Drug Safety or Drug Danger

Grace-Marie Turner

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-MA) and Michael Enzi (R-WY) -- would tighten existing laws by ordering pharmaceutical companies to continue 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-ND) and Olympia Snowe (R-ME) -- 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% 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.

Currently, pharmaceutical companies are required to protect the supply chain, starting with the manufacturing plant, through distribution channels, and on to pharmacists, physicians, and patients.

But if suppliers can legally introduce other drugs into this supply chain, it will be impossible for a mother to tell if the medicine she is giving her child came from an FDA-approved and inspected facility in Pennsylvania or from an unsanitary plant in Bangladesh. Not even your doctor will be able to tell if the drug is safe.

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.

Drug counterfeiters can make more money and face less of a threat of criminal action by counterfeiting medicines rather than currency, or even selling heroin or cocaine.

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.

Even in the United States, at least 400 deaths have been attributed to poisonous cough syrup.

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 turn this upside down by giving 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
Copyright 2007. All Rights Reserved.

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