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Chinese
cough medicine filled with poisonous anti-freeze kills 89 children in Haiti.
Counterfeit imported
anti-seizure drugs suspected of killing several epileptics in the U.S.
Thousands of drugs
sold to Americans through the mail from foreign internet pharmacies made in
filthy, vermin-infested labs.
Powerful, deadly
painkillers declared and brought from Mexico or Canada into the U.S.
People who die or
are injured by self-medicating with prescription drugs of unknown quality,
unknown dosage levels, unknown impurities, unknown side effects, and unknown
interactions.
These are examples
of the dangers of many imported pharmaceuticals.
Drum-by-drum,
parcel-by-parcel, consumer-by-consumer, imported pharmaceuticals are arriving
from unapproved sources, border pharmacies, and even bathtubs or dirty kitchens.
Many of these products threaten the public health.
The problem of
counterfeit drugs is not just a phenomenon of the developing world. Our
lucrative market and ineffective import controls are increasingly making the
United States an attractive target for drug counterfeiters and diverters. Last
month, three counterfeit prescription drugs were found in the shelves of
pharmacies of several states. It is not known whether these fake drugs were made
in the United States or overseas. But such a cluster of counterfeits has not
been seen for years in this country.
This public health
threat of imported pharmaceuticals is getting worse virtually by the day. More
Mexican border pharmacies. More foreign internet pharmacies. More drugs in the
international mail. More pharmaceutical ingredients from overseas. More people
in desperate straits who seek cheaper medicines from abroad. More hucksters,
criminals, snake-oil salesmen, slick-willies, and con artists who prey upon
consumers, distributors, and manufacturers.
Meanwhile, our
federal agencies responsible for keeping out dangerous drugs are no longer
maintaining the pretense that the problem can be controlled. For example, in its
December 2000 Performance Plan Summary, the Food and Drug Administration stated:
"The Agency is unable to assure the U.S. public that it can prevent unsafe
imports from entering the country." The data from a recent joint project
between the FDA and the U.S. Customs Service show only a small fraction of drugs
in the mail ever gets examined by the FDA and even a visual examination of these
products cannot detect the full extent of counterfeit or substandard product. On
one side, the FDA and the Customs Service are overwhelmed by a flood of
commercial shipments of imported bulk ingredients. On the other, these agencies
are confronted by thousands of individuals with personal imports, an army of
ants overrunning the system.
Unless we find new
effective solutions soon, I believe it is only a matter of time that these
uncontrolled imported drugs will lead to an epidemic here that will kill, maim
or severely sicken people. Fortunately, this hearing is an important start in
reaching solutions. In so doing, we won’t lose sight of the real-life problems
seniors and other Americans are facing with high drug prices. I know many
Americans are resorting to getting what they believe -- or have been told to
believe -- are cheaper versions of U.S. drugs in Canada and Mexico. In many
cases, these foreign drugs are not cheaper and they are not the same as U.S.
drugs. But the problem of high drug prices and prescription drug coverage is one
that we will deal with directly in this Committee. While we tackle
affordability, we will pursue safety solutions that target the greatest health
risks, and at the same time, minimize disruption and risks for those who feel
they must avail themselves of pharmaceuticals in Canada and Mexico.
I congratulate the Subcommittee
Chair, Congressman Jim Greenwood, for this essential hearing. He has invited an
impressive array of expert witnesses to assess the issues and to discuss
proposals and recommendations. I look forward to hearing the testimony,
examining the evidence, and getting some answers.
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