Internet Pharmacies: Some Pose Safety Risks for Consumers and Are
Unreliable in Their Business Practices (17-JUN-04, GAO-04-888T). 
                                                                 
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.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-04-888T					        
    ACCNO:   A10557						        
  TITLE:     Internet Pharmacies: Some Pose Safety Risks for Consumers
and Are Unreliable in Their Business Practices			 
     DATE:   06/17/2004 
  SUBJECT:   Consumer protection				 
	     Drugs						 
	     Health hazards					 
	     Internet						 
	     Pharmaceutical industry				 
	     Safety regulation					 
	     Safety standards					 
	     Web sites						 

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GAO-04-888T

United States General Accounting Office

GAO Testimony

Before the Permanent Subcommittee on Investigations, Committee on
Governmental Affairs, U.S. Senate

For Release on Delivery

Expected at 9:00 a.m. EDT INTERNET PHARMACIES

Thursday, June 17, 2004

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

Highlights of GAO-04-888T, a testimony before the Permanent Subcommittee
on Investigations, Committee on Governmental Affairs, U.S. Senate

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.

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.

June 17, 2004

INTERNET PHARMACIES

Some Pose Safety Risks for Consumers and Are Unreliable in 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
temperaturecontrolled 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
doctorpatient relationship exists. Nine of these were U.S. sites, 1 a
Canadian site, and 4 were other foreign Internet pharmacy sites.

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.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. 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.3 In a separate testimony, we are providing

1Throughout this testimony, each Internet Web site selling prescription
drugs is referred to as an Internet pharmacy.

2See 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).

3U.S. General Accounting Office, Internet Pharmacies: Some Pose Safety
Risks for Consumers, GAO-04-820 (Washington, D.C.: June 17, 2004).

further details about our purchases of narcotics from Internet
pharmacies.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.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.6

4See 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).

5One 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.

6We 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."

Table 1: Prescription Drugs Selected for Purchase From Internet Pharmacies

Prescription drug Condition treated Remarks

Accutane(R) Acne

Has special safety restrictionsa

Celebrex(R) Arthritis

                       Clozaril(R)    Schizophrenia Has special safety        
                                                    restrictionsa             
                       Combivir(R)              HIV                        -- 
                       Crixivan(R)              HIV                        -- 
                         (R)Epogen           Anemia      Has special handling 
                                                                 requirements 
                     Humulin (R) N         Diabetes      Has special handling 
                                                                 requirements 
                        Lipitor(R) High cholesterol                        -- 
                                               Pain    Schedule II controlled 
                      OxyContin(R)                                 substance, 
                                                                    narcoticb 
                       Percocet(R)                     Schedule II controlled 
                                               Pain                substance, 
                                                                    narcoticb 
                                                      Schedule III controlled 
           Vicodin (R)/hydrocodone             Pain                substance, 
                                                                    narcoticb 
                         Zoloft(R)       Depression                        -- 

Viagra(R) Male sexual dysfunction

Source: GAO analysis of information from drug manufacturers and the Drug
Enforcement Administration.

aDue 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.

bThe 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.

We identified whether the samples we received contained a pharmacy label7
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	

7The 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. S: 321(k).

approved and authentic products, and identify any other safety concerns
associated with the drugs or their handling.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.

8FDA 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.

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 labeling9 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.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.

9The 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.
S: 321(m).

10Under 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. S: 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.

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.11 (See table 2.)

11We purchased generic hydrocodone because it was much more readily
available than the brand name drug Vicodin.

Table 2: Prescription Drugs Ordered and Received from Internet Pharmacies

                                                                 Drug samples 
                                                           obtained without a 
                                                                 prescription 
                                            Drug samples             provided 
                Drug ordered Orders placeda    receivedb       by the patient 
                    Accutane             10           6c 
                    Celebrex             10            9 
                    Clozaril              9            0 
                    Combivir              6            5 
                    Crixivan              6            6 
                      Epogen              1            1 
                   Humulin N              7            4 
                     Lipitor             10            9 
                   OxyContin              1            1 
                    Percocet              0            0 
                      Viagra             10            9 
         Vicodin/hydrocodone             10         9c,d 
                      Zoloft             10            9 
                       Total             90           68 

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.

aDoes 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.

bWe 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.

cIncludes one sample we could not link to an order we placed.

dAlthough 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.

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 U.S. Internet Canadian Internet Other foreign requirement
pharmacies pharmacies Internet pharmacies

                              Prescription from                
                       patient's physician must                
                                    be provided       5                    18 
                              Web site provides                
                          prescription based on                
                                  questionnaire       24                    0 
                       No prescription required       0                     0 

Source: GAO.

  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.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.

12One of the samples we received from other foreign pharmacies included a
dispensing pharmacy label; however, this label lacked patient instructions
for use.

Figure 1: Drug Sample Received Without Any Warnings or Instructions

Source: GAO.

Note: Sample purporting to be Viagra(R) arrived without any warning
information or instructions for use.

Figure 2: Drug Sample Received Without Any Instructions in English

Source: GAO.

Note: Sample of Roaccutan(R), a foreign version of Accutane(R), arrived
without instructions for use in English.

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

Source: GAO.

Note: Despite the requirement that Humulin(R)N be stored under
temperature-controlled and insulated conditions, samples we received were
shipped in an envelope without insulation.

Figure 4: Drug Samples Shipped in Unconventional Packaging

Source: GAO.

Note: Sample purporting to be OxyContin(R) was shipped in a plastic
compact disc case wrapped in brown packing tape-no other labels or
instructions were included.

Source: GAO.

(R)

Note: Sample of Crixivan was shipped inside a sealed aluminum can enclosed
in a box labeled "Gold Dye and Stain Remover Wax."

Figure 5: Drug Sample Received in Damaged Packaging

Source: GAO.

Note: Sample of Crixivan(R), a moisture sensitive drug, arrived in
punctured blister packs.

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.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

13The 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.

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 moisturesensitive 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

                                                                  Counterfeit 
                                                                           or 
                                                                    otherwise 
                No pharmacy                                               not 
                label with        Improperly             Not       comparable 
                                                         approved          to 
                instructions No shipped or       Damaged for U.S.     product 
                        warning Unconventional                    
Pharmacy for use information dispensed      packaging   market     ordered 
                                packaging                         
location    (23 samples) (21 (4 samples) (6 (5        (35      (4 samples) 
                       samples) samples)       samples)  samples) 
Canadian        Celebrex (2)                                   
                     Zoloft (2)                                   
                   Accutane (3) Humulin N (3)                     
    Other          Accutane (2) Accutane (1)                      
foreign         Celebrex (3)   Celebrex (1)                    
                   Celebrex (3)                                   
                   Combivir (1)   Crixivan (2)                    
                   Crixivan (2)                                   
                   Crixivan (2)  OxyContin (1)                    
                    Lipitor (3)                                   
                  Humulin N (3)     Viagra (1)                    
                  OxyContin (1)                                   
             Lipitor (3) Viagra                                   
                            (2)                                   
                  OxyContin (1)                                   
                     Zoloft (2)                                   
                Viagra (2)                                        
                Zoloft (3)                                        

      Accutane (3) Combivir (3) Crixivan (3) Humulin N (1) Lipitor (2) Viagra
                                                               (1) Zoloft (3)

Accutane (2) Accutane (2) Accutane (1) Celebrex (1) Celebrex (3) OxyContin
                                     (1) Crixivan (1) Combivir (1) Viagra (2)

                                                     Lipitor (1) Crixivan (1)
                                                                Humulin N (3)
                                                                  Lipitor (3)
                                                                OxyContin (1)
                                                                   Viagra (2)
                                                                   Zoloft (3)

U.S. Celebrex (1) Lipitor (1) Crixivan (1) Zoloft (1) Zoloft (1)

    Some Internet Pharmacies Were Not Reliable in Their Business Practices

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.

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.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

14The 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.

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.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.

15We 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.

    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 For future contacts regarding this testimony, please call
Marcia Crosse at (202) 512-7119. Other individuals who made key
contributions include Acknowledgments Randy DiRosa, Margaret Smith, and
Corey Houchins-Witt.

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