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Senate bill could open U.S. to dangerous counterfeits

Two pieces of legislation dealing with prescription drugs are currently winding their way through Congress.

The bills, however, are completely contradictory. One would create new controls for drug safety. The other would open the nation's supply chain to imported pharmaceuticals, many of which could be fake, counterfeit, or contaminated.

Is Congress for drug safety or against it? It's hard to tell.

One bill -- sponsored by Sens. Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo. -- would tighten existing laws by ordering pharmaceutical companies to monitor their drugs for safety after they have been approved by the Food and Drug Administration. This is largely in response to the recent scare surrounding Vioxx, which was voluntarily pulled from the market after serious side effects became apparent.

The other measure -- sponsored by Sens. Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine -- would open the U.S. supply chain to imported drugs from a variety of developed nations. Drugs could be imported from Canada, Europe, Australia, New Zealand and Japan.

What proponents of drug importation fail to realize, however, is that once our borders are open, most of these countries will simply become transshipment points for counterfeit drugs from anywhere, including Greece, China, India and Third World countries where fake drugs are manufactured on an industrial scale and where contamination is a serious concern.

A recent FDA inspection, for example, showed that 88 percent of the prescription-drug packages coming into the United States through the mail contained drugs that did not meet FDA standards for safety, purity, labeling, dosage, and quality.

These concerns are real. The World Health Organization estimates that up to 10 percent of today's global medicine supply is counterfeit.

Counterfeiters have discovered that this is a lucrative business: They can copy the shape and color of pills, the packaging, the holograms and the nano-markers so that even experts have trouble telling the difference between counterfeits and the real thing.

The problem already is acute in developing countries. In one recent sampling in Southeast Asia, for instance, 53 percent of anti-malaria drugs were found to be fakes. This means that unscrupulous suppliers have fed tens of thousands of malaria victims pills containing little but sugar or flour, destining many to death.

The Food and Drug Administration was created to ensure the safety of America's drug supply. What an irony it would be if Congress were to give foreign counterfeiters easy access to our markets, even as it imposes additional safety regulations on drugs that are already FDA-approved.

Grace-Marie Turner is president of the Galen Institute, a non-profit research organization focusing on free-market ideas for health reform.

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