Saturday, March 15, 2008

Tainted Suppliers Still Not Identified by Baxter or FDA

Months after learning of problems with its Heparin Drug, the FDA and Baxter Healthcare continue to look clueless in their response. Consider the latest revelations:

F.D.A. officials said Friday that they had not inspected the Chinese workshops where the raw heparin ingredient originated. The workshops used pig intestines to make raw heparin, a product that eventually ended up at the Chinese plant, Changzhou SPL, which supplied the active ingredient in heparin to Baxter.

Erin Gardiner, a spokeswoman for Baxter, said the drug company had intended “to follow the supply chain as close as we could to the original source — the workshops.” But she added, “We have not been able to do so.”

Ms. Gardiner said Baxter did not have the authority to demand access to the workshops. If such access is granted, she said, Baxter stands “ready to return to China as part of our investigation.”

Quality guru Dr. Deming stressed "knowing your supplier". How can a company making critical life saving drugs not have the ability to assess the quality of its supplier's processes, that includes subcontracted work? Who came up with that purchase contract?

Baxter's supplier, Scientific Protein Labs owns part of the Chinese firm making the ingredient. SPL was purchased by an investment company in August 2006. Does American Capital Strategies not understand quality or is the barrier coming from the Chinese government? The Red Storm's suboptimal management practices, combined with American CEO's contracting obsession, ensure future quality debacles.

We now have at least six stooges trying to re-wallpaper the living room, the FDA, its Chinese counterpart, Baxter, SPL, the ingredient bundlers, the untouchable workshops, and American Capital Strategies. It's been since late last year that Baxter learned of adverse drug reactions to its heparin drug. And no one has been able to assess the source of ingredients. Amazing, and sadly so...