February 9, 2008

Safe Or Not Safe: Drugs from China or Canada?

The New York Times reported recently that a subsidiary of Shanghai Pharmaceutical Group, one of the largest drug makers in China was accused of covering up contamination of some of its products resulting in serious injuries to untold number of Chinese patients. The same company is the sole supplier to the United States of the morning-after pill known as RU-486.

The FDA has not commented on the situation except to say that RU-486 was made in a separate plant that had passed FDA inspection.

Just a year or two ago the Bush Administration said that it was taking steps to forbid Americans from purchasing Canadian drugs saying that they could not guarantee their safety. Yet they allow their appointed regulators at the FDA to license the importation of drugs made in China. Is this not the height of hypocrisy?

The FDA Commissioner has stated his agency had found "thousands of examples of unapproved and potentially unsafe medicines" coming into the United States from "many countries, including from Canada" and in a subsequent news conference went further, saying there were "lots of examples of unsafe drugs coming into the United States from Canada." Yet both the FDA's director of pharmacy affairs and the Congressional Research Service support the safety of drugs from Canada, reporting that medications manufactured and distributed in Canada meet or surpass quality control guidelines set by the FDA. Comparing this, last year China executed its top drug safety official after he was shown to have accepted bribes. An example perhaps of extreme actions calling for extreme measures but then again it is China.

All the evidence and rhetoric aside, someone in the FDA came to the conclusion that drugs from China were safe while drugs from Canada were not. Does this make any sense to anyone?

The dependence by the FDA on the US Pharmaceutical industry is well documented. Many FDA senior staff leave their posts to take jobs in the same industry they were regulating. In addition, the political contributions from US Pharmaceutical companies are legendary leading to the obvious question: Who is really safeguarding the American people from contaminated drugs?

St Petersburg, Florida

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