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When the subject is
pharmaceuticals, people usually talk about the high prices. But today’s
hearing will show we still also need to pay attention to safety.
We in Congress are
acutely aware of the problem of high prices of prescription drugs in the U.S.
About a third of our elderly are without access to adequate prescription drug
coverage. Many Americans, especially our senior citizens on fixed incomes,
struggle to balance their finances to pay for prescription drugs that help keep
them alive or maintain a decent quality of life. Out of these desperate
circumstances, some cash-strapped Americans are traveling to border pharmacies
to obtain what they believe are cheaper versions of the U.S. drugs in Mexico or
Canada. Some Americans are ordering drugs through the mail from foreign-based
internet pharmacies to obtain prescription drugs without real physician
supervision. Perhaps it is a measure of the success of the high regulatory and
industry standards in the U.S. that many Americans in their pursuit of
affordable medicine appear to take the safety of prescription drugs for granted.
However, what we
will learn today, is that drugs obtained from outside the United States without
proper controls pose real risks to American consumers. This hearing will examine
these risks by focusing on four particular areas of continuing concerns over
imported pharmaceuticals: controlled substances from Mexican border pharmacies,
prescription drugs ordered from foreign-based internet pharmacies, counterfeit
or substandard bulk drugs, and international pharmaceutical counterfeiting and
diversion. In all of these areas, there is a mass of evidence from studies and
investigations that shows the safety risks. I understand that some Americans who
feel desperate are willing to take risks purchasing prescription drugs from a
border pharmacy or a foreign-based internet pharmacy. Under current
circumstances, I don’t want to interfere with seniors who are desperately
looking for cheaper buys. But I feel sure that many senior citizens don’t want
to see their grandchildren harmed by controlled substances from border
pharmacies or drugs obtained without a prescription from some phantom, foreign
website.
As representatives
in the U.S. Congress who enacted the laws to protect consumers from the dangers
of unapproved, misbranded or adulterated drugs, we have a responsibility to
raise public awareness about these risks, and to help minimize these risks
through public education, working with the Administration to take sensible and
restrained administrative actions, and passing new legislation, if necessary. I
want Americans to get cheaper prescription drugs in the U.S. I don’t want any
Americans hurt in trying to get cheaper drugs from abroad.
Prescription drugs
are highly regulated and require physician supervision for a reason. Drugs are
inherently dangerous unless they are manufactured precisely and properly, dosed
correctly, and used appropriately. When used under competent physician care and
in accordance with instructions, drugs are life-saving. But there is often not a
large margin between life and death.
For these reasons
and others, it is illegal under the federal Food, Drug and Cosmetic Act to
import misbranded, adulterated or unapproved prescription drugs. However, in a
bow to common sense, the FDA decided over 40 years ago not to strictly enforce
the Act against U.S. residents who obtained unapproved foreign-made prescription
drugs to treat sickness or injury while on travel in a foreign country. Over
time FDA created a guidance on personal importation of prescription drugs that
in effect says for reasons of enforcement priorities and limited resources, FDA
will not enforce the Act against U.S. residents who bring in a 90-day supply of
foreign drugs for medical purposes either from traveling abroad or through mail
delivery.
With regard to
personal importation, the Subcommittee is particularly concerned about two
areas: (1) controlled substances obtained at the land border pharmacies
(especially Mexico), and (2) prescription drugs obtained through mail
deliveries. Controlled substances represent the most dangerous class of
prescription drugs, because they can be addicting, and even deadly when used
non-medically. Because of their high abuse potential, these prescription drugs
are scheduled under federal law requiring additional regulation.
In 1998, in response
to concerns about the personal importation of controlled substances at the
Mexican land border, the Congress passed an amendment to the Controlled
Substances Import and Export Act. That amendment required a valid U.S.
prescription for any personal import of a controlled substance that was more
than 50 dosage units. Perhaps sensing that this 50-dosage unit law represented
an opportunity for clearer guidance to overwhelmed Customs border inspectors,
some in the Customs Service interpreted the 1998 amendment as justifying an
enforcement practice that would allow personal imports of 50 dosage units or
less for each drug per border crossing.
Unfortunately, it
appears from the Committee staff ‘s investigations at the Southwest border
crossings, internet postings and chat rooms, and other information, that this
50-dosage unit policy has become well-known and exploited by drug traffickers
and individuals interested in bringing in controlled substances for abuse
purposes. One can even find controlled substances blister-packed in 50-dosage
unit amounts.
Although we lack
comprehensive and definitive data on controlled substances importation, it is
reasonable to observe that the 50-dosage unit policy is contributing to a
national drug abuse problem. Consider the massing of pharmacies that provide
easy access to controlled substances at our borders. For example, in Tijuana,
Mexico, there are estimated to be up to 1700 pharmacies, up from 500 pharmacies
in 1997. In contrast, twenty miles north, in San Diego, California, there are
only 125 pharmacies. In December 2000, the Texas Commission on Alcohol and Drug
Abuse noted that a major substance abuse problem is Mexican pharmacies selling
many controlled substances to U.S. citizens who declare these drugs and bring in
personal import amounts into Texas. We will hear testimony from Landon Gibbs of
the Virginia State Police about the emerging abuse problem of one controlled
substance called oxycontin, a powerful painkiller drug with a 12-hour
time-release targeted by drug traffickers because of the huge narcotic rush when
the drug is crushed and snorted. Although the vast majority of abuse cases
involves drug unlawfully obtained within the U.S., recent investigations
indicate some oxycontin is coming from Mexico, probably some through personal
importation from Mexico.
In response to
the Committee’s bipartisan concerns, several federal agencies - the Office of
National Drug Control Policy, the Drug Enforcement Administration, the FDA, and
the Customs Service -- have been meeting to develop recommendations for
strengthening federal policy in the area of personal imports of controlled
substances. I understand that the Drug Enforcement Administration has developed
a proposal that we hope to be a vast improvement over the status quo. I look
forward to hearing about this proposal and discussion of this issue with our
witnesses. I want to note my particular appreciation to Congressman John Dingell,
the Ranking Member of the Full Committee, for forcefully raising this important
public safety and public health issue.
Mail deliveries
represent another personal importation problem. In the last few years,
especially with the explosion of internet pharmacies, personal mail deliveries
of prescription drugs have skyrocketed, overwhelming the Customs Service and the
FDA. In January-February 2001, the FDA conducted a pilot program with the
Customs Service on mail deliveries of prescription drugs at the international
mail facility at Los Angeles. Typically, the Customs Service screens the parcels
by sight and through an x-ray machine. Customs sets aside the parcels of
prescription drugs for an FDA officer to review. The FDA officer usually comes
for a half-day, once a week, to review the parcels. Under the pilot program, two
FDA officers were on-site, five-days a week, processing the set-aside parcels
for 30 days. Even under these ideal circumstances, FDA was only able to review
1,908 parcels out of a possible 16,000 or only about 12% of the likely universe
of prescription-drug parcels. Out of these parcels, FDA detained about 700 out
of the 1900, because they appeared violative. Out of the 700 detained parcels,
554 were ultimately refused entry, usually because it was determined that the
mail order lacked a valid prescription. A large percentage of the 554 refused
entries were shipped via a South Pacific republic called Vuanuatu and New
Zealand. It is believed that those shipments were from a single source currently
under criminal investigation. It is important to note that the parcels that FDA
is unable to review are released. Extrapolating from the pilot program data
nationally, it is estimated that up to 200,000 parcels per month could be coming
in unreviewed.
In September 2000
the Customs Service conducted a study called Operation Safeguard of two U.S.
facilities showed that none of the pharmaceuticals examined were reimportations
of U.S. manufactured drugs. None of the 512 parcels fulfilled all the personal
use requirements. Only three parcels had evidence of medical supervision and ten
percent of the parcels analyzed contained no active ingredients.
What are the dangers
of the prescription drugs that are allowed in? We will hear of one tragic story
from Edwin and Helen Rode. Their son, Todd, was found dead on November 16, 1999.
They believe his death was a direct result of prescription drugs obtained
through the mail from a foreign-based internet pharmacy. Although Todd was being
treated for severe depression, he ordered a combination of prescription drugs
without any physical examination by a physician. The medical examiner’s report
states that some of these drugs were ingested by Todd at the time of his death.
I want to thank Reverend and Mrs. Rode for testifying at this hearing. It takes
a lot of courage to relate their painful experience publicly. But by stepping
forward, they may help save some lives.
In addition to this
tragic story, a joint U.S. and Thai Customs enforcement effort in March 2001,
called Operation Chokepoint, shows what may lie behind some of these
foreign-based internet pharmacies. This operation targeted thousands of illegal
pharmaceutical shipments of Viagra and steroids exported from Thailand to the
U.S. via mail from a notorious internet pharmacy to US customers. The results of
the operation showed a British national still under treatment for hepatitis
operating an illegal pharmaceutical processing center in his residence,
processing the drugs in a filthy, vermin-infested kitchen with the assistance of
a Thai prostitute. In some instances, the British national added cheap vodka to
bulk steroid or Viagra powder to form a paste which would evaporate during
shipment.
Just a few weeks
ago, Congressmen Deutsch, Stupak, and I visited the international mail facility
near Dulles Airport. We viewed firsthand the processing of prescription drug
parcels. Here is one example. Many of these parcels contained prescription drugs
that had been withdrawn from the US market, highly dangerous combinations of
drugs for one person, drugs lacking labeling or instructions, drugs masked as
something else or not in its original container. The overwhelming numbers of
prescription-drug parcels is a daunting challenge, that would require a
tremendous and unrealistic increase in personnel and resources. Even if such an
increase occurred, the legal requirements in processing parcels impose massive
burdens. Clearly, a serious policy decision needs to be made and new procedures
considered. In response to a bipartisan inquiry in this area, the FDA in
consultation with the Customs Service has devised several proposals for
improving the public health protections related to mail deliveries. These
proposals and a recommendation are pending with the Secretary of Health and
Human Services. I look forward to working with the Secretary to move in a
reasonable and responsible way.
In the area of
personal importation, individuals usually are in some way assuming some risk.
But what about unsuspecting consumers who are getting drugs within the U.S.
healthcare delivery system? Are there any risks to them of getting counterfeit
or substandard drugs? Over the last decade, there has been a surge in shipments
of bulk drugs or "active pharmaceutical
ingredients"
(APIs) from overseas. About 70-80% of brand-name APIs and 90-95% of generic APIs
are made overseas. Any foreign firm that makes bulk ingredients for the U.S.
market must be inspected by the FDA. This surge of imports has overwhelmed FDA
and outstripped its inspectional resources. Last year, the FDA advised the
Committee that 242 foreign API firms appeared to have shipped misbranded drugs
to the U.S. in 1999 but were never inspected by the
FDA.
Even for those firms
that have been inspected, the Subcommittee’s past investigations have shown
how the approved foreign firm in a few cases becomes the front for counterfeit
or unapproved bulk drugs shipped to the U.S. Sophisticated counterfeiting in the
chemistry and documentation of the drugs is difficult to detect. Last year’s
Subcommittee hearing revealed a
link between serious
reactions in a 155 American patients from an antibiotic and a Chinese bulk drug
manufacturer. The FDA committed to a number of strategies for handling imported
counterfeit and unapproved drugs. The Subcommittee will want to learn how the
FDA has approved its intelligence gathering on counterfeiting. We will want to
find out how the FDA plans to use its personnel and equipment to better monitor
U.S. ports of entry. We are also interested in what, if any, security measures
FDA has added and what additional resources may be needed.
Recent events in the
U.S. pharmaceutical market have justified the Subcommittee’s vigilance over
counterfeiting. Last month, three different drug companies reported finding
counterfeit versions of their drugs in the U.S. One bogus drug was for treating
patients with AIDS wasting disease, a particularly vulnerable population.
Another counterfeit purported to be a growth hormone that contained human
insulin, which could be deadly to some individuals. The third fake drug was
labeled as an anti-infective that had no active ingredient. So far, there do not
appear to be any life-threatening adverse events linked to the counterfeits, but
they did make their way to pharmacy shelves.
Overall, I believe
that prescription drugs in the U.S. are extremely safe. But it is important to
remember that the risk is not zero. There is no magic force-field that protects
the U.S. from imported counterfeit or diverted product. We must be aware of the
latest threats in the global pharmaceutical market and deal with them. We are
very fortunate to have some of the leading experts on pharmaceutical
counterfeiting and diversion before us today. Their testimony should greatly
assist the Subcommittee’s understanding of the issues.
I want to thank the
Chairman of the Energy and Commerce Committee, Congressman Billy Tauzin, for his
support of this investigation and hearing about imported drugs. I also want to
thank the Ranking Minority Member of the Subcommittee, Congressman Peter
Deutsch, for his support and interest in this investigation. I likewise express
my appreciation to Congressman Bart Stupak for his participation and
contribution to the Subcommittee’s efforts.
I am well aware of the hard work
and the preparation for these hearings by all of the witnesses. On behalf of the
Subcommittee, I thank you and look forward to your testimony.
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