Mar 02 2008
heparin update part 2: chinese fda lays responsibility on importers
The AP recently published this article regarding the Baxter Heparin probes that arose from 4 deaths and 300+ allergic reactions. There is actually no real information about the progress in tracking where the problem might be. However, the article did have an interesting little tidbit in there that I just had to highlight.
Straight from the horse’s mouth:
SHANGHAI, China (AP) — 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 by Baxter International that is subject to a massive recall 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.”
Let’s be honest here. The Chinese FDA (“SFDA”) is not going to take any responsibility for pharmaceuticals causing problems. Of course, I am sure they wouldn’t want to. 4 deaths for Heparin. Many deaths in the Panama glycerine cough syrup. This is a nasty can of worms here for the SFDA. And so the SFDA’s response is that they will pass the buck for pharmaceuticals.
So does this mean that the U.S. FDA or your country’s equivalent will be willing to shoulder the burden for a defective product that is imported into the country? Likely not. It will be on the importers themselves. If this is not a wake-up call for importers (and if you are doing China imports, this means you), then I don’t know what is. You must do your due diligence, QC, and constant follow-up.
Is this trinity of QC, diligence, and follow up going to make your imports fool proof? Probably not. But hopefully it will at least shield you from major civil liability from plaintiff’s lawyers who would love to go after your products.
