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   H3'ed 3/12/15

FDA Complaint Filed to Require Country of Origin Labeling on Prescription Drugs

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Chinese Drugs

China, unlike India, has blocked U.S. efforts to send FDA inspectors. "China is the source of some of the largest counterfeit manufacturing operations that we find globally," said John P. Clark, Pfizer's chief security officer. Prescription drugs are pouring in from China, but U.S. regulators are not ensuring their quality, safety or proper labeling.

Federal regulators have inspected only a fraction of the hundreds of Chinese factories making prescription drugs for the U.S. market, a recent report from the Government Accountability Office says.

Consumers can't tell where imported drugs and dietary supplements are made because country-of-origin labeling laws are not being enforced.

Chinese officials and businesses defend the quality of their products and say their defect rates have been decreasing. But problems with Chinese products keep cropping up -- such as a recent case of Viagra contaminated with a drywall ingredient.

Leo Hepner, an international consultant on food and dietary supplement ingredients, said U.S. consumers did not realize that China now supplied most of the world's vitamin C and antibiotics, along with substantial amounts of other drugs and supplements.

Foreign drug and supplement plants producing for the U.S. market are supposed to meet FDA standards. But the GAO report said the FDA over the past few years had checked only 12 percent of the hundreds of Chinese plants producing pharmaceutical ingredients or finished products for the U.S. market.

The FDA did get to 52 of the plants in China in one year the report said, but that meant it had yet to visit 811 of the 920 Chinese facilities it is supposed to oversee. At the current inspection rate, it will take the FDA more than 15 years to get to the rest of China's plants.

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Chairman, Made in the USA Foundation, economist and lawyer, author of ten books and hundreds of articles.
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