Internet Pharmacies
Some Pose Safety Risks for Consumers Gao ID: GAO-04-820 June 17, 2004As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase drugs. 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. 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 determined whether the samples contained a pharmacy label with patient instructions for use and warnings on the labels or the packaging and forwarded the samples to their manufacturers to determine whether they were approved by FDA and authentic. GAO also confirmed the locations of several Internet pharmacies and identified those under investigation by regulatory agencies.
GAO obtained most of the prescription drugs it targeted 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 required dispensing pharmacy labels that provided 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; 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. In commenting on a draft of this report, FDA generally agreed with its findings and conclusions.
GAO-04-820, Internet Pharmacies: Some Pose Safety Risks for Consumers
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Report to the Chairman, Permanent Subcommittee on Investigations,
Committee on Governmental Affairs, U.S. Senate:
June 2004:
INTERNET PHARMACIES:
Some Pose Safety Risks for Consumers:
GAO-04-820:
GAO Highlights:
Highlights of GAO-04-820, a report to the Chairman, 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 drugs. 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.
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 determined whether the samples
contained a pharmacy label with patient instructions for use and
warnings on the labels or the packaging and forwarded the samples to
their manufacturers to determine whether they were approved by FDA and
authentic. GAO also confirmed the locations of several Internet
pharmacies and identified those under investigation by regulatory
agencies.
What GAO Found:
GAO obtained most of the prescription drugs it targeted 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 required dispensing pharmacy labels that provided 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; 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.
In commenting on a draft of this report, FDA generally agreed with its
findings and conclusions.
www.gao.gov/cgi-bin/getrpt?GAO-04-820.
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 or Robert J. Cramer at (202) 512-7455.
[End of section]
Contents:
Letter:
Results In Brief:
Background:
Most of the Targeted Prescription Drugs Were Purchased from Multiple
Internet Pharmacies Without Providing a Prescription:
Most Problems Identified among Drug Samples Received from Other Foreign
Internet Pharmacies:
Some Internet Pharmacies Were Not Reliable in Their Business Practices:
Concluding Observations:
Agency and External Comments:
Appendixes:
Appendix I: Comments from the Food And Drug Administration:
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Acknowledgments:
Tables:
Table 1: Prescription Drugs Selected for Purchase from Internet
Pharmacies:
Table 2: Prescription Drugs Ordered and Received from Internet
Pharmacies:
Table 3: Prescription Requirements of Pharmacies from which We Obtained
Samples:
Table 4: Problems Observed Among Prescription Drug Samples Received:
Figures:
Figure 1: Drug Sample Received Without Any Warnings or Instructions:
Figure 2: Drug Sample Received Without Any Instructions in English:
Figure 3: Drug Sample Shipped Improperly:
Figure 4: Drug Samples Shipped in Unconventional Packaging:
Figure 5: Drug Sample Received in Damaged Packaging:
Letter June 17, 2004:
The Honorable Norm Coleman:
Chairman:
Permanent Subcommittee on Investigations:
Committee on Governmental Affairs:
United States Senate:
Dear Mr. Chairman:
As both the demand for and the cost of prescription medications have
increased, the Internet has emerged as a growing marketplace for the
purchase of prescription drugs. Internet pharmacies offer benefits for
consumers, such as the convenience of shopping from home 24 hours a day
and the ability to compare prices offered by multiple vendors. Various
types of pharmacies offer prescription drugs over the Internet,
including pharmacies that sell a wide range of drugs, require a patient
to provide a prescription, and are sometimes associated with
traditional chain drug stores, and other pharmacies that issue a
prescription based on an online medical history questionnaire or have
no prescription requirement.[Footnote 1]
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.[Footnote 2] Federal agencies have also taken steps to stop
illegal sales of prescription drugs through Internet pharmacies,
including by prosecuting Internet pharmacies that dispense medications
without a valid prescription. 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.
You asked us to assess:
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.
To determine the extent to which certain prescription drugs can be
purchased over the Internet, we attempted to place up to 10 orders for
each of 13 drugs, each from a different online pharmacy. The 13
targeted drugs included top selling drugs, drugs with special safety
restrictions or handling requirements, drugs that have been
counterfeited in the past, and narcotics.[Footnote 3],[Footnote 4] (See
table 1.) We generally attempted to purchase each of the 13 drugs with
and without a prescription and produced our own prescriptions to enable
us to do so.[Footnote 5]
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.
Prescription drug: Percocet®;
Condition treated: Pain;
Remarks: Schedule II controlled substance, narcotic.
Prescription drug: Viagra®;
Condition treated: Male sexual dysfunction;
Remarks: --.
Prescription drug: Vicodin® /hydrocodone;
Condition treated: Pain;
Remarks: Schedule III controlled substance, narcotic.
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.
[End of table]
We purchased drugs from Internet pharmacies that purported or appeared
to be located in the United States, Canada, and other foreign
countries.[Footnote 6] We purchased drugs from Internet pharmacies with
varying prescription requirements--some required purchasers to provide
a prescription; some required purchasers to fill out an online medical
history questionnaire, based on which a physician affiliated with the
pharmacy issued a prescription; and some had no prescription
requirement. We also purchased drugs from Internet pharmacies that are
licensed online:
providers of prescription drugs.[Footnote 7] To identify the Internet
pharmacies, we relied upon a list of Internet pharmacy Web sites
compiled by a private consultant and provided to us by FDA; used
Internet search engines, including Google, Yahoo, and Excite; and
joined Internet pharmacy members-only Web sites, which provide enrolled
members with lists of Web sites selling various prescription drugs.
Because the universe of Internet pharmacies is not known, and because
we obtained only one drug sample[Footnote 8] from each pharmacy, our
findings cannot be generalized.
To assess whether the drug samples we received were handled properly,
we identified whether the samples contained a pharmacy label[Footnote
9] with patient instructions for use and whether warnings were included
on the labels or along with the packaging. We define handling as the
manner in which Internet pharmacies labeled, packaged, and shipped the
prescription drug samples we received. In addition, we made other
observations about the manner in which the drugs were handled and the
condition of the packaging.[Footnote 10] To assess whether the drug
samples we received were FDA-approved and authentic products, we
forwarded the samples to manufacturers of the drugs that we ordered to
make these determinations[Footnote 11] and identify any other safety
concerns associated with the drugs or their handling.[Footnote 12]
Where manufacturers commented on the adequacy of patient instructions
for use or warnings, we relied upon their assessments rather than our
own judgment. We did not disclose to the manufacturers information
concerning the source of the drug samples we purchased, including
whether the pharmacy purported to be located in the United States,
Canada, or in another foreign country.
To examine the reliability of the business practices of Internet
pharmacies, we contacted Internet pharmacy customer service staff and
several of the processing centers or brokers that handled the
transactions. We also compared the return addresses of some drug
samples received against the business addresses provided by the
processing centers or brokers and listed on the Internet Web sites.
Where the packaging of the drug samples received from foreign Internet
pharmacies raised questions, we coordinated with Drug Enforcement
Administration (DEA) to obtain information about the physical entity
located at the return address on the package and the tenants or owners
of the property. Finally, we obtained information from DEA and FDA
regarding their ongoing investigations of organizations associated with
the Internet pharmacies from which we purchased drugs.
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.
Results In Brief:
We were able to obtain the majority of prescription drugs we targeted
for purchase from a wide variety of domestic and foreign 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.[Footnote 13] 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 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. The
availability and ease with which the drugs could be purchased varied by
drug type. Top selling drugs such as Celebrex, Lipitor, Viagra, and
Zoloft were readily available from multiple Internet pharmacies. Other
drugs, such as those with special safety restrictions--Accutane and
Clozaril--and narcotic painkillers--Percocet, OxyContin, and Vicodin--
were offered for sale by fewer Internet pharmacies or were otherwise
more difficult to obtain.
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 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. For example, 3 samples of a
drug that should be shipped in a temperature-controlled environment
arrived in envelopes without insulation, and 5 samples contained
tablets enclosed in punctured blister packs, potentially exposing the
tablets to damaging light or moisture. Finally, 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 14] 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 15] In contrast, all 47 of the drug samples we
received from U.S. and Canadian Internet pharmacies included dispensing
pharmacy labels that generally provided patient instructions for use,
41 included warning information, and none displayed evidence of
mishandling. Like the samples received 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. Finally, manufacturer
testing identified 1 sample from a U.S. pharmacy that was
inappropriately removed from the sealed manufacturer container and
dispensed in a pharmacy bottle.
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
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.
We provided a draft of this report to FDA, which generally agreed with
our findings and conclusions. We provided a draft of this report to DEA
for a technical review and it informed us it had no comments. We also
provided each manufacturer with segments of this draft report that
related to its product(s). They provided technical comments, which we
incorporated where appropriate.
Background:
Three general types of Internet pharmacies sell prescription drugs
directly to consumers. First, some Internet pharmacies operate much
like traditional drugstores, selling a wide range of prescription drugs
and requiring consumers to submit a prescription from their physicians
before their orders are filled. In some instances, these Internet
pharmacies are affiliated with traditional chain drug stores. Second,
other Internet pharmacies may sell a more limited range of drugs, often
specializing in certain lifestyle medications, such as those that treat
sexual dysfunction or assist in weight control. These Internet
pharmacies typically require consumers to fill out an online medical
history questionnaire in place of a traditional examination by a
physician, and issue a prescription after a physician affiliated with
the pharmacy reviews the questionnaire. Still other Internet pharmacies
dispense drugs without a prescription.
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.[Footnote 16] 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.[Footnote
17] 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 do so, FDA establishes standards for
the safety, effectiveness, and manufacture of drugs that must be met
before they are approved for the U.S. market. To gain approval, 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.[Footnote 18] Failure to meet these standards could result in
a drug being considered adulterated or misbranded and therefore illegal
for sale, which could result in FDA enforcement action.[Footnote 19]
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.[Footnote 20] 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.[Footnote 21]
Internet pharmacies pose challenges for regulators. State boards of
pharmacy in many states have reported difficulty identifying Internet
pharmacies located outside of their borders and have limited ability
and authority to investigate and act against pharmacies that do not
comply with state pharmacy laws when they are identified. In 2000,
nearly half of the state boards had identified consumer complaints
against Internet pharmacies or reported problems with Internet
pharmacies not complying with state pharmacy laws. Additionally, state
medical boards have reported receiving complaints about physicians
prescribing drugs over the Internet without performing an examination
of the patient.[Footnote 22] Federal agencies have taken steps to stop
the illegal sales of prescription drugs and other substances by
Internet pharmacies. For example, FDA has taken enforcement actions
against Internet pharmacies; the Department of Justice has prosecuted
Internet pharmacies and physicians for dispensing medications without a
valid prescription; and DEA has investigated Internet pharmacies for
illegal distribution of controlled substances.
Most of the Targeted Prescription Drugs Were Purchased from Multiple
Internet Pharmacies Without Providing a Prescription:
We were able to obtain the majority of prescription drugs we targeted
for purchase from a wide variety of domestic and foreign Internet
pharmacies without providing a prescription. Five U.S. and all 18
Canadian pharmacies from which we obtained drug samples required a
patient-provided prescription, whereas the remaining 24 U.S. and all 21
other foreign pharmacies from which we obtained samples either provided
a prescription based on an online medical questionnaire or had no
prescription requirement. Although we obtained samples of most of the
drugs we targeted for purchase, some drugs, such as those with special
safety restrictions and narcotics, were available from fewer sources or
were more difficult to obtain.
Samples of 11 of 13 Targeted Drugs Obtained from Internet Pharmacies:
We obtained 1 or more samples of 11 of the 13 drugs we targeted, both
with and without a patient-provided prescription. In total, we placed
90 orders--each with a different Internet pharmacy in the United
States, Canada, and other foreign countries--and received 68 samples.
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. (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).
[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]
The Availability and Ease of Purchase Varied by Drug:
While we obtained samples of most of the drugs we targeted for purchase
on the Internet, certain drugs were more widely available and easier to
purchase than others. The top selling drugs Celebrex (a pain reliever),
Lipitor (a cholesterol-lowering drug), Viagra (a medication for male
sexual dysfunction), and Zoloft (an antidepressant) were available from
multiple pharmacies. We placed 10 orders for each of these four drugs
with little difficulty.
Other drugs were available from fewer sources or were more difficult to
obtain. Some of our orders for drugs with special safety restrictions
were more closely scrutinized. For example, one order we placed for
Accutane was declined by a U.S. pharmacy. Accutane is an acne
medication that may cause birth defects and serious mental disturbances
leading to suicide among some users. The pharmacy indicated that it
declined our order because the physician was not included on a national
registry of qualified prescribers.[Footnote 23] Similarly, one U.S. and
one Canadian Internet pharmacy declined our order for Clozaril.
According to its manufacturer, patients taking Clozaril, an
antipsychotic medication, must have ongoing blood tests to monitor for
the development of a fatal blood disorder that can occur during
treatment. The U.S. pharmacy that declined our order indicated that
Clozaril should not have been offered for sale on its Web site, and the
Canadian pharmacy indicated that more stringent prescription
requirements prevented it from dispensing the drug to patients outside
of Canada.
Narcotic pain medications--OxyContin, Percocet, and Vicodin--were also
less readily available. Despite extensive searching of Internet
pharmacy sites, we found few that sold these drugs without a
prescription. Other factors also hindered our ability to purchase these
drugs. For example, some pharmacies that advertised the narcotics did
not actually sell them. Rather, they attempted to substitute a
different, often less potent and nonnarcotic drug once the order was
placed. In addition, several pharmacies that offered narcotics required
payment by means that were beyond our scope, such as check, bank
transfers, or "e-gold" exchanges.[Footnote 24] We were able to place
orders for the generic version of Vicodin at several U.S. pharmacies;
however, some of these pharmacies required not only an online medical
questionnaire, but also a telephone consultation with a pharmacy-
designated physician in order to obtain a prescription. Finally, we
were able to place only one order for a drug purporting to be
OxyContin, and only after locating the source by paying a membership
fee and joining an Internet pharmacy drug club, which referred us to
the site.
Most Problems Identified among Drug Samples Received from Other Foreign
Internet Pharmacies:
We identified several problems associated with the handling, FDA-
approval status, and authenticity of the 21 drug samples we received
from other foreign Internet pharmacies. None included required pharmacy
labels that provided patient instructions for use, and few provided
warning information. Thirteen were shipped improperly, were packaged
unconventionally, or arrived damaged. Manufacturers reported that most
of the samples they reviewed at our request from other foreign
pharmacies were not approved by FDA for the United States--although
most had a comparable chemical composition to the product we ordered--
and 4 were either counterfeit products or otherwise not comparable to
the product we ordered. While most of the samples received from
Canadian Internet pharmacies were unapproved for the U.S. market, they
otherwise had a comparable chemical composition, and the samples from
U.S. and Canadian pharmacies exhibited few problems otherwise. 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]
All Drug Samples Received from Other Foreign Pharmacies Exhibited
Problems Associated with Their Handling:
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 the samples came with
warning information.[Footnote 25] 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, 2 samples of Roaccutan, a
foreign version of Accutane, arrived without any instructions in
English. (See fig. 2.) As noted, 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, three 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]
Most Drug Samples Received from Other Foreign Pharmacies Were
Unapproved, Four Were Not Authentic:
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 26] 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 had ordered.
Drugs Received from Canadian and U.S. Internet Pharmacies Exhibited
Fewer Problems:
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. pharmacy was inappropriately removed from the sealed
manufacturer container and dispensed in a pharmacy bottle.
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. Most, but not
all, involved other foreign pharmacies. These included pharmacies that
accepted payment but did not provide the drugs ordered, shipments of
drugs with questionable return addresses, pharmacies that obscured
details about the drugs sold, and pharmacies that were under
investigation by regulatory agencies.
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 27] 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 28]
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
(9) and other foreign (4) 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 for which patients should be monitored for side effects or 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.
Agency and External Comments:
In commenting on a draft of this report, FDA generally agreed with our
findings and conclusions and made suggestions to clarify or expand upon
its contents (see app. II). FDA commented that, while the draft report
noted Internet pharmacy Web sites purported or appeared to be from
various countries, the draft did not demonstrate that the drug samples
we received were actually sent from those countries, such as by
discussing return addresses and postmarks on the samples. FDA suggested
we indicate the methods we used to determine the samples' origins. We
modified the report to indicate that we determined the location of the
Internet pharmacy Web sites 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. FDA also commented
that our finding that certain unapproved drugs were chemically
equivalent to the brand name products we ordered was misleading. FDA
noted that chemical equivalence testing may not always determine
whether a drug is comparable in all respects to the FDA-approved drug
and therefore fully therapeutically equivalent. We relied on
manufacturers to determine whether the drug samples we received were
comparable to their own FDA-approved brand name version of the drug,
and manufacturers conducted a range of tests to make this
determination. Nevertheless we modified the final report to note the
potential limitations to chemical equivalence testing. FDA also made
several observations about the practices of Internet pharmacies and
provided technical comments, which we incorporated where appropriate.
We also provided a draft of this report to DEA for technical comments
and to ensure information we reported did not compromise its ongoing
investigations. The agency responded that it had no comments.
Finally, we provided segments of the draft report to the manufacturer
of each drug sample we received. Each manufacturer reviewed the
segments of the draft report relating to its own product(s), and
provided technical comments, which we incorporated as appropriate.
As agreed with your office, unless you publicly announce this report's
contents, we plan no further distribution until 30 days after its issue
date. At that time, we will send copies to the Acting Commissioner of
FDA, the Administrator of DEA, and others upon request. In addition,
this report will be available at no charge at the GAO Web site at
[Hyperlink, http://www.gao.gov].
Please call Marcia Crosse at (202) 512-7119 or Robert Cramer at (202)
512-7455 if you have any questions. Another contact and other major
contributors are listed in appendix I.
Sincerely yours,
Signed by:
Marcia Crosse:
Director, Health Care--Public Health and Military Health Care Issues:
Signed by:
Robert J. Cramer:
Managing Director, Office of Special Investigations:
[End of section]
Appendixes:
Appendix I: Comments from the Food And Drug Administration:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Food and Drug Administration
Rockville MD 20857:
June 4, 2004:
Marcia Crosse:
Director, Health Care-Public Health and Military Health Care Issues:
United States General Accounting Office:
441 G Street, N.W.
Washington, D.C. 20548:
Dear Ms. Crosse:
Please find the enclosed comments from the Food and Drug Administration
on the GAO draft report entitled INTERNET PHARMACIES: Some Pose Safety
Risks for Consumers (GAO-04-820). The Agency provided technical
comments directly to your staff.
We appreciate the opportunity to review and comment on this draft
report before its publication as well as the opportunity to work with
your staff in finalizing this report.
Sincerely,
Signed by:
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs:
Enclosure:
General Comments by the Department of Health and Human Services' Food
and Drug Administration on GAO's Draft Report, INTERNET PHARMACIES:
Some Pose Safety Risks for Consumers (GAO-04-820):
The FDA appreciates the opportunity to review and comment on GAO's
draft report. FDA concurs with the overall conclusions contained in
this report that many imported prescription drugs appear to be of poor
quality, are mishandled, have questionable authenticity and approval
status, and that these drugs are readily available and can be easily
purchased by consumers via Internet pharmacies. Our general comments
follow:
1. The report repeatedly states that the Internet sites "purported" or
"appeared" to be from Canada, the U.S., or other foreign countries. The
study does not demonstrate with any certainty, particularly for the
U.S. or Canadian websites, that the products were sent from or
manufactured for use in those countries. It also does not discuss
return address labels, post marks or other indicators of the origin of
the packages. If Congress were to legalize importation of prescription
drugs, we anticipate a proliferation of websites claiming to be
Canadian pharmacies and entry of unscrupulous individuals into the
marketplace. It is easy to design a fraudulent Canadian website that
looks completely legitimate. We request that GAO make clear in its
report how they determined the origin of the products they purchased.
Further, when GAO refers to a "Canadian Internet pharmacy," how is that
defined? Even if Canadian drugs are absolutely reliable, American
consumers would still need a way to make sure that the medicines they
order are actually coming from Canada and not simply transshipped
through the country.
2. Many Canadian Internet Pharmacies market specifically to U.S.
citizens seeking lower drug prices. The numerous storefront Canadian
pharmacy operations in the U.S. are a direct offshoot of these business
initiatives.
3. In several places throughout the report, GAO comments that, while
"unapproved", the drugs obtained from abroad were chemically equivalent
to FDA-approved drugs. We think this claim is misleading. Whether a
foreign product contains the same active ingredient is no guarantee
that it is identical to the FDA-approved product. For example, the
foreign drug may contain different inactive ingredients (to which some
persons may be allergic), and there is no guarantee that the foreign
and FDA-approved drugs are bioequivalent.
Because two drug products are "chemically equivalent" does not make
them therapeutically equivalent. Most of a generic drug's application
review is directed to demonstrating its bioequivalence to the innovator
drug.
Drug products are considered to be therapeutic equivalent only if they
are pharmaceutical equivalents and if they can be expected to have the
same clinical effect and safety profile when administered to patients
under the conditions specified in the labeling.
4. The report does not mention the fact that criminal enforcement of the
FD&C Act as it relates to the "online questionnaire" used in most
domestic sites selling non-controlled prescription pharmaceuticals
depends on individual States interpretation of what constitutes a valid
prescription. This, in turn depends on their interpretation of what
constitutes an adequate "doctor/patient relationship". Some states do
not require a "face to face" medical evaluation. Where this is the
case, FDA is deprived of the "misbranding" charge that results from the
allegation that a prescription based solely on review of an online
questionnaire is not valid.
5. Many U.S. Internet pharmacy sites selling drugs through the use of an
online questionnaire do not offer lower prices, but cater to persons
seeking so called "lifestyle" drugs, or to others wanting to avoid a
doctor's visit or those intent on self-prescribing. These sites sell
such drugs as Viagra, Zenical, Propecia and minor tranquilizers usually
at a higher price than in a traditional brick and mortar or Internet
pharmacy.
6. Sites that sell controlled substances do so usually at substantial
mark up. For example, the AWP for generic Percocet is $11 but it sells
for $265 per hundred on the Internet. These Internet sites are often
sought out by drug abusers. Sites that are identified in the report as
operating legally, like traditional drug stores, do not sell controlled
substances because of DEA restrictions. FDA has found an increased
number of controlled substances in the two "port blitzes" it did in
2003. In 2004 the large volume of controlled substances coming into the
U.S. continues.
7. The sampling GAO conducted is extremely small when viewed in the
context of the vast number of Internet sites offering prescription
drugs for sale. Although the size of the study demonstrates the gravity
of the situation regarding "other foreign" Internet sites, a much
larger study that has statistical significance should be considered.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Randy M. DiRosa, (312) 220-7671:
Acknowledgments:
Major contributors to this report were Margaret Smith, Corey Houchins-
Witt, Andrew O'Connell, Ramon Rodriguez, Julian Klazkin, Helen
Desaulniers, Robert Copeland, and Harold Lewis.
(290339):
FOOTNOTES
[1] Throughout this report, we refer to each Internet Web site selling
prescription drugs 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] 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.
[4] 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. We attempted to purchase Schedule II and Schedule III
narcotics. See 21 U.S.C. §§ 811 and 812.
[5] Due to the heightened regulation of controlled substances, we did
not attempt to purchase narcotics from pharmacies that required
patients to submit a prescription from their physicians.
[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 report, we refer to Internet pharmacies from
countries other than the United States or Canada as "other foreign
Internet pharmacies."
[7] We selected these Internet pharmacies from among those associated
with large drugstore chains and those certified as Verified Internet
Pharmacy Practice Sites (VIPPS) by the National Association of Boards
of Pharmacy (NABP). VIPPS certification is voluntary and indicates that
the pharmacy meets applicable state licensure requirements and certain
other criteria established by NABP.
[8] This report uses the word "samples" to refer to our purchases of
drugs from Internet pharmacies rather than to those drugs provided to
practitioners and others for the purpose of promoting drug sales. See
21 U.S.C. § 353(c)(1)(2000).
[9] 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).
[10] We did not conduct a comprehensive review of the pharmacies'
compliance with all applicable federal and state laws and regulations.
[11] 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.
[12] We sent samples of the generic drug hydrocodone to the
manufacturer of Vicodin for testing.
[13] We did not obtain samples of 2 of the 13 drugs we targeted for
purchase. We placed nine orders for one of the drugs but received none,
and we identified no source from which to purchase the other drug in a
manner consistent with our methodology's protocols.
[14] 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).
[15] 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.
[16] Most states also license out-of-state pharmacies that dispense
drugs to state residents, and some states regulate Internet pharmacies
in a similar manner. See GAO-01-69.
[17] States also license health care professionals, grant them
prescribing privileges, and outline standards of practice in state
medical practice laws.
[18] See, e.g., 21 U.S.C. §§ 351(b), 352(g), 352(h), 352(p), 355(d); 21
C.F.R. pts. 201 and 210 (2003). Additional requirements apply to
controlled substances under the Controlled Substances Act and DEA's
implementing regulations.
[19] Other federal agencies also play a role with respect to the
regulation of prescription drugs under various circumstances. See GAO-
01-69. GAO is currently reviewing available data on the volume of
prescription drugs entering the United States through the Postal
Service and private couriers and the policies and practices of federal
agencies charged with preventing unapproved prescription drugs from
entering the country.
[20] The recently enacted Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 directed the Secretary of Health and Human
Services to create a system for the importation of prescription drugs
from Canada upon certification that the implementation of the program
would (1) pose no additional risk to the public's health and safety and
(2) result in a significant reduction in the cost of covered products
to the American consumer. The act directed the Secretary to complete a
study on drug importation from Canada within 1 year of enactment. See
Pub. L. No. 108-173, §§ 1121, 1122, 117 Stat. 2066, 2464-69 (to be
codified at 21 U.S.C. §§ 384, 384 note).
[21] FDA guidelines indicate that agency officials may use their
discretion to allow importation if (1) the intended use is identified,
is not for a serious condition, and the product is not known to
represent a significant health risk; or (2) if the intended use is
unapproved and for a serious condition for which effective treatment
may not be available domestically, and other conditions are also met.
See Chapter 9 of FDA's Regulatory Procedures Manual. http://
www.fda.gov/ora/compliance_ref/rpm/default.htm. Downloaded June 10,
2004.
[22] In 2000, 39 of 45 state medical boards responding to our survey
indicated that a physician who issued a prescription on the basis of an
online questionnaire would not satisfy the standard of good medical
practice required under their states' laws. SeeGAO-01-69.
[23] Risk management protocols developed by the manufacturer in
agreement with FDA prohibit U.S. pharmacies from accepting electronic
prescriptions for this drug.
[24] "e-gold" is a system where sellers and buyers can establish
accounts and electronically exchange values or amounts of gold in order
to complete Internet transactions.
[25] One of the samples we received from other foreign pharmacies
included a dispensing pharmacy label; however, this label lacked
patient instructions for use.
[26] 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.
[27] NABP has reported receiving complaints from consumers who state
they have provided payment to various Internet pharmacies, but have not
received the products ordered.
[28] 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.
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