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Looks Can Be Deceiving (and Costly): The Legal Implications of Counterfeit Products to a Pharmaceutical Manufacturer

By Alan Minsk and Richard Gardner

The World Health Organization has estimated that drug counterfeiting affects 5-8% of all drugs, representing approximately $10-$15 billion to the U.S. pharmaceutical market alone. The Food and Drug Administration has estimated that approximately 10% of the drugs in worldwide distribution are counterfeit, with most being sold in developing countries. Not surprisingly, the most commonly counterfeited drugs are those with the largest sales, as well as drugs with high profit margins and drugs that are easier to counterfeit.

The FDA has stated that, in recent years, counterfeiting has moved into the area of finished pharmaceuticals, more so than to the counterfeiting of bulk drug ingredients. Moreover, with the increase in sales of drugs over the Internet, the agency is becoming even more concerned about the prevalence of drug counterfeiting, and the increasing ease by which counterfeited drugs may be distributed into the marketplace.

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