This is the accessible text file for GAO report number GAO-04-888T 
entitled 'Internet Pharmacies: Some Pose Safety Risks for Consumers and 
Are Unreliable in Their Business Practices' which was released on June 
17, 2004.

This text file was formatted by the U.S. General Accounting Office 
(GAO) to be accessible to users with visual impairments, as part of a 
longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov.

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately.

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.