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Report Calls for Better U.S. Efforts to Fight Counterfeit Drugs
Date:2/13/2013

ed and there is essentially no global regulatory system to combat it; there are not even consistent definitions among countries for terms such as "substandard" and "falsified."

The word "counterfeit," for instance, is often bandied about to describe drugs that have no active ingredient or have been diluted or otherwise violated and don't meet regulatory standards. Under patent law, however, it has a very narrow meaning.

"We don't have common shared definitions. We don't have any global tracking and tracing. All of the reports by INTERPOL [International Criminal Police Organization] are anecdotal. Nobody coordinates with one another," said Gostin, professor of global health law at Georgetown University Law Center and director of the World Health Organization (WHO) Collaborating Center on Public Health Law and Human Rights, both in Washington, D.C. "As a result, we have fragmented, inconsistent data, and our report is designed to fix all of that."

The report's most ambitious recommendation, said Gostin, is asking WHO to begin a global code of practice that would create standard definitions, introduce track-and-trace systems and improve regulatory structures and capabilities all over the world.

The report also calls on the U.S. Food and Drug Administration, which sponsored the report, to act as the leader in the United States and set standards for other countries to follow.

The task is a daunting one.

"The business [of selling substandard/falsified drugs] is more profitable than the illicit drug trade," said Gostin. "It's bringing the same kinds of cartels and illegal behavior and trafficking of these medications, and it's extremely sophisticated."

Drug tampering can occur at any point in an incredibly complex supply chain. As Gostin said, "at the raw materials stage, at the manufacturing stage and even when you have good-quality drugs, they are being transported and can be delivered by the illicit trade and then diluted." '/>"/>

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