Tough luck to unwary buyers, Chinese regulators say. The country's drug safety agency said today that it strictly controls chemicals for use in pharmaceuticals but it's not ultimately responsible for product safety. Importing countries are. In other words, buyer beware. In fact, a State Food and Drug Administration spokeswoman said foreign buyers should check with the agency to make sure their suppliers are certified to make pharma ingredients.
In the same statement, the watchdogs said they're cooperating with a U.S. investigation into a factory that makes raw heparin for a Baxter International supplier. The drugmaker stopped producing its multiuse heparin vials after four deaths and hundreds of adverse reactions in patients using the drug. The U.S. FDA is in country now, checking out the supplier's plant; though Baxter found irregularities in samples from that factory, it's still unclear whether problems with the drug originated there.
Meanwhile, another Chinese plant that makes raw heparin took the Los Angeles Times on a tour, showing the reporter inspection records and telling him about the "arduous process" of obtaining FDA approval. The factory operated by Baxter's supplier had never been inspected either by the FDA or by China's SFDA, the former because of a name mix-up and the latter because it was classified as a chemicals maker rather than a drugmaker.
- read the report from the Associated Press
- see the item at Pharmalot
- find this detailed article in the Wall Street Journal
- check out the LA Times piece