Internet Pharmacies
Some Pose Safety Risks for Consumers and Are Unreliable in Their Business Practices
Gao ID: GAO-04-888T June 17, 2004
As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase them. However, the global nature of the Internet can hinder state and federal efforts to identify and regulate Internet pharmacies to help assure the safety and efficacy of products sold. Recent reports of unapproved and counterfeit drugs sold over the Internet have raised further concerns. This testimony summarizes a GAO report: Internet Pharmacies: Some Pose Safety Risks for Consumers, GAO-04-820 (June 17, 2004). GAO was asked to examine (1) the extent to which certain drugs can be purchased over the Internet without a prescription; (2) whether the drugs are handled properly, approved by the Food and Drug Administration (FDA), and authentic; and (3) the extent to which Internet pharmacies are reliable in their business practices. GAO attempted to purchase up to 10 samples of 13 different drugs, each from a different pharmacy Web site, including sites in the United States, Canada, and other foreign countries. GAO assessed the condition of the samples it received and forwarded the samples to their manufacturers to determine whether they were approved by FDA, safe, and authentic. GAO also confirmed the locations of several Internet pharmacies and undertook measures to examine the reliability of their business practices.
GAO obtained most of the prescription drugs it sought from a variety of Internet pharmacy Web sites without providing a prescription. GAO obtained 68 samples of 11 different drugs--each from a different pharmacy Web site in the United States, Canada, or other foreign countries, including Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from which GAO received samples required a patient-provided prescription, whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of Canada provided a prescription based on their own medical questionnaire or had no prescription requirement. Among the drugs GAO obtained without a prescription were those with special safety restrictions and highly addictive narcotic painkillers. GAO identified several problems associated with the handling, FDA-approval status, and authenticity of the 21 samples received from Internet pharmacies located in foreign countries outside of Canada. Fewer problems were identified among pharmacies in Canada and the United States. None of the foreign pharmacies outside of Canada included dispensing pharmacy labels that provide instructions for use, few included warning information, and 13 displayed other problems associated with the handling of the drugs. For example, 3 samples of a drug that should be shipped in a temperature-controlled environment arrived in envelopes without insulation. Manufacturer testing revealed that most of these drug samples were unapproved for the U.S. market because, for example, the labeling or the facilities in which they were manufactured had not been approved by FDA; however, manufacturers found the chemical composition of all but 4 was comparable to the product GAO ordered. Four samples were determined to be counterfeit products or otherwise not comparable to the product GAO ordered. Similar to the samples received from other foreign pharmacies, manufacturers found most of those from Canada to be unapproved for the U.S. market; however, manufacturers determined that the chemical composition of all drug samples obtained from Canada were comparable to the product GAO ordered. Some Internet pharmacies were not reliable in their business practices. Most instances identified involved pharmacies outside of the United States and Canada. GAO did not receive six orders for which it had paid. In addition, GAO found questionable entities located at the return addresses on the packaging of several samples, such as private residences. Finally, 14 of the 68 pharmacy Web sites from which GAO obtained samples were found to be under investigation by regulatory agencies for reasons including selling counterfeit drugs and providing prescription drugs where no valid doctor-patient relationship exists. Nine of these were U.S. sites, 1 a Canadian site, and 4 were other foreign Internet pharmacy sites.
GAO-04-888T, Internet Pharmacies: Some Pose Safety Risks for Consumers and Are Unreliable in Their Business Practices
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Testimony:
Before the Permanent Subcommittee on Investigations, Committee on
Governmental Affairs, U.S. Senate:
United States General Accounting Office:
GAO:
For Release on Delivery Expected at 9:00 a.m. EDT:
Thursday, June 17, 2004:
Internet Pharmacies:
Some Pose Safety Risks for Consumers and Are Unreliable in Their
Business Practices:
Statement of Marcia Crosse:
Director, Health Care--Public Health and Military Health Care Issues:
GAO-04-888T:
GAO Highlights:
Highlights of GAO-04-888T, a testimony before the Permanent
Subcommittee on Investigations, Committee on Governmental Affairs, U.S.
Senate
Why GAO Did This Study:
As the demand for and the cost of prescription drugs rise, many
consumers have turned to the Internet to purchase them. However, the
global nature of the Internet can hinder state and federal efforts to
identify and regulate Internet pharmacies to help assure the safety and
efficacy of products sold. Recent reports of unapproved and counterfeit
drugs sold over the Internet have raised further concerns.
This testimony summarizes a GAO report: Internet Pharmacies: Some Pose
Safety Risks for Consumers, GAO-04-820 (June 17, 2004). GAO was asked
to examine (1) the extent to which certain drugs can be purchased over
the Internet without a prescription; (2) whether the drugs are handled
properly, approved by the Food and Drug Administration (FDA), and
authentic; and (3) the extent to which Internet pharmacies are reliable
in their business practices. GAO attempted to purchase up to 10 samples
of 13 different drugs, each from a different pharmacy Web site,
including sites in the United States, Canada, and other foreign
countries. GAO assessed the condition of the samples it received and
forwarded the samples to their manufacturers to determine whether they
were approved by FDA, safe, and authentic. GAO also confirmed the
locations of several Internet pharmacies and undertook measures to
examine the reliability of their business practices.
What GAO Found:
GAO obtained most of the prescription drugs it sought from a variety of
Internet pharmacy Web sites without providing a prescription. GAO
obtained 68 samples of 11 different drugs”each from a different
pharmacy Web site in the United States, Canada, or other foreign
countries, including Argentina, Costa Rica, Fiji, India, Mexico,
Pakistan, Philippines, Spain, Thailand, and Turkey. Five U.S. and all
18 Canadian pharmacy sites from which GAO received samples required a
patient-provided prescription, whereas the remaining 24 U.S. and all 21
foreign pharmacy sites outside of Canada provided a prescription based
on their own medical questionnaire or had no prescription requirement.
Among the drugs GAO obtained without a prescription were those with
special safety restrictions and highly addictive narcotic painkillers.
GAO identified several problems associated with the handling, FDA-
approval status, and authenticity of the 21 samples received from
Internet pharmacies located in foreign countries outside of Canada.
Fewer problems were identified among pharmacies in Canada and the
United States. None of the foreign pharmacies outside of Canada
included dispensing pharmacy labels that provide instructions for use,
few included warning information, and 13 displayed other problems
associated with the handling of the drugs. For example, 3 samples of a
drug that should be shipped in a temperature-controlled environment
arrived in envelopes without insulation. Manufacturer testing revealed
that most of these drug samples were unapproved for the U.S. market
because, for example, the labeling or the facilities in which they were
manufactured had not been approved by FDA; however, manufacturers found
the chemical composition of all but 4 was comparable to the product GAO
ordered. Four samples were determined to be counterfeit products or
otherwise not comparable to the product GAO ordered. Similar to the
samples received from other foreign pharmacies, manufacturers found
most of those from Canada to be unapproved for the U.S. market;
however, manufacturers determined that the chemical composition of all
drug samples obtained from Canada were comparable to the product GAO
ordered.
Some Internet pharmacies were not reliable in their business practices.
Most instances identified involved pharmacies outside of the United
States and Canada. GAO did not receive six orders for which it had
paid. In addition, GAO found questionable entities located at the
return addresses on the packaging of several samples, such as private
residences. Finally, 14 of the 68 pharmacy Web sites from which GAO
obtained samples were found to be under investigation by regulatory
agencies for reasons including selling counterfeit drugs and providing
prescription drugs where no valid doctor-patient relationship exists.
Nine of these were U.S. sites, 1 a Canadian site, and 4 were other
foreign Internet pharmacy sites.
www.gao.gov/cgi-bin/getrpt?GAO-04-888T.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Marcia Crosse at (202) 512-7119.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you discuss the safety of prescription
drugs sold by Internet pharmacies.[Footnote 1] As both the demand for
and the cost of prescription medications have increased, the Internet
has emerged as a growing marketplace for their purchase. Various types
of pharmacies offer prescription drugs over the Internet, including
those that require a patient to provide a physician's prescription and
are sometimes associated with traditional chain drug stores, and other
pharmacies that issue a prescription based on an online medical
questionnaire or have no prescription requirement.
Like traditional pharmacies, Internet pharmacies are subject to state
and federal statutes and regulations designed to ensure the safety and
efficacy of the medications they dispense. However, the global nature
of the Internet poses challenges for regulators. States have identified
Internet pharmacies that do not comply with state pharmacy laws, but
have reported difficulty locating, investigating, and taking action
against the pharmacies when they are located beyond state borders.
Federal agencies have also taken steps to stop illegal Internet sales
of prescription drugs, including by prosecuting Internet pharmacies
that dispense medications without a valid prescription. [Footnote 2]
The Food and Drug Administration (FDA) recently reported instances of
drugs sold over the Internet that were improperly handled, such as
improperly packaged drugs, drugs that were unapproved, and drugs that
were not the authentic products consumers intended to purchase.
Consumer complaints regarding the business practices of some Internet
pharmacies have raised further concerns associated with the use of
Internet pharmacies to obtain prescription drugs.
My testimony will summarize findings of a report we are releasing today
that examines issues surrounding the availability and safety of
prescription drugs sold over the Internet and the business practices of
certain Internet pharmacies.[Footnote 3] In a separate testimony, we
are providing further details about our purchases of narcotics from
Internet pharmacies.[Footnote 4] At your request, Mr. Chairman, we
examined (1) the extent to which certain prescription drugs can be
purchased over the Internet without a prescription; (2) whether drugs
sold by Internet pharmacies are handled properly, are FDA-approved, and
authentic; and (3) the extent to which Internet pharmacies are reliable
in their business practices. We attempted to place up to 10 orders for
each of 13 targeted prescription drugs, each from a different Internet
pharmacy.[Footnote 5] (See table 1.) We generally attempted to purchase
each of the 13 drugs both with and without a prescription, from a range
of Internet pharmacies that purported or appeared to be located in the
United States, Canada, and other foreign countries.[Footnote 6]
Table 1: Prescription Drugs Selected for Purchase From Internet
Pharmacies:
Prescription drug: Accutane®;
Condition treated: Acne;
Remarks: Has special safety restrictions[A].
Prescription drug: Celebrex®;
Condition treated: Arthritis;
Remarks: --.
Prescription drug: Clozaril®;
Condition treated: Schizophrenia;
Remarks: Has special safety restrictions[A].
Prescription drug: Combivir®;
Condition treated: HIV;
Remarks: --.
Prescription drug: Crixivan®;
Condition treated: HIV;
Remarks: --.
Prescription drug: Epogen®;
Condition treated: Anemia;
Remarks: Has special handling requirements.
Prescription drug: Humulin® N;
Condition treated: Diabetes;
Remarks: Has special handling requirements.
Prescription drug: Lipitor®;
Condition treated: High cholesterol;
Remarks: --.
Prescription drug: OxyContin®;
Condition treated: Pain;
Remarks: Schedule II controlled substance, narcotic[B].
Prescription drug: Percocet®;
Condition treated: Pain;
Remarks: Schedule II controlled substance, narcotic[B].
Prescription drug: Viagra®;
Condition treated: Male sexual dysfunction;
Remarks: --.
Prescription drug: Vicodin® /hydrocodone;
Condition treated: Pain;
Remarks: Schedule III controlled substance, narcotic[B].
Prescription drug: Zoloft®;
Condition treated: Depression;
Remarks: - -.
Source: GAO analysis of information from drug manufacturers and the
Drug Enforcement Administration.
[A] Due to health risks associated with using this drug, there are
special safety restrictions imposed on its use and distribution in the
United States, such as a requirement that patients undergo certain
medical tests and restrictions on the distribution of this drug to
physicians with special training or expertise. Because of the health
risks, FDA advises consumers not to purchase this drug over the
Internet.
[B] The Controlled Substances Act established a classification
structure for drugs and chemicals used in the manufacture of drugs that
are designated as controlled substances. Controlled substances are
classified into five schedules on the basis of their medicinal value,
potential for abuse, and safety or dependence liability. Schedule I is
reserved for the most dangerous drugs that have no recognized medicinal
use, while Schedule V is the classification used for the least
dangerous drugs.
[End of table]
We identified whether the samples we received contained a pharmacy
label[Footnote 7] with patient instructions for use and whether
warnings were included on the labels or along with the packaging and
made other observations about the manner in which the drugs were
handled and the condition of the packaging. We forwarded the samples to
the manufacturers of the drugs to determine whether they were FDA-
approved and authentic products, and identify any other safety concerns
associated with the drugs or their handling.[Footnote 8] We also
undertook measures to examine the reliability of Internet pharmacy
business practices, such as attempting to confirm the locations of
certain Internet pharmacies and identifying the pharmacy sites
currently under investigation by federal agencies.
We conducted our work from January through June 2004 in accordance with
generally accepted government auditing standards and in accordance with
the standards of the President's Council on Integrity and Efficiency.
In summary, we were able to obtain the majority of prescription drugs
we targeted for purchase from a wide variety of Internet pharmacies
without providing a prescription. We obtained a total of 68 drug
samples--each from a different pharmacy in the United States, Canada,
or other foreign countries--representing 11 of the 13 drugs we targeted
for purchase. Drug samples received from other foreign pharmacies came
from Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines,
Spain, Thailand, and Turkey. The samples included drugs with special
safety restrictions, and as addressed in our companion statement, we
were also able to obtain addictive narcotic painkillers. Among the
Internet pharmacies from which we obtained drugs, 5 U.S. and all 18
Canadian pharmacies required the patient to provide a prescription,
whereas the remaining 24 U.S. and all 21 other foreign Internet
pharmacies issued prescriptions based on their own medical
questionnaires or had no prescription requirements.
We identified several problems associated with the handling, FDA-
approval status, and authenticity of the 21 drug samples received from
other foreign Internet pharmacies, but fewer problems among the 47
samples received from U.S. and Canadian Internet pharmacies. None of
the 21 samples from other foreign pharmacies included dispensing
pharmacy labels that provided instructions for use, and only about one-
third included warning information. Thirteen of the 21 samples
displayed other problems associated with the handling of the drugs,
such as 3 samples of a temperature-sensitive drug sent in envelopes
without insulation, and 5 samples containing tablets enclosed in
punctured blister packs, potentially exposing the tablets to damaging
light or moisture. Manufacturers reported that most of the drug samples
from other foreign pharmacies (19 of 21 samples) were unapproved for
the U.S. market because, for example, the labeling[Footnote 9] or the
facilities in which they were manufactured had not been approved by
FDA; however, they reported that the chemical composition of all but 4
of the other foreign samples was comparable to the product we had
ordered. Among the 4 exceptions, 2 samples were found to be counterfeit
versions of the product we had ordered, containing a lesser amount of
the active ingredient, and 2 samples had a significantly different
chemical composition than that of the product we had ordered.[Footnote
10] In contrast, all 47 of the drug samples we received from U.S. and
Canadian Internet pharmacies included dispensing pharmacy labels, 41
included warning information, and none displayed evidence of
mishandling. Like the samples from other foreign pharmacies, most of
those from Canada were also unapproved for the U.S. market; however,
manufacturers determined that the chemical composition of all were
comparable to the product we had ordered.
Some Internet pharmacies--mostly other foreign pharmacies--were not
reliable in their business practices. We did not receive six of the
orders we placed and paid for, five of which were placed with other
foreign Internet pharmacies and one of which was placed with a pharmacy
whose location we could not determine. Also, we determined that several
of the drug samples were sent from locations that raise questions, such
as from private residences. We also observed Internet pharmacies that
obscured details about the drugs sold, such as other foreign pharmacies
from which we ordered brand name drugs, but then received a generic or
foreign version of the drug. Finally, about 21 percent of the Internet
pharmacies that sent us samples were found to be under investigation by
the Drug Enforcement Administration (DEA) or FDA. Reasons for the
investigations included allegations of selling adulterated,
misbranded, or counterfeit drugs and providing prescription drugs where
no valid doctor-patient relationship exists. Nine of these pharmacies
were from the United States, one from Canada, and four from other
foreign countries.
Background:
In the United States, the practice of pharmacy is regulated by state
boards of pharmacy, which establish and enforce standards intended to
protect the public. State boards of pharmacy also license pharmacists
and pharmacies. To legally dispense a prescription drug, a licensed
pharmacist working in a licensed pharmacy must be presented a valid
prescription from a licensed health care professional. The requirement
that drugs be prescribed and dispensed by licensed professionals helps
ensure patients receive the proper dose, take the medication correctly,
and are informed about warnings, side effects, and other important
information about the drug.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended, FDA
is responsible for ensuring the safety, effectiveness, and quality of
domestic and imported drugs. To gain approval for the U.S. market, a
drug manufacturer must demonstrate that a drug is safe and effective,
and that the manufacturing methods and controls that will be used in
the specific facility where it will be manufactured meet FDA standards.
The same drug manufactured in another facility not approved by FDA--
such as a foreign-made version of an approved drug--may not be sold
legally in the United States. Drugs are subject to other statutory and
regulatory standards relating to purity, labeling, manufacturing, and
packaging. Failure to meet these standards could result in a drug being
considered illegal for sale in the United States.
The FDCA requires that drugs be dispensed with labels that include the
name of the prescriber, directions for use, and cautionary statements,
among other things. A drug is considered misbranded if its labeling or
container is misleading, or if the label fails to include required
information. Prescription drugs dispensed without a prescription are
also considered misbranded. In addition, if a drug is susceptible to
deterioration and must, for example, be maintained in a temperature-
controlled environment, it must be packaged and labeled in accordance
with regulations and manufacturer standards. Drugs must also be handled
to prevent adulteration, which may occur, for example, if held under
unsanitary conditions leading to possible contamination.
FDA-approved drugs manufactured in foreign countries, including those
sold over the Internet, are subject to the same requirements as
domestic drugs. Further, imported drugs may be denied entry into the
United States if they "appear" to be unapproved, adulterated, or
misbranded, among other things. While the importation of such drugs may
be illegal, FDA has allowed individuals to bring small quantities of
certain drugs into the United States for personal use under certain
circumstances.
Most of the Targeted Prescription Drugs Were Purchased from Multiple
Internet Pharmacies Without Providing A Prescription:
We obtained 1 or more samples of 11 of the 13 drugs we targeted, both
with and without a patient-provided prescription. Drug samples we
received from other foreign pharmacies came from Argentina, Costa Rica,
Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and
Turkey. Most of the drugs--45 of 68--were obtained without a patient-
provided prescription. These included drugs for which physician
supervision is of particular importance due to the possibility of
severe side effects, such as Accutane, or the high potential for abuse
and addiction, such as the narcotic painkiller hydrocodone.[Footnote
11] (See table 2.):
Table 2: Prescription Drugs Ordered and Received from Internet Pharmacies:
Drug ordered: Accutane;
Orders placed[A]: 10;
Drug samples received[B]: 6[C];
Drug samples obtained without a prescription provided by the patient:
3.
Drug ordered: Celebrex;
Orders placed[A]: 10;
Drug samples received[B]: 9;
Drug samples obtained without a prescription provided by the patient:
7.
Drug ordered: Clozaril;
Orders placed[A]: 9;
Drug samples received[B]: 0;
Drug samples obtained without a prescription provided by the patient:
0.
Drug ordered: Combivir;
Orders placed[A]: 6;
Drug samples received[B]: 5;
Drug samples obtained without a prescription provided by the patient:
1.
Drug ordered: Crixivan;
Orders placed[A]: 6;
Drug samples received[B]: 6;
Drug samples obtained without a prescription provided by the patient:
2.
Drug ordered: Epogen;
Orders placed[A]: 1;
Drug samples received[B]: 1;
Drug samples obtained without a prescription provided by the patient:
0.
Drug ordered: Humulin N;
Orders placed[A]: 7;
Drug samples received[B]: 4;
Drug samples obtained without a prescription provided by the patient:
3.
Drug ordered: Lipitor;
Orders placed[A]: 10;
Drug samples received[B]: 9;
Drug samples obtained without a prescription provided by the patient:
6.
Drug ordered: OxyContin;
Orders placed[A]: 1;
Drug samples received[B]: 1;
Drug samples obtained without a prescription provided by the patient:
1.
Drug ordered: Percocet;
Orders placed[A]: 0;
Drug samples received[B]: 0;
Drug samples obtained without a prescription provided by the patient:
0.
Drug ordered: Viagra;
Orders placed[A]: 10;
Drug samples received[B]: 9;
Drug samples obtained without a prescription provided by the patient:
7.
Drug ordered: Vicodin/hydrocodone;
Orders placed[A]: 10;
Drug samples received[B]: 9[C,D];
Drug samples obtained without a prescription provided by the patient:
9.
Drug ordered: Zoloft;
Orders placed[A]: 10;
Drug samples received[B]: 9;
Drug samples obtained without a prescription provided by the patient:
6.
Drug ordered: Total;
Orders placed[A]: 90;
Drug samples received[B]: 68;
Drug samples obtained without a prescription provided by the patient:
45.
Source: GAO.
Note: The samples were shipped by FedEx (24), UPS (3), the U.S. Postal
Service (39), and other couriers (2). Payments were made using Visa and
MasterCard credit cards.
[A] Does not include attempted orders that were not accepted. We did
not reach our goal of placing 10 orders for each drug because we could
not always locate 10 sources from which we could purchase the drugs in
a manner consistent with our methodology's protocols.
[B] We did not receive a drug sample for every order placed. Reasons
included the drug being out of stock, a requirement that physicians
prescribing certain drugs be part of a registry, and pharmacy requests
for follow-up information we could not provide. In several instances,
we could not determine why an order placed was not received.
[C] Includes one sample we could not link to an order we placed.
[D] Although we placed orders for Vicodin, we did not receive any
samples of the brand name version of the drug; all nine samples
received were of the generic equivalent hydrocodone.
[End of table]
Although most of the samples we received were obtained without a
patient-provided prescription, prescription requirements varied. Five
U.S. and all 18 Canadian pharmacies from which we obtained drug
samples required the patient to provide a prescription. The remaining
24 U.S. pharmacies generally provided a prescription based on a general
medical questionnaire filled out online by the patient. Questionnaires
requested information on the patient's physical characteristics,
medical history, and condition for which drugs were being purchased.
Several pharmacy Web sites indicated that a U.S.-licensed physician
reviews the completed questionnaire and issues a prescription. The
other foreign Internet pharmacies we ordered from generally had no
prescription requirements, and many did not seek information regarding
the patient's medical history or condition. The process for obtaining
a drug from many of these pharmacies involved only selecting the
desired medication and submitting the necessary billing and shipping
information. (See table 3.):
Table 3: Prescription Requirements of Pharmacies from which We
Obtained Samples:
Prescription requirement: Prescription from patient's physician must
be provided;
U.S. Internet pharmacies: 5;
Canadian Internet pharmacies: 18;
Other foreign Internet pharmacies: 0.
Prescription requirement: Web site provides prescription based on
questionnaire;
U.S. Internet pharmacies: 24;
Canadian Internet pharmacies: 0;
Other foreign Internet pharmacies: 3.
Prescription requirement: No prescription required;
U.S. Internet pharmacies: 0;
Canadian Internet pharmacies: 0;
Other foreign Internet pharmacies: 18.
Source: GAO.
[End of table]
Most Problems Identified among Drug Samples Received from Other Foreign
Internet Pharmacies:
None of the 21 prescription drug samples we received from other foreign
Internet pharmacies included a dispensing pharmacy label that provided
patient instructions for use, and only 6 of these samples came with
warning information.[Footnote 12] Lack of instructions and warnings on
these drugs leaves consumers who take them at risk for potentially
dangerous drug interactions or side effects from incorrect or
inappropriate use. For example, we received 2 samples purporting to be
Viagra, a drug used to treat male sexual dysfunction, without any
warnings or instructions for use. (See fig. 1.) According to its
manufacturer, this drug should not be prescribed for individuals who
are currently taking certain heart medications, as it can lower blood
pressure to dangerous levels. Additionally, two samples of Roaccutan, a
foreign version of Accutane, arrived without any instructions in
English. (See fig. 2.) Possible side effects of this drug include birth
defects and severe mental disturbances. Compounding the concerns
regarding the lack of warnings and patient instructions for use, none
of the other foreign pharmacies ensured patients were under the care of
a physician by requiring that a prescription be submitted before the
order is filled.
Figure 1: Drug Sample Received Without Any Warnings or Instructions:
[See PDF for image]
Note: Sample purporting to be Viagra® arrived without any warning
information or instructions for use.
[End of figure]
Figure 2: Drug Sample Received Without Any Instructions in English:
[See PDF for image]
Note: Sample of Roaccutan®, a foreign version of Accutane®, arrived
without instructions for use in English.
[End of figure]
We observed other evidence of improper handling among 13 of the 21 drug
samples we received from other foreign Internet pharmacies. For
example, 3 samples of Humulin N were not shipped in accordance with
manufacturer handling specifications. Despite the requirement that this
drug be stored under temperature-controlled and insulated conditions,
the samples we received were shipped in envelopes without insulation.
(See fig. 3.) Similarly, 6 samples of other drugs were shipped in
unconventional packaging, in some instances with the apparent intention
of concealing the actual contents of the package. For example, the
sample purporting to be OxyContin was shipped in a plastic compact disc
case wrapped in brown packing tape--no other labels or instructions
were included, and a sample of Crixivan was shipped inside a sealed
aluminum can enclosed in a box labeled "Gold Dye and Stain Remover
Wax." (See fig. 4.) Additionally, 5 samples we received were damaged
and included tablets that arrived in punctured blister packs,
potentially exposing pills to damaging light or moisture. (See fig. 5.)
One drug manufacturer noted that damaged packaging may also compromise
the validity of drug expiration dates.
Figure 3: Drug Sample Shipped Improperly:
[See PDF for image]
Note: Despite the requirement that Humulin®N be stored under
temperature-controlled and insulated conditions, samples we received
were shipped in an envelope without insulation.
[End of figure]
Figure 4: Drug Samples Shipped in Unconventional Packaging:
[See PDF for image]
Note: Sample purporting to be OxyContin® was shipped in a plastic
compact disc case wrapped in brown packing tape--no other labels or
instructions were included.
Note: Sample of Crixivan® was shipped inside a sealed aluminum can
enclosed in a box labeled "Gold Dye and Stain Remover Wax.":
[End of figure]
Figure 5: Drug Sample Received in Damaged Packaging:
[See PDF for image]
Note: Sample of Crixivan®, a moisture sensitive drug, arrived in
punctured blister packs.
[End of figure]
Among the 21 drug samples from other foreign pharmacies, manufacturers
determined that 19 were not approved for the U.S. market for various
reasons, including that the labeling or the facilities in which they
were manufactured had not been approved by FDA.[Footnote 13] For
example, the manufacturer of one drug noted that 2 samples we received
of that drug were packaged under an alternate name used for the Mexican
market. The manufacturer of another drug found that 3 samples we
received of that drug were manufactured at a facility unapproved to
produce drugs for the U.S. market. In all but 4 instances, however,
manufacturers determined that the chemical composition of the samples
we received from other foreign Internet pharmacies was comparable to
the chemical composition of the drugs we had ordered. Two samples of
one drug were found by the manufacturer to be counterfeit and contained
a different chemical composition than the drug we had ordered. In both
instances the manufacturer reported that samples had less quantity of
the active ingredient, and the safety and efficacy of the samples could
not be determined. Manufacturers also found 2 additional samples to
have a significantly different chemical composition than that of the
product we ordered.
In contrast to the drug samples received from other foreign Internet
pharmacies, all 47 of the prescription drug samples we received from
Canadian and U.S. Internet pharmacies included labels from the
dispensing pharmacy that generally provided patient instructions for
use and 87 percent of these samples (41 of 47) included warning
information. Furthermore, all samples were shipped in accordance with
special handling requirements, where applicable, and arrived undamaged.
Manufacturers reported that 16 of the 18 samples from Canadian Internet
pharmacies were unapproved for sale in the United States, citing for
example unapproved labeling and packaging. However, the samples were
all found to be comparable in chemical composition to the products we
ordered. Finally, the manufacturer found that 1 sample of a moisture-
sensitive medication from a U.S. Internet pharmacy was inappropriately
removed from the sealed manufacturer container and dispensed in a
pharmacy bottle.
Table 4 summarizes the problems we identified among the 68 samples we
received.
Table 4: Problems Observed Among Prescription Drug Samples Received:
Pharmacy location: Canadian;
No warning information (21 samples): Celebrex (2), Zoloft (2);
Not approved for U.S. market (35 samples): Accutane (3), Combivir (3),
Crixivan (3), Humulin N (1), Lipitor (2), Viagra (1), Zoloft (3).
Pharmacy location: Other foreign;
No pharmacy label with instructions for use (23 samples): Accutane (3),
Celebrex (3), Combivir (1), Crixivan (2), Humulin N (3), Lipitor (3),
OxyContin (1), Viagra (2), Zoloft (3);
No warning information (21 samples): Accutane (2), Celebrex (3),
Crixivan (2), Lipitor (3), OxyContin (1), Viagra (2), Zoloft (2);
Improperly shipped or dispensed (4 samples): Humulin N (3);
Unconventional packaging (6 samples): Accutane (1), Celebrex (1),
Crixivan (2), OxyContin (1), Viagra (1);
Damaged packaging (5 samples): Accutane (2), Celebrex (1), Crixivan
(1), Lipitor (1);
Not approved for U.S. market (35 samples): Accutane (2), Celebrex (3),
Combivir (1), Crixivan (1), Humulin N (3), Lipitor (3), OxyContin (1),
Viagra (2), Zoloft (3);
Counterfeit or otherwise not comparable to product ordered (4 samples):
Accutane (1), OxyContin (1), Viagra (2).
Pharmacy location: U.S.;
No pharmacy label with instructions for use (23 samples): Celebrex
(1), Zoloft (1);
No warning information (21 samples): Lipitor (1), Zoloft (1);
Improperly shipped or dispensed (4 samples): Crixivan (1).
Source: GAO and drug manufacturers.
Notes: Drug names indicated are those that GAO ordered. The samples we
received were not the brand name drugs we ordered in all instances.
Drug samples do not add to 68 because some samples exhibited more than
one problem.
[End of table]
Some Internet Pharmacies Were Not Reliable in Their Business Practices:
We observed questionable characteristics and business practices of some
of the Internet pharmacies from which we received drugs. We ultimately
did not receive six of the orders we placed and paid for, suggesting
the potential fraudulent nature of some Internet pharmacies or entities
representing themselves as such.[Footnote 14] The six orders were for
Clozaril, Humulin N, and Vicodin, and cost over $700 in total. Five of
these orders were placed with non-Canadian foreign pharmacies and one
was placed with a pharmacy whose location we could not determine. We
followed up with each pharmacy in late April and early May of 2004 to
determine the status. Three indicated they would reship the product,
but as of June 10, 2004, we had not received the shipments. Three
others did not respond to our inquiry.[Footnote 15]
We determined that at least eight of the return addresses included on
samples we received from other foreign Internet pharmacies were shipped
from locations that raise questions about the entities that provided
the samples. For example, we found a shopping mall in Buenos Aires,
Argentina, at the return address provided on a sample of Lipitor.
Authorities assisting us in locating this address found it impossible
to identify which, if any, of the many retail stores mailed the
package. The return address for a sample of Celebrex was found to be a
business in Cozumel, Mexico, but representatives of that business
informed authorities that it had no connection to an Internet pharmacy
operation. Finally, the return addresses on samples of Humulin N and
Zoloft were found to be private residences in Lahore, Pakistan.
Certain practices of Internet pharmacies may render it difficult for
consumers to know exactly what they are buying. Some non-Canadian
foreign Internet pharmacies appeared to offer U.S. versions of brand
name drugs on their Web sites, but attempted to substitute an
alternative drug during the order process. In some cases, other foreign
pharmacies substituted alternative drugs after the order was placed.
For example, one Internet pharmacy advertised brand name Accutane,
which we ordered. The sample we received was actually a generic version
of the drug made by an overseas manufacturer.
About 21 percent of the Internet pharmacies from which we received
drugs (14 of 68) were under investigation by regulatory agencies. The
reasons for the investigations by DEA and FDA include allegations of
selling controlled substances without a prescription; selling
adulterated, misbranded, or counterfeit drugs; selling prescription
drugs where no doctor-patient relationship exists; smuggling; and mail
fraud. The pharmacies under investigation were concentrated among the
U.S. pharmacies that did not require a patient-provided prescription
(nine) and other foreign (four) pharmacies. One Canadian pharmacy was
also included among those under investigation.
Concluding Observations:
Consumers can readily obtain many prescription drugs over the Internet
without providing a prescription--particularly from certain U.S. and
foreign Internet pharmacies outside of Canada. Drugs available include
those with special safety restrictions, for which patients should be
monitored for side effects, and narcotics, where the potential for
abuse is high. For these types of drugs in particular, a prescription
and physician supervision can help ensure patient safety. In addition
to the lack of prescription requirements, some Internet pharmacies can
pose other safety risks for consumers. Many foreign Internet pharmacies
outside of Canada dispensed drugs without instructions for patient use,
rarely provided warning information, and in four instances provided
drugs that were not the authentic products we ordered. Consumers who
purchase drugs from foreign Internet pharmacies that are outside of the
U.S. regulatory framework may also receive drugs that are unapproved by
FDA and manufactured in facilities that the agency has not inspected.
Other risks consumers may face were highlighted by the other foreign
Internet pharmacies that fraudulently billed us, provided drugs we did
not order, and provided false or questionable return addresses. It is
notable that we identified these numerous problems despite the
relatively small number of drugs we purchased, consistent with problems
recently identified by state and federal regulatory agencies.
Mr. Chairman, this concludes my prepared statement. I would be pleased
to respond to any questions you or other Members of the Subcommittee
may have at this time.
Contacts and Acknowledgments:
For future contacts regarding this testimony, please call Marcia Crosse
at (202) 512-7119. Other individuals who made key contributions include
Randy DiRosa, Margaret Smith, and Corey Houchins-Witt.
FOOTNOTES
[1] Throughout this testimony, each Internet Web site selling
prescription drugs is referred to as an Internet pharmacy.
[2] See U.S. General Accounting Office, Internet Pharmacies: Adding
Disclosure Requirements Would Aid State and Federal Oversight,
GAO-01-69 (Washington, D.C.: Oct. 19, 2000).
[3] U.S. General Accounting Office, Internet Pharmacies: Some Pose
Safety Risks for Consumers, GAO-04-820 (Washington, D.C.: June 17,
2004).
[4] See U.S. General Accounting Office, Internet Pharmacies:
Hydrocodone, An Addictive Narcotic Pain Medication, Is Available
Without a Prescription Through the Internet, GAO-04-892T (Washington,
D.C.: June 17, 2004).
[5] One of the drugs, Humulin N, is prescribed by physicians and is
also available without a prescription. We included it among the drugs
we ordered because of its special handling requirements.
[6] We determined the location of Internet pharmacies from which we
received drug samples based on information contained in the pharmacy
Web sites and the return addresses and postmarks on the packages we
received. Throughout this testimony, Internet pharmacies from countries
other than the United States or Canada are referred to as "other
foreign Internet pharmacies."
[7] The Federal Food, Drug, and Cosmetic Act defines "label" as the
display of written, printed, or graphic matter upon the immediate
container of any article and information required to be on the label
must also be included on the outside container or wrapper, if any, of
the retail package. See 21 U.S.C. § 321(k).
[8] FDA has noted that chemical analysis of prescription drug samples
may not always detect slight changes in the manufacturing process or
different types or amounts of inactive ingredients, which can affect
the comparability and thus therapeutic equivalence of drug samples.
[9] The term "labeling" is broader than the term "label" and includes
all labels and other written, printed, or graphic matter upon an
article or its container or wrapper, or that accompanies the article.
See 21 U.S.C. § 321(m).
[10] Under federal law, counterfeit drugs include those sold under a
product name without proper authorization, which falsely purport or are
represented to be a particular product. See 21 U.S.C. § 321(g)(2).
Counterfeit products may include products without the active
ingredient, with an insufficient quantity of the active ingredient, or
with the wrong active ingredient.
[11] We purchased generic hydrocodone because it was much more readily
available than the brand name drug Vicodin.
[12] One of the samples we received from other foreign pharmacies
included a dispensing pharmacy label; however, this label lacked
patient instructions for use.
[13] The manufacturer of one of the remaining two samples determined it
was approved for the U.S. market and the manufacturer of the other
sample could not make a determination.
[14] The National Association of Boards of Pharmacy has also reported
receiving complaints from consumers who state they have provided
payment to various Internet pharmacies, but have not received the
products ordered.
[15] We received no notice from federal agencies indicating that our
drug samples had been seized, nor did the Internet pharmacies we
contacted about unreceived shipments indicate they had received such
notification.