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USDA Recommends Measures to Combat Counterfeit Drugs - 2004-02-19

The U.S. Food and Drug Administration is recommending a number of new measures to protect American consumers from counterfeit drugs that could endanger their health. U.S. health officials say recent years have seen an increasing number of FDA counterfeiting investigations and ever more sophisticated techniques for making fake pharmaceuticals. Counterfeit drug products may possess inactive, incorrect, or contaminated ingredients; improper dosages, or the wrong potencies.

U.S. Secretary of Health and Human Services Tommy Thompson told reporters although the United States has one of the safest drug industries in the world, counterfeit drugs are a growing problem for consumers and a danger to public health.

"The counterfeiting of currency and consumer products are common problems, but the counterfeiting of medication is a particular, insidious practice," said Mr. Thompson. "Counterfeiters not only defraud consumers, they also deny ill patients the therapies that can alleviate suffering and save lives."

The new report is the work of a task force assembled by FDA Commissioner Mark McClellan. They consulted a number of different groups for advice on fighting drug counterfeiting. The groups included security experts, law enforcement officials, technology developers, manufacturers, retail and wholesale drug vendors, consumer groups, and the general public.

The report says there's no one clear way to stop drug counterfeiting, but there are a number of methods that can be combined to offer better overall protection for the consumer.

The FDA's recommendations encompass six areas: securing the drug product itself; tracking the movement of the drug through the distribution chain; improving regulatory oversight; increasing penalties for counterfeiters; raising public awareness of the dangers of counterfeit drugs; and getting international cooperation to fight the problem.

The report highlights a type of technology known as "radio frequency identification" as a way to track a drug's progress from manufacturer to consumer. A tiny electronic tag and antenna are placed behind the label of a drug container so its whereabouts can be tracked from start to finish, a much more trustworthy system than keeping records on paper. FDA officials say the technique could be used in drug distribution by the year 2007. The report also recommends such authentication technologies as holograms, color-shifting inks, or chemical markers embedded in a drug or its label, just as they are used in paper money to prevent counterfeiting.

FDA Commissioner Mark McClellan says increased criminal penalties should provide an added deterrent for those who would produce counterfeit drugs. "Today the criminal penalties for counterfeiting are significantly less than other types of crime," he says. "Counterfeiting a prescription drug label is punishable by up to ten years in prison. Counterfeiting the drug itself is punishable by a maximum of only three years in prison."

Mr. McClellan said the FDA will be encouraging companies in the drug supply chain to step up security practices, and hopes to strengthen and speed up its MedWatch alert system, a network where doctors and consumers can report problems with drugs and other medical products. MedWatch disseminates the information it gathers through a number of medical, consumer, and trade organizations.

"Remember that counterfeit drugs are a global challenge today," he says. "In some countries more than half the drugs are counterfeits and virtually all countries have face sophisticated counterfeit operations in recent years."

Mr. McClellan says the FDA plans to work with international agencies such as Interpol and the World Health Organization to combat drug counterfeiting on a global basis, since, with Internet and mail order marketing, foreign counterfeits could still cross U.S. borders.