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According to the FDA, all American drug manufacturers are inspected once every two years. For consumers of the nineteenth century that may have been a comforting fact, but today, as experts estimate that one-fifth of all generic drugs and over the counter medicines are now made overseas, consumers have every reason to take a deeper look into the safety of their drugs.

In 2008, the blood thinner heparin, made by Baxter International, was the cause of 131 deaths. Heparin is a blood thinner, most commonly used during dialysis and surgical procedures to stop blood clots. Baxter implemented a recall of its heparin products, and lab tests by the FDA showed that the products linked to the adverse reactions and deaths contained a contaminant called chondroitin sulfate, which is derived from mucous membranes in pig intestines. The contaminant was found in the heparin raw ingredient made by Changzhou SPL, a Chinese subsidiary owned by Scientific Protein Laboratories (SPL). A Congressional investigator said the contaminant cost $9 a pound compared with $900 a pound for heparin. According to an FDA report produced after the contamination, "US FDA officials had found significant deviations between procedures at the plant and US practice in the manufacture of active pharmaceutical ingredients (APIs). The report also stated that "the company had not adequately evaluated the suppliers of the crude materials, and the crude material itself, and that the manufacturing equipment was not suitable for purpose." It said that tanks to make the API were certified as clean, but "unidentified material" was found clinging to their inside surfaces." Often times, intestines are purchased with no paperwork, and therefore there'd be no way to track the source. It is then transported to consolidators, who direct the product to plants in China that manufacture heparin's active ingredient for shipment to either another trader or the finished dose to the manufacturer, in this case, Baxter. As a result, these firms are not registered as pharmaceutical companies and are exempt from regulation by the Chinese equivalent of the FDA.

In 2007, the FDA inspected only 13 of the 700 known Chinese factories making medicines for export to America. In the case of heparin, David Nelson, a Congressional investigator, told the House panel that had the FDA inspected the Chinese plant, the contamination could have been averted. FDA officials have admitted that they mistakenly failed to conduct an inspection of the Changzhou SPL plant but said that an inspection would not have been able to uncover the contamination.

According to Moises Naim, editor in chief of Foreign Policy magazine and author of "Illicit: How Smugglers, Traffickers and Copycats Are Hijacking the Global Economy, "In the 1990s governments were all about trying to maximize the volume of international trade." "I'm all for that, but I believe this decade is going to be about maximizing the quality of that trade, not quantity."

Chinese drug regulators have started becoming more proactive, particularly with the thousands of chemical companies that sell pharmaceutical ingredients without a drug license. Nonetheless, they still have a great deal of progress to make, as they adapt to the changes brought on by globalization, and intestines continue to be cooked in unregulated workplaces. Since supply chains often pass through more than one country, there is no government agency with the power to oversee it all.

As much as the Chinese are responsible, America as a buyer, and the FDA as our voice, needs to better regulate foreign drugs coming into the United States since the terrible ordeal surrounding heparin revealed some serious deficiencies in the regulatory process.

 
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