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A Growing Problem - China's Control of Pharmaceuticals and Ingredients

You can add to the growing list of threats to our National security from China the fact that Chinese companies dominate the production of antibiotics and hold major share of the worldwide sales of many vitamins, antibiotics, enzymes, and painkillers. So, there is more to the "China problem" than just the cyber attacks on Oak Ridge National Laboratory, theft of intellectual property or the sale of restricted technologies, or the sale of tainted toothpaste, toxic toys and tainted pet food, all from China.

Aside from the National security aspect of this, China's drug manufacturing industry is characterized by the lax manufacturing standards, controls or enforcement, and corruption. Yet, in the last five years, Chinese pharamceutical exports to the United States have doubled (China’s $65 billion pharmaceutical industry is growing at an annual growth rate of 24 percent in the first eight months of 2007). The U.S. has licensed over 700 manufacturing plants in China that make ingredients for such products as vitamins, antibiotics, enzymes and painkillers (China makes 1/3 of the world’s acetaminophen).

Another example is Cipro Among the critical areas of concern is that Chinese companies now control key ingredients of Cipro (used to counter exposure to Anthrax and previously protected by patents until 2004) and doxycycline. These key ingredients are now produced generically in China and India with limited oversight from the FDA.

With all of the concern over the cost of pharmaceutical products, there has been an on-going debate about drug importation. People travel to Canada and Mexico to buy cheap drugs and generic versions of well-known brands. The problem is that without FDA oversight, quality, as well as authenticity of the products and their ingredients themselves, is a serious concern. Each year since 2003, awareness of the threats posed by counterfeit or low quality drugs has risen. The World Health Organization estimates that counterfeit drugs represent $75 billion globally in 2010, an increase of more than 90% from 2005. That doesn't include products that are manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases.

The health and safety of the American patient is weighed against the cost of pharmaceutical products. We face a growing crisis. China is just a part of it the problem.