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Prepared Witness Testimony The House Committee on Energy and Commerce
A System Overwhelmed: The Avalanche of Imported, Counterfeit, and Unapproved Drugs into the U.S.
Subcommittee on Oversight and Investigations
Ms. Elizabeth Durant
Mr. Chairman, members of the Committee, thank you for this opportunity to testify. I am Elizabeth Durant, Executive Director of Trade Compliance and Facilitation at the Bureau of Customs and Border Protection (BCBP). Today I would like to discuss with you BCBP efforts to address the ever-increasing trend of personal and bulk importation of pharmaceutical products into the United States. Although the main focus of the BCBP is to protect the United States from terrorist attacks, BCBP also enforces over 400 requirements for more than 40 other federal agencies at U.S. borders. These include the laws that prohibit the importation of illegal or unapproved pharmaceuticals that fall under the jurisdiction of the Food and Drug Administration, or FDA. The BCBP is concerned with three particular ways that pharmaceuticals are imported: those that are purchased through the Internet and shipped through our international mail or express courier facilities; those carried into the United States by individuals transiting our land borders; and bulk shipments of adulterated or counterfeit pharmaceuticals. Millions of packages come through mail and express courier facilities every 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. A disturbing trend is the increase in bulk shipments through the mail indicating that these products could be making their way to pharmacy shelves. Detecting prohibited pharmaceuticals among the tens of millions of parcels passing through our facilities each year presents a massive challenge. Our limited resources require a risk management approach, with which we utilize advance intelligence, records of past seizures, and other factors to locate packages that present the most significant threat. We work in cooperation with the FDA on this important function. BCBP laboratories help us find discrepancies in shipments of bulk and finished pharmaceuticals. FDA establishes effective national standards for the interdiction of pharmaceuticals subject to FDA laws. Based on an operation nicknamed "Operation Safeguard" that we have carried out over the last couple of years, we have found the volume of pharmaceuticals shipped through international mail to be enormous. We have also found that a significant number of these do not contain an active pharmaceutical ingredient, but merely contain substances such as starch or sugar. Other problems include expired materials, unapproved products, improper usage instructions, and products made in facilities not under proper regulation. The vast majority of the pharmaceuticals that enter the U.S. via the mail do so in a manner that violates present FDA or other requirements. Additionally, we have found that many parcels contained different types of pharmaceuticals that, if taken simultaneously, could cause dangerous interactions. Individuals not under the direct supervision of a physician could easily purchase these products. Thus, we cannot assume that these products would be used properly. It is important to note that after three weeks of one phase of Operation Safeguard, the quantity of illegal and defective pharmaceutical shipments slowed significantly. During a 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 analyses of these products showed that 8 of the so-called pharmaceuticals or 14 percent contained no identifiable active ingredient and 23 (or 40 percent) contained a substance that is regulated under the Federal Controlled Substance Act. Additionally, during this phase of the operation it was found that large parcels of fake or gray market pharmaceuticals are being split into different mail shipments but arrive at the same address. Accordingly, there is a possibility that state side pharmaceutical distributors could be using these products as a source of supply. This summer, BCBP intends to conduct "blitz" operations at four International Mail Branches. BCBP scientists will work with inspectors to target, examine, and test packages containing pharmaceuticals. This operation will enable BCBP to evaluate the type, volume and quality of imported medication. It is clear that this remains an overwhelming problem and BCBP is working cooperatively with the FDA to improve our enforcement efforts in this area including efforts to address the immediate return of imported pharmaceuticals and travelers who attempt to import pharmaceuticals upon their return to the U.S. From an overall perspective, a spiraling volume of goods at our borders has put immense pressure on our ability to enforce the nation's laws while facilitating international trade and protecting the borders against the threat of terrorism. Although we have taken some positive steps, successfully identifying and handling imported pharmaceuticals presents a daunting task for BCBP. I want to thank you and the members of the committee for considering the BCBP in your review of the importation of personal and bulk pharmaceuticals. This is an issue that speaks directly to our mission. We will continue to make every effort possible to work with the Congress and our fellow agencies to address the health and safety concerns of the American people.
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