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Mr. Chairman, members of the Committee, thank you
for this opportunity to testify. I am Elizabeth Durant, Executive Director of
Trade Programs at the U.S. Customs Service. Today I would like to discuss with
you U.S. Customs’ efforts to address the rising trend of personal and bulk
importations of pharmaceutical products i nto the United States.
The Customs Service enforces over 400 regulations
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 both the FDA and DEA.
The Customs Service is concerned with three
particular aspects of the importation of pharmaceuticals: those that are
purchased through the Internet and shipped through our international mail
facilities; those carried into the United States by individuals transiting our
land borders, and imports of bulk shipments of pharmaceuticals.
The growth of the Internet has spawned a wave of
pharmaceutical purchases on-line. These purchases are most commonly sent through
the U.S. mail. We have Customs Inspectors stationed at fourteen international
mail branches at postal facilities across the United States to contend with
these shipments. These facilities are located at New York’s John F. Kennedy
Airport; Newark, New Jersey; Dulles Airport in Virginia, Chicago, Detroit,
Buffalo, Miami, Dallas, Charlotte, Honolulu, Carson Airport in Los Angeles,
Seattle, and Oakland/San Francisco.
Detecting prohibited pharmaceuticals amongst the
tens of millions of parcels passing through our mail 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.
Customs laboratories also play a critical part in
our investigations. Their expertise in analyzing everything from textiles, to
foreign oil, to food products to determine point of origin and composition is
world-renowned. We maintain fully equipped labs at the following locations: New
York; Chicago; Savannah; New Orleans; Los Angeles; San Francisco and San Juan.
In addition, we have three mobile labs to deploy at any point along our borders.
We’re confident in the forensic capability of
our labs to find discrepancies in shipments of bulk and finished
pharmaceuticals. But where we do require assistance, specifically from the Food
and Drug Administration, is in the establishment of effective national standards
for the interdiction of pharmaceuticals subject to FDA laws.
The development of such standards is critical to
Customs. To that end, we have been working closely with FDA to develop the
needed guidelines. We began by forming a joint task force to examine
pharmaceutical purchases shipped by U.S. mail. The task force set up a pilot
program in Los Angeles at the Carson mail facility. The pilot ran for thirty
days, from January 15th through February 15th of this year. During that time,
FDA detailed four full-time employees who observed first-hand the daunting
volume of packages screened by Customs every day.
Over a period of twenty-four work-days, the FDA
detained a total of 721 parcels. 677 parcels, or just over 93 percent of this
amount, were denied entry and 44, or six percent, were released for delivery by
the Postal Service. It is important to note that without the presence of FDA
inspectors, U.S. Customs would have had to detain some 3,000 packages per week,
or about 15,000 packages over an equal time span, under the existing guidelines
provided to our personnel.
In light of these results, we understand that the
FDA is revising its current policy to reflect a more practical and workable
approach. Customs is working with the FDA to devise additional means to improve
screening for these products, such as implementation of a pre-approval process
and the installation of digital cameras in mail facilities to supplement
staffing shortfalls. However, we are awaiting the FDA’s final policy before we
decide whether or not to move ahead with these initiatives.
Travelers who attempt to import pharmaceuticals
upon their return to the U.S. are also a source of concern. Again, we are
seeking the guidance of the FDA and DEA on this front. Recently, Customs
proposed a plan that that more sharply defines the current broad discretion
given to Customs inspectors to decide whether or not an importation is for a
"legitimate personal medical use". That plan is currently under review
by both agencies.
While the Customs Service is currently focusing a
great deal of effort on the interdiction of finished pharmaceuticals, we also
recognize the threat posed by the importation of bulk pharmaceuticals. In
meetings with the Pharmaceutical Security Institute (PSI) and other members of
the pharmaceutical security community, the problem of counterfeit bulk
pharmaceuticals continues to be a priority. PSI asserts the opinion that foreign
trade zones that produce finished pharmaceuticals habitually import cheap
counterfeit bulk pharmaceuticals to support their production.
In response, Customs initiated a multi-faceted
counterfeit pharmaceutical interdiction program called "Operation
Safeguard". Operation Safeguard was carried out between September and
October of 2000 at the International Mail Branches at Dulles Airport and
Oakland, California. The operation was intended to give Customs a snapshot of
the types of pharmaceutical products entering the United States. That snapshot
revealed that a vast percentage -- perhaps as much as eighty to ninety percent
-- of the pharmaceuticals that enter the U.S. via the mail do so in a manner
that violates present FDA and/or DEA requirements. Counterfeit pharmaceuticals
enter in both wholesale and retail quantities. Additional problems include
expired materials, products that have not been approved by the FDA for usage,
products made in facilities not under proper regulation and products not having
the proper usage instructions. To offer an example, our seizures included a
three thousand-tab shipment of a counterfeit drug with an expiration date of
1980 on it.
Additionally, it was found that many parcels
contained different types of pharmaceuticals that, if taken simultaneously,
could cause dangerous interactions. These products could easily be purchased by
individuals not under the direct supervision of a physician. Thus, we cannot
assume that they would be used properly.
It is important to note that after three weeks of
Operation Safeguard, the quantity of illegal and defective pharmaceutical
shipments slowed significantly.
Under the second stage of Operation Safeguard,
scheduled to begin shortly, Customs will focus on bulk pharmaceuticals processed
in various facilities around the country, including Foreign Trade Zones outside
the United States. This will help us to determine the level of counterfeiting
taking place.
In addition, our Office of Investigations is
continuing to work with the FDA and DEA to combat the sale of prohibited
pharmaceuticals via the Internet. Customs’ CyberSmuggling Center is playing a
leading role in these cases. Our efforts to date have included a successful
investigation with authorities in Thailand that closed down seven, on-line
pharmacy sites operating in that country. As a result, we saw a marked decrease
in subsequent pharmaceutical seizures from Thailand. Just last March, Thai
authorities, again using information developed by Customs, executed three search
warrants at the headquarters of an illegal Internet pharmacy marketing steroids
and Viagra.
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. We have taken many steps
to address anticipated challenges, including refinement of our targeting
approach and development of a resource allocation model to project future
staffing needs across the country. But we still face a daunting workload.
I want to thank you and the members of the
Committee for considering the Customs Service 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 inspection agencies to address the health and safety
concerns of the American people.
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