Feb 17 2008
heparin update
An update on this breaking story from the New York Times. Earlier, I pinned the blame on both the U.S. FDA and Baxter because neither did quality control on the Changzhou plant. Well, it seems like there is a third party that can take some of the blame as well: China’s Drug Agency. Here is an excerpt:
A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.
Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.
Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.
The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license.
Of course, I have not yet blamed the Chinese factory. Yes, they were not licensed to produce these products, so they share some of it. But really, Baxter should’ve been doing more due diligence, not to mention both countries’ drug regulatory bodies. (whether or not it did a “reasonable” amount of due diligence is not my problem because human lives are at stake–you could always do more) It’s scary how much can slip under the radar. But as the Times mentions, we still don’t know if it was the Chinese manufacturer:
The heparin plant in China has not been accused of providing a harmful product. The American majority owner of that plant, Scientific Protein Laboratories, also owns a plant in Wisconsin that produces the active ingredient in heparin for Baxter.
So here the most astounding fact: the U.S. FDA proceeds so slowly that it would take 35-70 years to do an inspection of all approved drug plants in China, not to mention the fly-by-night types. This is downright scary:
Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.
So who’s to blame? I think the U.S. FDA should bear much of the brunt on this. They can do better. And then Baxter for failure to quality control their products. If the Chinese factory is properly linked to the deaths, then it definitely has the lion’s share of it. But until then, let this be another warning to all who would import Chinese products: Caveat emptor.
You are speaking completely out of your hat and it is unfair, maybe even libelous. What do you really know about this case? Did it ever even occur to you that the plant in China is not required to be licensed to sell pharmaceuticals because it was not selling pharmaceuticals? It was selling an ingredient. Before last week, did you even think the FDA inspected all ingredient plants around the world? Of course not. You say Baxter should have done better due diligence, but do you have any idea what due diligence it did? There is also no evidence yet that the plant in China is the source of the problem. You are a lawyer, so act like one.
Yes, I am speaking out of hat. This is not entirely a law blog. I talk about law, but who wants to talk only about law? That’s quite boring. And second, who says I can only opine about law? Do I need to be an “expert” in any field to opine? No. Perhaps in a court of law my testimony would be struck, but I don’t believe there is a need to be an expert about everything I post. (Nor am I lawyer for Baxter or the FDA.)
But to say a company should have been doing more due diligence, I don’t believe that is libelous. I believe that is true. There is always something more a company could have done because hindsight is 20-20. But my point is that every company should ramp up its due diligence in light of a lot news stories. (like today, the whole standards for toys being ramped up)
A bit unfair? Perhaps since we don’t know all of the facts and many of them are still developing. That’s given by the nature of the story. But I think you misread my article b/c I lay quite a bit of blame on the FDA. A lot actually. Second, this isn’t Baxter’s first problem in the last couple years as I recall. Third, I never blamed the China plant. I said IF it was the China plant. But my last 2 posts, I have never laid the blame on the China plant without evidence. I am not joining the China-phobia of many–that is not the point of this blog.