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Heparin Case: China Says Responsibility For Quality Lies With Importing Nations
By Paul Midler | March 2, 2008
While claiming that it attaches high importance to quality standards, China has claimed it bears no responsibility in assuring quality for pharma products leaving its shores. As many as 400 illnesses and 21 deaths have been linked to tainted heparin produced in China. The FDA went to China only after the news of contamination broke, and the plant was said to be in sorry shape. The FDA has not been inspecting China plants often. Here are some numbers to think about…
“The inspection shortfall is particularly acute in China. The FDA has averaged just 15 inspections in China in each of the last five years. Yet China’s fast-growing industry now numbers 714 plants that ship drug products to the U.S. At that rate, it would take the agency nearly 48 years to inspect each plant just once — and well more than that, if China’s booming 17 percent annual growth rate for drug exports is taken into account.”
It is worrisome that China insists it bears no responsibility. China certainly wishes to assure high quality standards for the products that are produced in its country. It is in its best interest to export only quality goods - regardless of who owns the factory. When China says that it cannot guarantee quality, maybe it means that it is incapable. Question: If China can’t get the job done from home, how successful can we expect the FDA to be in doing the job from afar?
Topics: China |
March 2nd, 2008 at 9:02 am
If every country sends its own inspectors, that’s going to be a lot of traffic in and out of China. Maybe that’s why they built the new airport in Beijing.
March 2nd, 2008 at 4:34 pm
The bottom line is that the Chinese government lacks the ability control it’s vast country…period. The fact that 90% of China’s millionaires are the spawn of Communist Party leaders points a big greasy finger at the real problem. In my opinion the FDA bears the brunt of the responsibility to protect Americans period. No excuses. If they can’t inspect the Chinese drug producing factories effectively then we shouldn’t allow the drugs from the “uninspected factories” into the county. Easy solution.
March 2nd, 2008 at 8:28 pm
Jack - That’s the kind of strong opinion I like. Better than coffee in the morning. Not sure that I agree that the FDA *should* bear the responsibility, but more worried that the FDA cannot handle the burden. And never mind that US taxpayers are picking up the tab.
March 2nd, 2008 at 11:58 pm
No… the responsibility of ensuring quality lies with the people sitting plush office reaping in 2000% mark up in retails. If developing countries have the advance quality assurance know-how, among other things, chances are they don’t have to be taking the salami-sized profit from foreign manufacturers. In the ideal world things would just “work” such that you order something from China and it will arrive 3 month later in perfect shape with no hiccup at all.
Why the hell do you think people in developed countries are allowed to just sit there in office sipping coffee and draw 6 figure salary? Knowledge of course, knowing the “software” side of things and managing the production of the “whole product”. That include ensuring the quality of the product from start to finish and assume all the risks associated with it.
People simply need to do their job and earn their fair share. The responsibility of the quality of the product lies squarely at the foot of those who earns the most money.
March 3rd, 2008 at 8:13 pm
China’s claim is going to increase their market share in the world by at least a 100%. People will be so impressed with them that they would insist to get drugs made in China.
April 13th, 2008 at 8:25 pm
My father on law die 02/21/2008 from dialisy they used Heparin contaminate they fail on coma for 3 weeks ,same day he get in to South Miami Hospital 3 other people get on CCU for same problem Heparin that what Doctor tell me that day.\
Thanks
Arnaiz