part of the US Department of Commerce. Roughly 3,000 Chinese companies have registered with the FDA to market medical devices in the United States.

Meanwhile, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, predicted there likely will be more injuries from Chinese medical imports because the FDA rarely inspects Chinese plants. More than 700 Chinese drug makers are registered with the FDA, but the cash-strapped agency conducted just 14 inspections in China last fiscal year. And the visits are seldom a surprise, because the Chinese government generally warns companies in advance. Moreover, Chinese regulators do not inspect plants that export all their products to the United States and other countries.

“It’s inevitable that we will keep seeing more problems until this is taken care of,” Wolfe said.

To understand why concerns over pharmaceutical production in China versus elsewhere are going to be more pronounced, read China, Inc. The scale of the PRC’s massive and very rapid industrialization will simply allow for more mistakes as any too rapid expansion of anything allows for more mistakes. The end result is a huge growth in products, but also flawed toys, dog food, and now drugs.

The inevitable lawsuits against Baxter will focus on the China connection, and American Big Pharma has got to realize that if a second drug manufactured in whole or in part in China kills more Americans, the blowback will be enormous.

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