The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.
The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.
Joseph Famulare, deputy director for compliance at the FDA’s center for drug evaluation and research, said yesterday in a conference call with reporters that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA thought the application had come from a different company with a similar name that had already been inspected.
“To date this is an isolated situation, but the wrong firm was put into the database,” he said. Famulare declined to name the Chinese company approved by mistake.
Perhaps someone could enlighten me on how Mr. Famulare could know that. It seems to me that the most he could know is that they’re unaware of whether it’s an isolated situation or not.
If it makes you feel any better, the FDA isn’t required to inspect foreign drug manufacturing facilities at all and reportedly only inspects something like 10 or 20 of the 700 or so pharmaceutical manufacturing facilities in China that ship to the U. S. annually.
At this point we know that 350 or so American have been made sick or died as a result of using tainted heparin, that the Chinese facility from which Baxter has been importing its heparin hasn’t been licensed by the Chinese government for pharmaceutical manufacturing, and that the FDA certified this facility by mistake. What could possibly go wrong?
This particular facility has only been manufacturing heparin since 2004. Another example of Bush Administration incompetency or institutional incompetency on the part of the FDA? You be the judge.
Meanwhile, let me make my pitch again for country of origin laws for food and drugs—going down to the ingredient level. Let the market decide.