Internet Pharmacies: Some Pose Safety Risks for Consumers
Published: 2004-06-17T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.
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 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. (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.
We purchased drugs from Internet pharmacies that purported or appeared  to be located in the United States, Canada, and other foreign countries.  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.  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 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 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.  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  and identify any other safety concerns associated with the drugs or their handling.  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.
subsections: section_title: Background
paragraphs: 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. 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 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.  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.
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.
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. 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.
section_title: Most of the Targeted Prescription Drugs Were Purchased from Multiple Internet Pharmacies Without Providing a Prescription
paragraphs: 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.
subsections: section_title: Samples of 11 of 13 Targeted Drugs Obtained from Internet Pharmacies
paragraphs: 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.)
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.)
section_title: The Availability and Ease of Purchase Varied by Drug
paragraphs: 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.  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.   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.
section_title: Most Problems Identified among Drug Samples Received from Other Foreign Internet Pharmacies
paragraphs: 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.
subsections: section_title: All Drug Samples Received from Other Foreign Pharmacies Exhibited Problems Associated with Their Handling
paragraphs: 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.  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.
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.
section_title: Most Drug Samples Received from Other Foreign Pharmacies Were Unapproved, Four Were Not Authentic
paragraphs: 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.  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.
section_title: Drugs Received from Canadian and U.S. Internet Pharmacies Exhibited Fewer Problems
paragraphs: 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.
section_title: Some Internet Pharmacies Were Not Reliable in Their Business Practices
paragraphs: 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.  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.
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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Agency and External Comments
paragraphs: 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.
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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.
section_title: Comments from the Food And Drug Administration
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: 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.
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subsections: section_title: Order by Mail or Phone
section_title: To Report Fraud, Waste, and Abuse in Federal Programs
section_title: Public Affairs