By Francine Knowles

Sen. Dick Durbin signaled Sunday that more inspections of imported drugs and other products from China are needed in the wake of news that a tainted imported medicine, heparin, caused deaths and allergic reactions.

While the U.S. Food and Drug Administration is in the midst of investigating the matter, Durbin said the action is "entirely inadequate and indicates not nearly enough is being done to inspect these imports."
He has called on the agency to detail how it monitors drug and drug ingredient imports from China and how it plans to prevent future problems.

Speaking to reporters outside Federal Plaza, he cited other recent problem imports from China in the last year, including tainted pet food, toothpaste and toys.

13 of 500 checked

"In each and every instance, we found that the lack of surveillance in China, the lack of adequate inspection, resulted in dangerous products being sold in America, often with disastrous consequences," he said.

"The latest episode may be the worst. To think that we are importing drugs, pharmaceuticals, from China without adequate inspection is entirely unacceptable."

The New York Times reported Sunday that more than 500 plants in China export drug ingredients to the United States, but the agency inspected only 13 of them last year.

Heparin, a blood thinner used in surgery and dialysis, is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China.
Contaminated heparin, marketed by Deerfield-based Baxter International Inc. and produced in China, has been linked with 19 deaths and hundreds of allergic reactions.

The FDA said earlier this month that Baxter's heparin was contaminated with a less-expensive ingredient derived from animal cartilage. The contaminant isn't approved for use in medicine. Regulators are investigating whether the substance was intentionally or accidentally added to raw heparin from China.

Seeks inspection data

Following reports of adverse reactions, Baxter in February recalled all heparin vial products.

Durbin has asked the FDA for data on the number of inspections of foreign drug and drug ingredient producers' plants conducted in each of the last five years -- and on the countries in which they've taken place. He also wants information on how the agency determines which overseas facilities to inspect, the funding and personnel dedicated to inspecting overseas plants, and safeguards U.S drug makers are required to take to ensure ingredients from overseas suppliers are safe and effective.