China is marketing itself as an international outsourcing hub for life sciences and has become the largest vaccine manufacturing country in the world, capable of producing 41 vaccines. China already has more than 400 biopharmaceutical companies of different ownerships and more than 20,000 biotech research scientists.
That number is increasing as the Chinese government is steadily repatriating its scientists who were trained in the United States. The hai gui, skilled Western-trained Chinese returnees who studied and worked in the U.S. for many years, acquiring academic and commercial experience, are now going back to China to take important positions at salaries that are one-third to one-fifth of U.S. salaries.
An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the United States are imported, and an estimated 40 percent of finished drugs are made in foreign countries. The Chinese drug agency does not even oversee the making of pharmaceutical raw materials, called intermediates, which are the building blocks for active pharmaceutical ingredients.
The U.S. Food and Drug Administration is slated to inspect only 13 of China's 714 drug firms, 1.8 percent, this year. U.S. drugmakers are inspected at least once every two years, but there is no such requirement about imports, and Government Accountability Office spokeswoman Marcia Crosse admitted that 13 years can pass before a foreign manufacturer is visited even once.
The Associated Press reported that when the FDA does visit foreign plants, its inspectors can make "sometimes harrowing findings."
Even when Chinese manufacturers are inspected, our FDA inspectors rely on the companies for translators, and U.S. firms are required to authorize a Chinese official to serve as its legal representative. One U.S. CEO said, "Every piece of information you get is suspect."
At the Cambridge Healthtech Drug Development in China conference in Philadelphia in September, Chinese speakers bragged that China offers opportunities to lower costs for preclinical and clinical drug development activities. The cost of doing preclinical studies and clinical trials in China is about 20 percent to 60 percent of U.S. costs and can be many months faster, so U.S. multinationals follow the money.
But clinical trial applications are risky because there is no well-defined process, and Chinese regulations mean little because everything is ultimately decided on a local level. How can we know that the drugs in our medicine chest are safe?
Phyllis Schlafly is a national leader of the pro-family movement, a nationally syndicated columnist and author of Feminist Fantasies.
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