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China's drug agency says importing countries must ensure product safety

China's drug agency says importing countries must ensure product safety

China's drug safety agency, commenting on a probe into the recalled drug heparin, said Wednesday it enforces strict controls on chemicals used in pharmaceuticals, but that importing countries are ultimately responsible for ensuring product safety.
The State Food and Drug Administration, in a statement on its Web site, said it was cooperating with a U.S. probe into a factory that makes heparin, a blood-thinning drug that Baxter International has recalled due to adverse patient reactions.
"We attach high importance to this," the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.
But the SFDA said that based on international practice, "safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country."
Deerfield, Illinois-based Baxter recalled thousands of vials of the blood thinner and halted production earlier this month after it was linked to four deaths and hundreds of allergic reactions.
So far, the cause of the adverse reactions remains unclear.
The U.S. Food and Drug Administration is conducting inspections at a Baxter facility in New Jersey, at company supplier Scientific Protein Laboratories of Wisconsin and at Changzhou SPL, a factory in the eastern Chinese city of Changzhou that is 55 percent owned by Scientific Protein Laboratories.
So far, the FDA has not released any findings from that investigation.
China's SFDA said it also was investigating the factory, but gave no details.
It did say that Changzhou SPL's heparin was not registered with the SFDA and cautioned that foreign companies should only import products certified by the SFDA for export as pharmaceutical materials.
China has dozens of heparin manufacuturers. Some are classified as pharmaceutical companies and subject to SFDA inspections. Others are not.
The Chinese food and drug agency apparently did not inspect the factory because it was registered as a chemicals manufacturer, not a pharmaceuticals company.
The heparin scare is the first big issue to arise since Washington and Beijing signed an agreement in December that was meant to improve coordination on food and drug safety following a spate of scandals over tainted or substandard products.
FDA officials say cooperation has improved.
But the heparin case highlights the difficulties both sides face in improving oversight given paltry levels of staffing and funding on both sides. The FDA acknowledged that Changzhou SPL was never inspected by the FDA, contrary to its own regulations, due to what it says was a mix-up with names.
The FDA has defended its track record on inspections.
"Not inspecting the Changzhou facility was a one-time oversight," Riley said.
Heparin, used to prevent blood clotting, is generally made from pig intestines. In China and other developing countries, tracing the source of animals used to make the chemical can be difficult.
The FDA told doctors to stop using Baxter's heparin, citing 350 reports so far this year of side effects, including dizziness, fainting and a racing heartbeat. In 2007, the agency received 100 reports of problems with the drug.
Excess capacity in the Chinese pharmaceuticals industry and lax regulation of chemicals used in drugs means that exports are surging at a time when the U.S. side may not be prepared to step up inspections.
China exported US$13.6 billion worth of chemicals used in pharmaceuticals last year, up 27 percent from the year before, according to statistics compiled by the industry group the China Chamber of Commerce for Import and Export of Medicines and Health Products.
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On the Net:
http://www.fda.gov/
http://www.baxter.com