Beijing: US Regulatory Failures Responsible for 19 Deaths

You don't have to be a China watcher to know that the safety of Chinese made products has become of increased concern to US consumers over the last year. Indeed, you only need to have tuned into the conservative media for a moment to have known that one of the leading questions during the 2007 holiday season was whether or not it was safe to buy Chinese made toys due to the large number of recalls.

Equally, you don't need to be a China watcher to know that the same kind of questions that are being asked of Chinese made toys are also being asked  Chinese made pharmaceutical.

The later of which is in no small part due to the on going case of Baxter International which is being investigated by the Food and Drug Administration in connection to over a dozen deaths in the US: With Chinese made ingredients being the prime suspect.

However, what you may need to be a China watcher to know is that the primary culprit in this case may not be a Chinese company at all, but rather one based in Wisconsin, and that Baxter's product problems may have a lot more to do with US regulatory failing than sharp practices in China's drugs industry.

Reasoning?

The reasoning behind this, as China watcher have noted, is two fold.

Firstly, while the ingredients that are at the top of the suspects list in the Baxter case were manufactured by a company located in China - namely Changzhou Scientific Protein Laboratories - said company is only partially Chinese. The rest of what it is is American. Changzhou Scientific Protein Laboratories (better known as Changzhou SPL) is a subsidiary of Scientific Protein Laboratories: A Waunakee, Wisconsin, based company with a majority controlling interest.

Secondly, Changzhou SPL's products passed from China to the US amidst a startling lack of scrutiny from the companies and bodies whom should have been checking its safety. Indeed, no less than three US groups failed to scrutinize Changzhou SPL and its products.

Zero Scrutiny?

On 12 February, the US Food and Drug Administration was forced to admit that it had failed to carry out quality and safety checks on Changzhou SPL's facilities. Neither the factory nor its products were screened by the FDA. This comes in direct violation to FDA's own regulations. An FDA spokesperson blamed procedural errors for this lapse: Saying that they had been confused by the company's name.

When similarly questioned, the FDA's Chinese counterparts responded that they had not breached any regulations nor violated their duty of care on the grounds that the ingredients produced by Changzhou SPL had never been certified as being safe for use in human pharmaceutical in the first place.

Indeed, SPL had never registered Changzhou SPL as a pharmaceutical company. Instead it was listed as being a chemical company. Meaning that its products would not have been eligible to take part in the Chinese pharmaceutical certification process, let alone be certified safe for use as such. A fact which Baxter could have easily found out through basic checks with Chinese authorities. Check which Baxter should have carried out as part of their basic scrutiny process.

Questions?

In light of this information China watchers have asked several difficult questions.

• Firstly: why was Baxter purchasing pharmaceutical products that had not been certified as safe by Chinese authorities, from a company that wasn't even registered as a pharmaceutical supplier?
• Secondly: Why was the FDA not aware that Baxter was doing so, and how i had Changzhou SPL's facilities remained un inspected despite the FDA having been known that they were producing the product in question for the US market as long ago as 2004.
• Thirdly, what legitimate reason might a US company - namely SPL - have for registering a factory producing high scrutiny product as if it were a factory producing products that require a much lower level of scrutiny?

China watchers have also questioned why neither Baxter nor SPL picked up signs of contamination at their own plants prior to health concerns being raised. Voicing that, at the end of the day, it is ultimately them who have the duty of care: with the Chinese manufacturers and both US and Chinese regulators merely being steps along the road for which they were the destination.

China's View?

According to Yan Jiangying, spokesperson for the Chinese State Food and Drug Administration, while Beijing maintains a certain level of scrutiny, the final responsibility for "safeguarding the legality, quality and safety of active pharmaceutical ingredients" lies with the receiving nation, and that China could not be held accountable if foreign companies did not thoroughly check the products at their end.

SPL's view?

SPL has denied responsibility, stating the belief that, while contaminates were found in its products, it was "too early" to determine whether said contaminants were the cause of the health issues being linked to the product.

Contamination?

After complaints were made in connection to its products Baxter placed its ingredients under increased scrutiny. This during its process it was discovered that some samples of the key active ingredient: heparin, contained a "heparin-like" that made up between 5 and 20 percent of each individual sample, but which was not heparin itself. Under FDA and Baxter guidelines this level of contamination is considered significant enough to warrant termination of a batch.

Contamination was found in ingredients taken directly from SPL's Chinese plant and, crucially, in samples from that originated from the Chinese plant which had passed through SPL's own Wisconsin plant. Meaning that SPL had two opportunities to prevent contaminated products from reaching consumers.

Too Much Freedom?

At present, the US enjoys an open market import system with minimal regulation. Government scrutiny is kept to a minimum and approved supplier systems are maintained by individual companies rather than by the State. In most cases the only caviates placed on companies is that they cannot purchase goods from prescribed groups such as terrorists and money launderers, those under US/UN embargo, or from sources that are known to commit abuses such as using child or slave labor.

In practice this creates a very open import market in which American companies are largely free to source their products or components/ingredients from any Chinaside company that they deem commercially viable. However, it also means that companies may source their products and component/ingredients from companies that do not meet domestic standards and which do not comply with US workplace practices.

Greater regulation exists for pharmaceuticals, though in this case significant portions of it was either side stepped (with Baxter purchasing from a company that was never certified to produce pharmaceuticals) or otherwise not carried out.

Health Costs?

According to the Washington Post, as of March 2008, the FDA had 785 reports of side effects from patients taking the product in question, including reports from manufacturers other than Baxter. There have also been 46 reported of deaths, though only 19 of them appear to be similar to Baxter related complaints.
 

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