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U.S. Customs & Border Protection

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Source: Merck, Chinese Counterfeit Drugs, 2006
By The Numbers

According to the U.S. Department of Homeland Security, the Department's components saw an 83 percent increase in seizures of counterfeit goods during fiscal year (FY) 2006.  The 2006 activities continued a significant upward trend in the number and value of seizures of counterfeit goods, making it the most productive year in the department's history. The department's U.S. Customs and Border Protection (CBP) and Immigration and Customs Enforcement (ICE) components made more than 14,000 seizures of counterfeit goods worth more than $155 million, which represents a 67 percent increase from the year before.

On the Record

Officials for the U.S. Customs and Border Protection recognize the gravity of the counterfeit drugs problem. Read their thoughts from Congressional testimony below:

“We also estimate that 10 million people cross the land border annually carrying unapproved products. . . During the course of the operation there were several troubling instances of returning U.S. residents receiving different medications than the ones they thought they were being prescribed. . . . [W]e have found the volume of pharmaceuticals shipped through international mail to be enormous. We have also found a significant number of these products do not contain an active pharmaceutical ingredient, but merely contain substances such as starch or sugar. Other problems include expired materials, unapproved products, improper use instructions and products made in facilities not under proper regulation.”

- Excerpt from July 14, 2004 testimony of Elizabeth G. Durant, Executive Director of Trade Compliance and Facilitation, Office of Field Operations at the Bureau of Customs and Border Protection (CBP) before the Senate Judiciary Committee.

“Millions of packages come through mail and express courier facilities each year. Thousands of packages, particularly in the mail, are found to contain illegal and unapproved pharmaceuticals. We also estimate that 10 million people cross the land border annually carrying the same unapproved products.”

“We have also found that a significant number of these do not contain an active pharmaceutical ingredient, but merely substances such as starch or sugar. Other problems include expired materials, unapproved products, improper use instructions, and products made in facilities not under proper regulations. The vast majority of pharmaceuticals that enter the U.S. via the mail do so in a manner that violates present FDA requirements.”

- Excerpts from June 24, 2003 testimony of Elizabeth Durant, Executive Director of Trade Compliance and Facilitation at the Bureau of Customs and Border Protection (CBP) before the House Energy and Commerce Committee, Subcommittee on Oversight and Investigations.

“During a recent phase of Operation Safeguard that took place at two international mail branches, 31 parcels containing 52 different types of questionable pharmaceuticals underwent intensive chemical analysis. The analysis of these products showed that eight of the so-called pharmaceuticals, or 15 percent, contained no identifiable active ingredient, and 18 contained a substance that is regulated under the Federal Controlled Substances Act.”

- Excerpts from July 9, 2002 testimony of Elizabeth Durant, Executive Director, Trade Programs, U.S. Customs Service, before the Senate Special Committee on Aging.

“Counterfeit pharmaceuticals enter in both wholesale and retail quantities. Additional problems include expired materials, products that have not been approved by the FDA, products made in facilities not under proper regulation, and products not having the proper use instructions. To offer an example, one seizure included a 3,000-tab shipment of a counterfeit drug with an expiration date of 1980.”

“You can see the kinds of drugs that come in through the mail. They are not even in bottles many times, just loose in paper. We have counterfeit drugs. We have gray-market drugs. We have prohibited drugs and we have unapproved drugs. And this is a situation that is pretty much replicated around the country.”

-Excerpts from June 7, 2001 testimony of Elizabeth Durant, Executive Director, Trade Programs, U.S. Customs Service, testimony before House Energy and Commerce Committee, Subcommittee on Oversight and Investigations.
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