Editorial: Chinese chemicals unchecked

Sunday, Nov. 4, 2007 | 1:45 a.m.

A congressional investigation has revealed that the Food and Drug Administration doesn't have the resources to adequately inspect chemicals that are manufactured in such nations as China and are used as ingredients in American medicines.

The House Energy and Commerce Committee, which conducted a hearing on the issue Thursday, assigned a team of investigators to accompany FDA officials as they inspected chemical plants in China and India, where the numbers of companies making pharmaceutical ingredients have increased significantly.

In China alone the FDA keeps track of 700 companies that manufacture chemicals that are used in U.S. pharmaceuticals, but the FDA has only enough resources to perform 20 inspections there a year, the congressional investigators reported.

And there probably are significantly more Chinese plants that provide drug ingredients without the FDA's knowledge. An in-depth story by The New York Times last week reported that China has about 80,000 chemical companies that export drug ingredients to pharmaceutical makers in at least 150 countries, including the United States. Chemicals from these companies often go through complicated chains of distributors.

What's more, Chinese drug regulators don't inspect these companies or certify their chemicals because the chemicals, on their own, aren't active drug ingredients. Therefore, they are not subject to any inspection in China, the Times reports.

As a result, adulterated or phony ingredients - and in some cases even poisons - have ended up in medicines sold in some countries. At least 138 Panamanians died or were sickened last year after a Chinese company sold a poisonous chemical to a company that put it in cold medicine.

It is beyond reason to think that the inspection of 20 plants a year in China is enough to protect American consumers when more than 700 companies there are making drug products for the United States.

This industry is unregulated by Chinese officials, and it certainly lacks adequate oversight by the United States.

Although it might be impractical - impossible, even - to immediately halt the import of all drug-making chemicals from China, it is reasonable to expect the FDA to inspect these foreign manufacturers annually and allow imports only from those companies that we trust.