China, the FDA, and the Widening Gap in Consumer SafetyNov 3, 2008 | Parker Waichman LLP
The pharmaceutical manufacturing market is clearly being taken over by low-cost Chinese producers. For instance, China today produces about two-thirds of all aspirin and is preparing to become the world’s only global aspirin supplier.
If not for the low prices from foreign producers such as China and India, millions worldwide would likely go untreated. In the U.S., purchasing foreign generics is a way for individuals and companies to save on ever-increasing health care costs. But in the absence of proper regulation, some drugs have turned out to be ineffective or dangerous. For instance, a 2006 study revealed over half of all anti-malarial drugs sold in Southeast Asia contained no active ingredients and the World Health Organization (WHO) estimates that as many as 10 percent of pharmaceuticals sold worldwide are counterfeit or contaminated. In some poor countries, the figure is over 30 percent.
The U.S. Food and Drug Administration (FDA), the European Medicines Agency, and other government regulators rarely, if ever, inspect foreign plants and China’s drug trade is rife with counterfeiting and contamination. Take, for example, the recent debacles in which China was to blame for poisonous toothpaste, deadly pet food, lead-tainted toys, and contaminated fish; was at the heart of a deadly heparin scandal that resulted in over 80 deaths and hundreds of illnesses; and in which melamine-tainted milk formula killed four babies and sickened 54,000 children. In the heparin scandal, FDA officials admitted it should not have approved the Chinese-made heparin for sale in the U.S and that it had never inspected the Chinese plant making the drug.
The Chinese government subsidized manufacturing plant construction and has continued a trend of undercutting prices. As a result, generic drug makers in the U.S. continue to seek cheaper drug ingredients in China; last year, a mere 13 percent were made in the U.S. Over the past six years, the FDA only inspected an annual average of 15 of the 714 Chinese drug plants that export to the U.S. At this rate, the FDA will need over 50 years to visit all the Chinese plants. The FDA also seems to have a problem understanding manufacturers names, which is one reason it failed to inspect the plant that produced the deadly heparin. Someone mixed up the facility’s name and wrongly concluded the plant had been inspected.
The FDA is also operating with woefully antiquated technology, which leaves officials unclear as to names of plants, if the names are valid, and which factories require inspection, leaving investigators to consult two incompatible databases. One lists 3,000 foreign drug plants exporting to the U.S and the other 6,800. No one knows which figure is correct and no one knows for sure when the plants were last inspected, which were never inspected, where the plants are located, and what the plants produce.
This year, 18.2 million shipments of food, devices, cosmetics, and drugs are expected to enter more than 300 U.S. ports. The FDA had 454 investigators in 2007, which comes to one and a-half inspectors per port looking at millions of shipments of drugs, devices, and consumer products that entered the U.S. last year. The number of shipments are only expected to rise.