Heparin probe reveals global drug market perils

Importers beware
When FDA experts belatedly inspected Changzhou SPL last month, they found scratched tanks with “unidentified material” sticking to their insides. Records were missing for some of its sources of raw heparin, and testing was incomplete.

“We are a company with high standards. We have nothing more to say to you!” shouted a manager at Changzhou SPL who answered the phone but refused to give his name.

“We have never had chondroitin sulfate on our production list. Just see the official announcements,” he said before slamming the phone down.

A Scientific Protein Laboratories statement emphasized that FDA findings suggest the chondroitin sulfate was in the affected heparin before it reached Changzhou SPL.

“The observations made by the FDA during its inspection do not indicate any fundamental or underlying problems with the Changzhou SPL facility,” the statement said, quoting industry consultant Robert Rhoades speaking on SPL’s behalf.

Importers beware is the principle governing all international trade in drugs and pharmaceutical chemicals, said Shen, of Pharma China.

“For exports, (China) doesn’t regulate anything at all. There is no export licensing system in place,” he said, noting that such chemicals are generally unregulated. “The U.S. FDA doesn’t regulate those exports from the U.S. either.”

FDA officials say a U.S.-China agreement on improving cooperation in drug safety, signed in December, has helped the heparin investigation, though heparin was not on the original list of drugs covered by the pact.

Even with inspections, heparin is tricky, said Liu Jian, an expert on the chemical at the University of North Carolina.

“In producing heparin, it’s very important to control the quality of the raw heparin,” Liu said. “Once you have a contaminant that you didn’t get rid of in the early stages, its very hard to tell what you have there.”

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