Prescription Drugs: Strategic Framework Would Promote Accountability and Enhance Efforts to Enforce the Prohibitions on Personal Importation
Published: 2005-09-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Consumers can be violating the law and possibly risking their health by purchasing imported prescription drugs over the Internet. U.S. Customs and Border Protection (CBP), in the Department of Homeland Security (DHS), and the Food and Drug Administration (FDA), in the Department of Health and Human Services (HHS), work with other federal agencies at international mail and express carrier facilities to inspect for and interdict prescription drugs illegally imported for personal use. This report addresses (1) available data about the volume and safety of personal prescription drug imports, (2) the procedures and practices used to inspect and interdict prescription drugs unapproved for import, (3) factors affecting federal efforts to enforce the laws governing prescription drugs imported for personal use, and (4) efforts federal agencies have taken to coordinate enforcement efforts.
section_title: What GAO Found
paragraphs: The information currently available on the safety of illegally imported prescription drugs is very limited, and neither CBP nor FDA systematically collects data on the volume of these imports. Nevertheless, on the basis of their own observations and limited information they collected at some mail and carrier facilities, both CBP and FDA officials said that the volume of prescription drugs imported into the United States is substantial and increasing. FDA officials said that they cannot assure the public of the safety of drugs purchased from foreign sources outside the U.S. regulatory system. FDA has issued new procedures to standardize practices for selecting packages for inspection and making admissibility determinations. While these procedures may encourage uniform practices across mail facilities, packages containing prescription drugs continue to be released to the addressees. CBP has also implemented new procedures to interdict and destroy certain imported controlled substances, such as Valium. CBP officials said the new process is designed to improve their ability to quickly handle packages containing these drugs, but they did not know if the policy had affected overall volume because packages may not always be detected. We identified three factors that have complicated federal enforcement of laws prohibiting the personal importation of prescription drugs. First, volume has strained limited federal resources at the mail facilities. Second, Internet pharmacies can operate outside the U.S. regulatory system and evade federal law enforcement actions. Third, current law requires FDA to give addressees of packages containing unapproved imported drugs notice and the opportunity to provide evidence of admissibility regarding their imported items. FDA and HHS have testified before Congress that this process placed a burden on limited resources. In May 2001, FDA proposed to the HHS Secretary that this legal requirement be eliminated, but according to FDA and HHS officials, as of July 2005, the Secretary had not responded with a proposal. FDA officials stated that any legislative change might require consideration of such issues as whether to forgo an individual's opportunity to provide evidence of the admissibility of the drug ordered. Prior federal task forces and working groups had taken steps to deal with Internet sales of prescription drugs since 1999, but these efforts did not position federal agencies to successfully address the influx of these drugs imported from foreign sources. Recently, CBP has organized a task force to coordinate federal agencies' activities to enforce the laws prohibiting the personal importation of prescription drugs. The task force's efforts appear to be steps in the right direction, but they could be enhanced by establishing a strategic framework to define the scope of the problem at mail and carrier facilities, determine resource needs, establish performance measures, and evaluate progress. Absent this framework, it will be difficult to oversee task force efforts; hold agencies accountable; and ensure ongoing, focused attention to the enforcement of the relevant laws.

section_title: Letter
paragraphs: The first Internet pharmacies began online service in early 1999. Since that  time, American consumers have been increasingly drawn to the  convenience, privacy, and cost advantages that might be accrued by  purchasing prescription drugs over the Internet. Individual consumers can  order over the Internet a range of prescription drugs from controlled  substances, such as Valium, to noncontrolled prescription drugs intended  to improve an individual’s quality of life by addressing non-life-threatening  conditions such as baldness, impotence, and obesity. Internet pharmacies,  particularly those pharmacies located in foreign countries, can operate  outside the U.S. regulatory process, which requires a licensed pharmacist  to dispense a prescription drug when presented with a valid prescription  from a licensed health care professional. According to FDA, there are  legitimate Internet pharmacies that comply with applicable federal and  state laws. However, the broad reach and access of the Internet allows the  easy creation of online pharmacies that can anonymously traverse state  and national borders to prescribe, sell, and dispense prescription drugs  without complying with traditional state or federal regulatory safeguards.
Under current law, the importation of prescription drugs, both controlled  and noncontrolled, for personal use is illegal, with few exceptions.  However, in recent years, Congress and others have debated whether  Americans should be allowed to purchase drugs from pharmacies located  in foreign countries. Members of Congress have introduced various bills  related to this issue. Proponents argue that American consumers should  be allowed to import prescription drugs because drugs purchased from  some foreign pharmacies are viewed as safe and more affordable.  Opponents contend that drugs from unregulated sources are not proven to  be safe and effective and could be harmful. In addition, some allege that  packages of prescription drugs purchased on the Internet and imported for  personal use could be bundled together and sold to others. Currently,  consumers could be violating federal law, unknowingly or intentionally, by  having drugs shipped, in effect, imported, into the United States through  the international mail and private carriers. Two acts specifically regulate  the importation of prescription drugs into the United States. That is, all  prescription drugs offered for import must meet the requirements of the  Federal Food, Drug, and Cosmetic Act, and those that are controlled  substances also must meet the requirements of the Controlled Substances  Import and Export Act. Prescription drugs imported for personal use  generally do not meet these requirements.
Several federal agencies have responsibility for regulating the importation  of prescription drugs through the international mail and private carriers.  They include the Department of Homeland Security’s (DHS) U.S. Customs  and Border Protection (CBP), which can inspect international mail and  packages for potentially illegal drugs entering the United States through  the U.S. Postal Service’s (USPS) international mail facilities or private  carriers; the Department of Health and Human Services’ (HHS) Food and  Drug Administration (FDA), which is responsible for ensuring the safety,  effectiveness, and quality of domestic and imported drugs; the Department  of Justice’s Drug Enforcement Administration (DEA), which regulates  controlled substances; and the Department of Homeland Security’s U.S.  Immigration and Customs Enforcement (ICE), which has law enforcement  responsibilities that include investigations of prescription drugs coming  into the United States through the mail and express carriers. Also, the  Office of National Drug Control Policy (ONDCP) formulates the nation’s  drug control strategy and addresses policy issues concerning the illegal  distribution of controlled substances, as its authority does not extend over  noncontrolled substances.
You expressed interest in learning how federal agencies are addressing the  importation of prohibited prescription drugs through international mail  and carrier facilities. In this report, we address the following questions:   (1) What do the available data show about the volume and safety of  prescription drugs imported into the United States for personal use  through the international mail and private carriers? (2) What procedures  and practices are used at selected facilities to inspect and interdict  prescription drugs unapproved for import? (3) What factors affect federal  agency efforts to enforce the prohibition on prescription drug importation  for personal use through international mail and carrier facilities? (4) What  efforts have federal agencies undertaken to coordinate the enforcement of  the prohibitions on personal importation of prescription drugs?
To answer these questions, we reviewed current federal laws, available  studies and reports on the importation of prescription drugs and  controlled substances, CBP and FDA procedures and practices related to  prescription drugs and controlled substance importation, and applicable  importation volume and safety data. We conducted interviews with  officials from CBP, FDA, DEA, USPS, ONDCP, and ICE, as well as  representatives of MasterCard International and Visa U.S.A., Inc. We  visited five facilities: three international mail facilities located in  California, Illinois, and New York and two carrier facilities located in Ohio  (for the DHL Corporation) and Tennessee (for the FedEx Corporation).  We selected these facilities to include those with a high volume of  processed packages and wide geographic dispersion. At these locations,  we observed inspection and interdiction practices; met with CBP and FDA  management, inspectors, and investigators; and reviewed relevant  documents on inspection and interdiction procedures. At the international  mail facilities, we also met with officials from USPS regarding mail  handling and processing procedures. The information from our site visits  is limited to the 3 international mail facilities and 2 carrier facilities and is  not generalizable to all 14 international mail facilities and 29 carrier  facilities. We conducted our review from April 2004 to August 2005 in  accordance with generally accepted government auditing standards.  Appendix I provides more details about our scope and methodology.
subsections: section_title: Background
paragraphs: All international mail and packages entering the United States through the  U.S. Postal Service and private carriers are subject to potential CBP  inspection at the 14 USPS international mail facilities and 29 express  consignment carrier facilities operated by private carriers located around  the country. CBP inspectors can target certain packages for inspection or  randomly select packages for inspection. CBP inspects for, among other  things, illegally imported controlled substances, contraband, and items— like personal shipments of noncontrolled prescription drugs—that may be  inadmissible. CBP inspections can include examining the outer envelope  of the package, using X-ray detectors, or opening the package to physically  inspect the contents. Each year the international mail and carrier facilities  process hundreds of millions of pieces of mail and packages. Among these  items are prescription drugs ordered by consumers over the Internet, the  importation of which is prohibited under current law, with few exceptions.
Two acts—the Federal Food, Drug, and Cosmetic Act and the Controlled  Substances Import and Export Act—specifically regulate the importation  of prescription drugs into the United States. Under the Federal Food,  Drug, and Cosmetic Act, as amended, FDA is responsible for ensuring the  safety, effectiveness, and quality of domestic and imported drugs and may  refuse to admit into the United States any drug that appears to be  adulterated, misbranded, or unapproved for the U.S. market as defined in  the act. Under the act and implementing regulations, this includes foreign  versions of FDA-approved drugs if, for example, neither the foreign  manufacturing facility nor the manufacturing methods and controls were  reviewed by FDA for compliance with U.S. statutory and regulatory  standards. The act also prohibits reimportation of a prescription drug  manufactured in the United States by anyone other than the original  manufacturer of that drug. According to FDA, prescription drugs imported  by individual consumers typically fall into one of these prohibited  categories. However, FDA has established a policy that allows local FDA  officials to use their discretion to not interdict personal prescription drug  imports that do not contain controlled substances under specified  circumstances, such as importing a small quantity for treatment of a  serious condition, generally not more than a 90-day supply of a drug not  available domestically. The importation of prohibited foreign versions of  prescription drugs like Viagra (an erectile dysfunction drug) or Propecia (a  hair loss drug), for example, would not qualify under the personal  importation policy because approved versions are readily available in the  United States.
In addition, the Controlled Substances Import and Export Act, among  other things, generally prohibits personal importation of those  prescription drugs that are controlled substances, such as Valium. (See  app. II for a general description of controlled substances.) Under the act,  shipment of controlled substances to a purchaser in the United States  from another country is only permitted if the purchaser is registered with  DEA as an importer and is in compliance with the Controlled Substances  Import and Export Act and DEA requirements. As outlined in the act, it  would be difficult, if not impossible, for an individual consumer seeking to  import a controlled substance for personal use to meet the standards for  registration and related requirements. Figure 1 illustrates the two acts that  specifically govern the importation of prescription drugs into the United  States. It also presents the roles of FDA, DEA, and CBP in implementing  those acts.
CBP is to seize illegally imported controlled substances it detects on  behalf of DEA. CBP may take steps to destroy the seized and forfeited  substance or turn the seized substance over to other federal law  enforcement agencies for further investigation. CBP is to turn over  packages suspected of containing prescription drugs that are not  controlled substances to FDA. FDA investigators may inspect such  packages and hold those that appear to be adulterated, misbranded, or  unapproved, but must notify the addressee and allow that individual the  opportunity to present evidence as to why the drug should be admitted  into the United States. If the addressee does not provide evidence that  overcomes the appearance of inadmissibility, then the item is refused  admission and returned to the sender.
Investigations that may arise from CBP and FDA inspections may fall  within the jurisdiction of other federal agencies. DEA, ICE, and FDA  investigators have related law enforcement responsibilities and may  engage in investigations stemming from the discovery of illegally imported  prescription drugs. Although USPS’s Inspection Service does not have the  authority, without a federal search warrant, to open packages suspected of  containing illegal drugs, it may collaborate with other federal agencies in  certain investigations. Also, ONDCP is responsible for formulating the  nation’s drug control strategy and has general authority for addressing  policy issues concerning the illegal distribution of controlled substances.  ONDCP’s authority does not, however, include prescription drugs that are  not controlled substances.
section_title: Volume of Prescription Drug Imports Is Unknown but Believed to Be Substantial, and the Safety of These Drug Imports Is Not Assured
paragraphs: CBP and FDA do not systematically collect data on the volume of  prescription drugs and controlled substances they encounter at the mail  and carrier facilities. On the basis of their own observations and limited  information they obtained at selected mail and carrier facilities, CBP and  FDA officials believe the volume of prescription drug importation into the  United States is substantial and increasing. However, neither agency has  developed reliable estimates of the number of prescription drugs imported  into the country. Further, the available information shows that some  imported prescription drugs can pose safety concerns. We reported in  June 2004 that prescription drugs purchased from some foreign-based  Internet pharmacies posed safety risks for consumers. FDA officials said  that they cannot assure the public of the safety and quality of drugs  purchased from foreign sources that are largely outside the U.S. regulatory  system. Of particular concern is the access to highly addictive controlled  substances, which can be imported by consumers of any age sometimes  without a prescription or consultation with a physician.
subsections: section_title: CBP and FDA Do Not Know the Full Scope of Prohibited Prescription Drug Importation, but Believe It to Be Substantial
paragraphs: CBP and FDA do not systematically collect data on the volume of  prescription drugs and controlled substances they encounter at the mail  and carrier facilities. Without an accurate estimate of the volume of  importation of prescription drugs, federal agencies cannot determine the  full scope of the importation issue. Yet FDA officials have often testified  regarding the large and steadily increasing volume of packages containing  prohibited prescription drugs entering the United States through the  international mail and carrier facilities. CBP and FDA officials have said  that in recent years they have observed increasingly more packages  containing prescription drugs being imported through the mail facilities.  However, neither agency has complete data to estimate volume of  importation. For example, a CBP official recently testified that the agency  did not have data on the total number of packages containing imported  controlled substances. A CBP official at a mail facility told us that to  determine the total volume of prescription drug importation would require  that the CBP personnel inspect each mail item—which they currently do  not do, in part because mail from certain countries bypasses inspection— and tally those that were suspected of containing prescription drugs. This  official said that he did not have the resources at his facility for such an  undertaking. In addition, neither CBP nor FDA tracked the number of  packages suspected of containing prescription drugs that were held for  FDA review. FDA officials told us that CBP and FDA currently have no  mechanism for keeping an accurate count of the volume of illegally  imported drugs, because of the large volume of packages arriving daily  through the international mail and carriers. Furthermore, FDA officials  told us that FDA did not routinely track items that contained prescription  drugs potentially prohibited for import that they released and returned for  delivery to the recipient. However, they said that FDA had begun gathering  from the field information on the imported packages it handles, but as of  July 2005, this effort was still being refined.
CBP and FDA, in coordination with other federal agencies, have  conducted special operations to gain insight regarding the volume of  imported prescription drugs entering through selected mail facilities.  Generally, these were onetime, targeted efforts to identify and tally the  packages containing prescription drugs imported through a particular  facility during a certain time period and to generate information for  possible investigation. The limited data collected have shown wide  variations in volume. For example, CBP officials at one mail facility  estimated that approximately 3,300 packages containing prescription  drugs entered the facility in 1 week. CBP officials at another mail facility  estimated that 4,300 packages containing prescription drugs entered the  facility in 1 day. While these data provide some insight regarding the  number of packages containing prescription drugs at a selected mail  facility during a certain time period, the data are not representative of  other time periods or projectable to other facilities.
Debate continues over the estimated volume of prescription drugs  entering the United States through mail and express carrier facilities.  During congressional hearings over the past 4 years, FDA officials, among  others, have presented estimates of the volume of imported prescription  drugs ranging from 2 million to 20 million packages in a given year. Each  estimate has its limitations; for example, some estimates were  extrapolations from data gathered at a single mail facility. More recently, a  December 2004 HHS report stated that approximately 10 million packages  containing prescription drugs enter the United States—nearly 5 million  packages from Canada and another 5 million mail packages from other  countries. However, these estimates also have limitations, being partially  based on extrapolations from limited FDA observations at international  mail branch facilities. Specifically, FDA officials told us that FDA  developed its estimate for Canadian drugs entering the country using (1)  IMS Health estimates that 12 million prescriptions sold from Canadian  pharmacies were imported into the United States in 2003 and (2) FDA’s  experience during special operations at various locations from which it  concluded that there appeared to be about 2.5 prescriptions in each  package. According to FDA officials, the estimate for other countries was  an extrapolation using the estimated 5 million packages from Canada in  conjunction with FDA’s observations, likewise made during special  operations, that 50 percent of the mail packages enter from countries  other than Canada.
section_title: Safety of Prescription Drug Imports Is Not Assured
paragraphs: FDA officials have said that they cannot provide assurance to the public  regarding the safety and quality of drugs purchased from foreign sources,  which are largely outside of their regulatory system. Additionally, FDA  officials said that consumers who purchase prescription drugs from  foreign-based Internet pharmacies are at risk of not fully knowing the  safety or quality of what they are importing. They further said that while  some consumers may purchase genuine products, others may  unknowingly purchase counterfeit products, expired drugs, or drugs that  were improperly manufactured.
CBP and FDA have done limited analysis of the imported prescription  drugs identified during special operations, and the results have raised  questions about the safety of some of the drugs. For example, during a  special operation in 2003 to identify and assess counterfeit and potentially  unsafe imported drugs at four mail facilities, CBP and FDA inspected 1,153  packages that contained prescription drugs. According to a CBP report,  1,019, or 88 percent, of the imported drug products were in violation of the  Federal Food, Drug, and Cosmetic Act or the Controlled Substances  Import and Export Act. Some of the drugs were foreign versions of U.S.- approved drugs that are unapproved for import, including Lipitor (a  cholesterol-lowering drug), Viagra, and Propecia. Other drugs never had  FDA approval. For example, Taro-warfarin, an apparent unapproved  version of Warfarin, which is used to prevent blood clotting, was imported  from Canada. The drug raised safety concerns because its potency may  vary depending on how it is manufactured, and it requires careful patient  monitoring because it can cause life-threatening bleeding if not properly  administered. A CBP laboratory analyzed 180 of the 1,153 drugs inspected,  which showed that many of the imported drugs could pose safety risks.  The drugs tested included some that were withdrawn from the U.S. market  for safety reasons, animal drugs not approved for human use, and drugs  that carry risks because they require careful dosing or initial screening. In  addition, other drugs tested were found to contain controlled substances  prohibited for import, and some of the drugs contained no active  ingredients. Figure 2 illustrates the results of the CBP laboratory analysis.
In a past review we found that prescription drugs ordered from some  foreign-based Internet pharmacies posed safety risks for consumers.  Specifically, in a June 2004 report, we identified several problems  associated with the handling, FDA approval status, and authenticity of   21 prescription drug samples we purchased from Internet pharmacies  located in several foreign countries—Argentina, Costa Rica, Fiji, Mexico,  India, Pakistan, the Philippines, Spain, Thailand, and Turkey. Our work  showed that most of the drugs, all of which we received via consignment  carrier shipment or the U.S. mail, were unapproved for the U.S. market  because, for example, the labeling or the foreign manufacturing facility,  methods, and controls were not reviewed by FDA. Of the 21 samples:    None included dispensing pharmacy labels that provided instructions for  use, and only about one-third included warning information.
Thirteen displayed problems associated with the handling of the drug. For  example, three samples that should have been shipped in a temperature- controlled environment arrived in envelopes without insulation, and five  samples contained tablets enclosed in punctured blister packs, potentially  exposing them to damaging light or moisture.
Two were found to be counterfeit versions of the products we ordered.
Two had a significantly different chemical composition than that of the  product we had ordered.
We found fewer problems among 47 samples purchased from U.S. and  Canadian Internet pharmacies. Although most of the drugs obtained from  Canada were of the same chemical composition as that of their U.S.  counterparts, most were unapproved for the U.S. market. We said that it  was notable that we identified numerous problems among the samples we  received despite the relatively small number of drugs we purchased,  consistent with problems that had been recently identified by state and  federal regulatory agencies.
Similarly, during our current review, we observed that some prescription  drugs imported through the mail and carrier facilities were not shipped in  protective packages, including some wrapped in foil or in plastic bags. In  addition to being shipped without containers, the drugs also lacked  product identifications, directions for use, or warning labels. For some  drugs, the origin and contents could not be immediately determined by  CBP or FDA inspection. Figure 3 illustrates an example of drugs that were  sent without labeling.
Federal agencies and professional medical and pharmacy associations  have found that consumers, of any age, can obtain highly addictive  controlled substances from Internet pharmacies, sometimes without a  prescription or consultation with a physician. For example, a DEA official  recently testified that Internet pharmacies that offer to sell controlled  substances directly to consumers without a prescription and without  requiring consultation with a physician can increase the possibility of  addiction, access to counterfeit products, and adverse reactions to  medications. According to the Office of National Drug Control Policy,  Internet pharmacies that offer controlled substances bypass traditional  regulations and established safeguards and expose consumers to  potentially counterfeit, adulterated, and contaminated products. Both DEA  and ONDCP have found that the easy availability of controlled substances  directly to consumers over the Internet has significant implications for  public health, given the opportunities for misuse and abuse of these  addictive drugs.
The American Medical Association recently testified that Internet  pharmacies that offer controlled substances without requiring a  prescription or consultation with a physician contribute to the growing  availability and increased use of addictive drugs for nonmedical purposes.  To demonstrate the ease with which controlled substances can be  obtained via the Internet, the National Association of Boards of Pharmacy  received prescription drugs from four different Internet pharmacies.  From one of the Internet pharmacies, the association reported it received  a shipment of Valium—a schedule IV controlled substance used to treat  muscle spasm or anxiety—despite providing no prescription and the  height and weight information for a small dog. The association also  reported that 2 days after it received its shipment of   30 tablets of Xanax—a schedule IV controlled substance used to treat  anxiety—the Internet pharmacy sent daily refill reminders via electronic  mail.
section_title: Some Targeted Packages Containing Prescription Drugs Are Interdicted, but Many Others Are Not
paragraphs: In our July 2004 testimony, we reported that while some targeted packages  were inspected and interdicted, many others either were not inspected and  were released to the addressees or were released after being held for  inspection. At the time, FDA officials said that because they were unable  to process the volume of targeted packages, they released tens of  thousands of packages containing drug products that may violate current  prohibitions and could have posed a health risk to consumers. In August  2004, FDA issued standard operating procedures to prioritize package  selection, package examination, and admissibility determinations. While  the new procedures may encourage uniform practices at the mail facilities,  packages that contain potentially prohibited prescription drugs continue  to be released to the addressee. Recently, CBP also issued a new policy for  processing packages with controlled substances without using time- consuming seizure and forfeiture procedures. While the policy may reduce  processing time and encourage the interdiction of more controlled  substances, CBP officials do not know whether the new policy has had an  impact on the volume of prohibited prescription drug importation.
subsections: section_title: New Procedures Should Encourage Uniform Practices, but They Still Allow Many Packages Containing Prescription Drugs to Be Released
paragraphs: In our July 2004 testimony, we reported that CBP and FDA officials at  selected mail and carrier facilities used different practices and procedures  to inspect and interdict packages that contain prescription drugs. While  each of the facilities we visited targeted packages for inspection, the basis  upon which packages were targeted could vary and was generally based  on several factors, such as the inspector’s intuition and experience,  whether the packages originated from suspect countries or companies, or  were shipments to individuals. At that time, CBP officials told us that the  factors could also include intelligence gained from prior seizures,  headquarters, or other field locations. Specifically, officials at one facility  we visited targeted packages on the basis of the country of origin. At this  facility, FDA provided CBP with a list of seven countries to target, the  composition of which changed periodically, and asked that CBP hold the  packages they suspected of containing prescription drugs from those  countries. Typically, CBP officials at this facility released packages to the  addressee containing prescription drugs that were not from one of the  targeted countries.
Officials at another facility targeted packages based on whether the  packages were suspected of containing a certain quantity of prescription  drugs. At this facility, CBP officials held packages containing prescription  drugs that appeared to exceed a 90-day supply—a violation of one of the  criteria in FDA’s personal importation policy. If the package contained  prescription drugs, including in some cases controlled substances, that  appeared to be 90 pills or less, it was typically released. FDA officials at  this facility told us that every week CBP turned over to FDA hundreds of  packages that contained quantities of prescription drugs that appeared to  exceed the 90-day supply. However, the FDA officials said that they were  able to process a total of approximately 20 packages per day and, as a  result, returned many of the packages for release to the addressee. FDA  officials explained that 20 packages a day is an approximation because  some packages can take longer than others to inspect, particularly if the  packages contain many different types of drugs that need to be examined.
According to FDA officials and data, in fiscal year 2004, FDA field  personnel physically inspected approximately 20,800 packages containing  prescription drugs entering the United States through the international  mail facilities. Of the packages inspected, FDA’s data showed that 98  percent were refused entry and marked returned to sender and the  remaining, about 450, were released to the addressee. The FDA data  indicate the number of packages physically inspected by FDA personnel  and the results of that process; they do not specify the number of  individual prescription drugs or smaller packages of drugs within a larger  package. Most important, these data do not indicate the universe of  packages of prescription drugs coming through the mail facilities.
Figure 4 shows bins containing packages of suspected prescription drugs  being held for FDA review and possible inspection at one mail facility.
In August 2004, FDA issued standard operating procedures that, according  to FDA officials, have been adopted nationwide. According to FDA, the  purpose of the new procedures was to “provide a standard operating  environment for the prioritized selection, examination and admissibility  determination of FDA-regulated pharmaceuticals imported into the United  States via international mail.” Under the procedures, CBP personnel are to  forward to FDA personnel any mail items, from FDA’s national list of  targeted countries and based on local criteria, that appear to contain  prescription drugs. The procedures outline how FDA personnel are to  prioritize packages for inspection, inspect the packages, and make  admissibility determinations. Deviations from the procedures must be  requested by facility personnel and approved by FDA management. While  the new procedures should encourage processing uniformity across  facilities, many packages that contain prescription drugs are still released.
Specifically, according to the procedures, all packages forwarded by CBP  but not processed by FDA inspectors at the end of each workday are to be  returned for delivery by USPS to the recipient. However, according to the  procedures, packages considered to represent a significant and immediate  health hazard may be held over to the next day for processing.
CBP and FDA officials at two facilities told us that the new procedures  resulted in an increase in the number of packages CBP personnel refer to  FDA. Officials at one facility estimated that CBP referrals have increased  from approximately 500 to an average of 2,000 packages per day. The FDA  officials noted that the procedures did not resolve the heavy volume of  prescription drug importation or FDA’s ability to deal with the volume, nor  were they designed to do so. While the packages that are not targeted are  released without inspection, so are many packages that are targeted and  referred to FDA personnel. At one facility, FDA officials estimated that  each week they return without inspection 9,000 to 10,000 of the packages  referred to them by CBP. They said these packages were given to USPS  officials for delivery to the addressee. If this facility were to maintain that  level of release, about half a million packages per year would be delivered  to addressees.
section_title: New Controlled Substances Policy May Improve Interdiction Efforts, but Impact on Importation Is Unclear
paragraphs: In our July 2004 testimony, we reported that CBP officials were to seize  the illegally imported controlled substances they detected. However, at  that time, some illegally imported controlled substances were not seized  by CBP. For example, CBP officials at one mail facility told us that they  experienced an increased volume of controlled substances and, in several  months, had accumulated a backlog of over 40,700 packages containing  schedule IV substances. To keep the drugs from entering U.S. commerce  and to clear the backlog, a CPB official at the facility said that CBP’s  headquarters office granted them permission to send most of the drugs  back to the sender. CBP officials at another facility told us that certain  controlled substances were a priority and seized when detected; priority  substances included anabolic steroids (a category of schedule III drugs  that promote muscle growth and potentially boost athletic performance),  and gamma hydroxybutyrate (a schedule I drug that acts as a central  nervous system depressant). At this facility, other controlled substances  encountered that were not a priority and that were shipped in small  amounts, less than a 90-day supply, could be released to the addressee.  CBP officials at another facility we visited turned over packages they  suspected of containing controlled substances in small amounts to FDA  for processing. Neither returning an illegally imported controlled  substance to the sender nor releasing it to the addressee is in accordance  with federal law.
CBP field personnel said they did not have the resources to seize all the  controlled substances they detected. Officials said that the seizure process  can be time-consuming, taking approximately 1 hour for each package  containing controlled substances. According to CBP officials, when an  item is seized, the inspector records the contents of each package— including the type of drugs and the number of pills or vials in each  package. If the substance is a schedule I or II controlled substance, it is to  be summarily forfeited without notice, after seizure. However, if it is a  schedule III through V controlled substance, CBP officials are to notify the  addressee that the package was seized and give the addressee an  opportunity to contest the forfeiture by providing evidence of the  package’s admissibility and trying to claim the package at a forfeiture  hearing.
To address the seizure backlog and give CBP staff more flexibility in  handling controlled substances, in September 2004, CBP implemented a  national policy for processing controlled substances, schedule III through  V, imported through the mail and carrier facilities. According to the policy,  packages containing controlled substances should no longer be  transferred to FDA for disposition, released to the addressee, or returned  to the sender. CBP field personnel are to hold the packages containing  controlled substances in schedules III through V as unclaimed or  abandoned property as an alternative to a seizure. According to a CBP  headquarters official, processing a controlled substance as abandoned  property is a less arduous process because it requires less information be  entered into a database than if the same property were to be seized. Once  CBP deems the controlled substance to be unclaimed property, the  addressee is notified that he or she has the option to voluntarily abandon  the package or have the package seized. If the addressee voluntarily  abandons the package or does not respond to the notification letter within  30 days, the package will be eligible for immediate destruction. If the  addressee chooses to have the package seized, there would be an  opportunity to contest the forfeiture and claim the package, as described  above. CBP also instituted an on-site data collection system at  international mail and express carrier facilities to record schedule III  through V controlled substances interdicted using this new process.  From September 2004 to the end of June 2005, CBP reported that a total of  approximately 61,700 packages of these substances were interdicted,  about 61,500 at international mail facilities and 200 at express carrier  facilities.
Generally, CBP officials we interviewed told us that the recent policy  improved their ability to quickly process the volume of schedule III  through V controlled substances they detected. A CBP official at one  facility said that the abandonment process is faster than the seizure  process, as it requires much less paperwork. A CBP headquarters official  told us that the abandonment process takes an inspector at a mail facility  about 1 minute to process a package. He added that the new policy was  intended to eliminate the backlog of schedule III through V controlled  substances at the facilities. Figure 5 shows schedule III through V  controlled substances that were abandoned during a 1-month period at  one mail facility and awaiting destruction.
While the recent policy may have expedited processing, CBP officials in  the field and in headquarters said that they do not know whether the new  policy has had any impact on the volume of controlled substances illegally  entering the country that reach the intended recipient. Generally, CBP  officials do not know the extent of packages that contain controlled  substances that are undetected and released. For example, CBP officials at  one facility told us that they used historical data to determine the  countries that are likely sources for controlled substances and target the  mail from those countries. They do not know the volume of controlled  substances contained in the mail from the nontargeted countries. A CBP  official at another facility said that he believed the volume of controlled  substances imported through the facility had begun to decrease but had no  data to support this claim. One CBP official at a carrier facility told us that  because the express carrier environment is constantly changing with new  routes, service areas, and increasing freight volume and because  smuggling trends shift in response to past enforcement efforts, he could  not ascertain the quantities of packages containing controlled substances  that are undetected by CBP.
section_title: Packages Containing Prescription Drugs Can Bypass FDA Review at the Carrier Facilities
paragraphs: Packages containing prescription drugs can also bypass FDA inspection at  carrier facilities because of inaccurate information about the contents of  the package. Unlike packages at mail facilities, packages arriving at carrier  facilities we visited are preceded by manifests, which provide information  from the shipper, including a description of the packages’ contents. While  the shipments are en route, CBP and FDA officials are to review this  information electronically and select packages they would like to inspect  when the shipment arrives. FDA officials at two carrier facilities we  visited told us they review the information for packages described as  prescription drugs or with a related term, such as pharmaceuticals or  medicine. CBP and FDA officials told us that there are no assurances that  the shipper’s description of the contents is accurate. The FDA officials at  the carrier facilities we visited told us that if a package contains a  prescription drug but is inaccurately described, it would not likely be  inspected by FDA personnel.
According to FDA officials, FDA field personnel are not continually on-site  at the two carrier facilities we visited. At the FDA field office that has  responsibility for inspecting packages at one carrier facility, we observed  FDA field personnel reviewing electronic information regarding packages  that were en route to the carrier facility. The official said that the field  office has electronic information regarding an average of 400 packages per  day available for review. If the shipper does not provide enough  information about its package, FDA field personnel can request that the  carrier detain the package until more information is provided  electronically or until the FDA personnel can visit the facility to conduct a  physical inspection of the package. The number of physical inspections at  the facilities we visited varied depending on the number of packages  electronically reviewed. FDA field personnel, responsible for inspection at  the other carrier facility, reported that in September 2004 they  electronically requested that an average of 20 packages per day be held at  the facility for a physical inspection. However, on occasion when the FDA  personnel went to the facility to conduct the inspection, the packages  were unavailable because they could not be found, had been delivered to  the recipient by the carrier, or had been returned to the shipper. According  to FDA headquarters officials, since our visit, FDA field personnel may  now be visiting the carrier facility on a more routine basis.
In contrast, CBP inspectors are located on-site at the carrier facilities we  visited. As a result, CBP personnel are able to inspect packages upon  arrival of the shipment. In addition, according to CBP officials at the  facility, CBP’s on-site presence allows the inspectors to conduct random  inspections, on a routine basis, of packages as they are processed at the  facility. Instead of relying solely on the information provided by the  shipper, CBP personnel said they conduct random inspections, on a daily  basis, as another means to identify items that may be unapproved for  import. CBP officials told us that they conduct these inspections because  the shipper’s information can be inaccurate. During our visit we observed  the CBP personnel randomly inspect several hundred packages selected.  During these random inspections, CBP inspectors told us that they often  come across packages containing noncontrolled prescription drugs, which  they will set aside for FDA inspectors. For example, during a random  inspection, CBP officials found and held for FDA 13 packages containing a  human growth hormone—prohibited from import—that were inaccurately  described as glassware. In contrast, according to FDA field personnel with  inspection responsibility at the two carrier facilities we visited, few  random inspections of packages were performed and when they occurred  they were typically part of a special operation. For example, an FDA field  official told us that FDA personnel planned to perform one random  inspection effort per year.
CBP officials told us that they would like to have FDA personnel on-site to  improve coordination efforts. One CBP Port Director said that he would  like to have FDA personnel on-site to share data, perform analysis to  identify trends from CBP’s referrals, and be available to immediately  review prescription drugs. A CBP headquarters official also said that it  would be helpful if FDA personnel were on-site to enable CBP officials to  confer with them to identify controlled substances that are not clearly  labeled. FDA officials told us that because FDA personnel review  information regarding the packages electronically, there was no advantage  to being physically on-site. Further, they said the responsible district can  supply personnel to physically work at a given carrier facility for field  examinations on an as-needed basis. FDA officials also noted that FDA is  not reimbursed by the carriers to maintain staff on-site. By contrast,  private express carriers reimburse the federal government for the  personnel and equipment costs of the CBP staff located on-site. FDA  officials said that there is not a provision under current law that would  enable carriers to reimburse FDA so that it could maintain an on-site  presence.
section_title: Factors beyond Inspection and Interdiction Complicate Efforts to Enforce the Prohibitions on Personal Importation of Prescription Drugs
paragraphs: We identified three factors beyond inspection and interdiction that have  complicated federal efforts to enforce the prohibitions on prescription  drugs imported for personal use: (1) the volume of importation has  strained limited federal resources; (2) Internet pharmacies, particularly  foreign-based sites, can operate outside of the U.S. regulatory system for  noncontrolled and controlled prescription drugs and can evade federal law  enforcement actions; and (3) current law requires that FDA notify  addressees that their packages have been detained because they appear  unapproved for import and give them the opportunity to provide  admissibility evidence regarding their imported items.
subsections: section_title: Volume of Imports Can Strain Federal Resources
paragraphs: The current volume of prescription drug imports, coupled with competing  agency priorities, has strained federal inspection and interdiction  resources allocated to the mail facilities. CBP and FDA officials told us  that the increased incidence of American consumers ordering drugs over  the Internet in recent years has significantly contributed to the increase in  imports through the international mail. CBP officials said that they are  able to inspect only a fraction of the large number of mail and packages  shipped internationally. In 2004, FDA testified that each day thousands of  individual packages containing prescription drugs are imported illegally  into the United States. FDA officials have said that the large volume of  imports has overwhelmed the resources they have allocated to the mail  facilities. Officials add that they have little assurance that the available  field personnel are able to inspect all the packages containing prescription  drugs illegally imported for personal use through the mail.
Agencies have multiple priorities, which can affect the resources they are  able to allocate to the mail and carrier facilities. For example, FDA has  multiple areas of responsibility, which include, among other things,  regulating new drug product approvals, the labeling and manufacturing  standards for existing drug products, and the safety of a majority of food  commodities and cosmetics, which, according to FDA officials, all go to  FDA’s mission of protecting the public health while facilitating the flow of  legitimate trade. CBP’s primary mission is preventing terrorists and  terrorist weapons from entering the United States while also facilitating  the flow of legitimate trade and travel. FDA and CBP personnel operate in  multiple venues, such as land border crossings and seaports. DEA’s  multiple priorities include interdicting illicit drugs such as heroin or  cocaine, investigating doctors and prescription forgers, and pursuing  hijackings of drug shipments. DEA officials told us that they have limited  resources and often have to balance efforts to address prescription drug  importation with their other priorities.
The Medicare Prescription Drug, Improvement, and Modernization Act of  2003 required the HHS Secretary to conduct a study on the importation of  drugs that included a review of the adequacy of federal agency resources  to inspect and interdict drugs unapproved for import. The report, issued  in 2004, states that substantial resources are needed to prevent the  increasing volume of packages containing small quantities of drugs from  entering the country. The Secretary found that despite agency efforts,  including those with CBP, FDA currently does not have sufficient  resources to ensure adequate inspection of the current volume of personal  shipments of prescription drugs entering the United States.
CBP is also in the early stages of assessing the resources it needs at the  mail facilities to address the volume of controlled substance imports.  However, CBP officials admit that an assessment of resource needs is  difficult because they do not know the scope of the problem and the  impact of the new procedures. A CBP official told us that CBP has a  statistician working on developing estimates on the volume of drugs  entering mail facilities; however, he was uncertain whether this effort  would be successful or useful for allocating resources. Likewise, in March  2005, FDA officials told us that they had begun to gather from the field  information on the imported packages it handles, such as the number of  packages held, reviewed, and forwarded for further investigation.  However, as of July 2005, they could not provide any data because,  according to the officials, this effort was new and still being refined.
section_title: Internet Pharmacies Challenge Law Enforcement Efforts
paragraphs: Internet pharmacies, particularly foreign-based sites, which operate  outside the U.S. regulatory system, pose a challenge for regulators and law  enforcement agencies. In our 2004 report, we described how traditionally,  in the United States, the practice of pharmacy is regulated by state boards  of pharmacy, which license pharmacists and pharmacies and establish and  enforce standards. 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. However, the Internet allows online  pharmacies and physicians to anonymously reach across state and  national borders to prescribe, sell, and dispense prescription drugs  without complying with state requirements or federal regulations  regarding imports. Recently, FDA officials have testified that inadequately  regulated foreign Internet sites have become portals for unsafe and illegal  prescription drugs. FDA officials state that if a consumer has an adverse  drug reaction or other problem, he or she may have little to no recourse  because the operator of the pharmacy is often not known and FDA has  limited authority to take action against foreign operators.
The nature of the Internet has challenged U.S. law enforcement agencies  investigating Internet pharmacies, particularly foreign-based sites. Internet  sites can easily be installed, moved, or removed in a short period of time.  FDA officials said that one Internet site can be composed of multiple  related sites and links, thereby making their investigations complex and  resource intensive. This fluidity makes it difficult for law enforcement  agencies to identify, track, monitor, or shut down those sites that operate  illegally. Further, FDA officials said that some Internet pharmacies do not  disclose enough information on their Web sites to allow consumers to  determine if the drugs they purchased were approved in the United States  and dispensed according to state and federal laws. Some Internet  pharmacies also do not disclose enough or accurate information regarding  the source of the drugs they offer. An Internet pharmacy can claim that the  drugs they offer originate in one country, but the drugs may actually be  manufactured in another country. Similarly, the anonymous nature of the  Internet allows consumers of any age to obtain drugs without a legitimate  medical need.
According to FDA, when the Internet is used for an illegal sale of  prescription drugs, to conduct an investigation they may need to work  with the Department of Justice to establish grounds for a case, develop  charges, and take action as they would if another sales medium, such as a  store or magazine, had been used. Investigations can be more difficult  when they involve foreign-based Internet sites, whose operators are  outside of U.S. boundaries and may be in countries that have different  drug approval and marketing approaches than the United States has. For  example, according to DEA officials, drug laws and regulations regarding  controlled substances vary widely by country. DEA officials told us their  enforcement efforts with regard to imported controlled substances are  hampered by the different drug laws in foreign countries. Internet  pharmacy sites can be based in countries where the marketing and  distribution of certain controlled substances are legal. Steroids, for  example, sold over the Internet may be legal in the foreign country in  which the online pharmacy is located.
Federal agencies can face challenges when working with foreign  governments to share information or develop mechanisms for cooperative  law enforcement. For example, FDA officials have testified that they  possess limited investigatory jurisdiction over sellers in foreign countries  and have had difficulty enforcing the law prohibiting prescription drug  importation when foreign sellers are involved. A DEA official told us that  the agency introduced a resolution at the March 2004 International  Narcotics Control Board conference in Vienna, Austria, to encourage  member states to work cooperatively on Internet pharmacy issues.  However, the DEA official told us that it was difficult to convince some  foreign governments that the illegal sales of prescription drugs over the  Internet is a global problem and not restricted to the United States.
FDA and DEA officials told us that they work with commercial firms,  including express carriers, credit card organizations, Internet providers,  and online businesses to obtain information to investigate foreign  pharmacies, but these investigations are complicated by legal and practical  considerations. FDA and DEA officials said that the companies have been  willing to work with government agencies to stop transactions involving  prescription drugs prohibited from import, and some have alerted federal  officials when suspicious activity is detected. However, officials also  identified current legal and practical considerations that complicated  obtaining information from organizations, such as credit card  organizations. These considerations included privacy laws; federal law  enforcement agencies’ respective subpoena authority, priorities, and  jurisdictions; and the ease with which merchants engaged in illegal activity  can enter into a new contract with a different bank to use the same  payment system.
For example, privacy laws sometimes limit the extent to which companies  (e.g., credit card organizations) will provide information to federal  agencies about parties to a transaction. According to FDA, DEA, and ICE  officials, credit card organizations and banks and other financial  institutions that issue credit cards will not provide to the agencies  information about the parties involved in the transaction without a  subpoena. Representatives from the credit card companies we contacted  explained that these issues generally are resolved if the agency issues a  properly authorized subpoena for the desired information. (See app. III  for information on federal enforcement agencies’ work with credit card  organizations to enforce prohibitions on prescription drug importation.)
section_title: Notification Process Challenges Enforcement Efforts
paragraphs: FDA headquarters officials said that packages that contain prescription  drugs for personal use that appear to be prohibited from import pose a  challenge to their enforcement efforts because these packages cannot be  automatically refused. Before any imported item is refused, the current  law requires FDA to notify the owner or consignee that the item has been  held because it appears to be prohibited and give the product’s owner or  consignee an opportunity to submit evidence of admissibility. If the  recipient does not respond or does not present enough evidence to  overcome the appearance of inadmissibility, then the item can be returned  to the sender, or in some cases destroyed.
FDA officials told us that this requirement applies to all drug imports that  are held under section 801(a) of the Federal Food, Drug, and Cosmetic  Act. Nonetheless, they said that they believe this notification process is  time consuming because each package must be itemized and entered into  a database; a letter must be written to each addressee; and the product  must be stored. The process can take up to 30 days per import—and can  hinder their ability to quickly process packages containing prescription  drugs prohibited from import. According to FDA investigators, in most  instances, the addressee does not present evidence to support the drugs’  admissibility, and the drugs are ultimately provided to CBP or the U.S.  Postal Service for return to sender. FDA headquarters officials told us that  the Standard Operating Procedures, introduced in August 2004 and  discussed earlier in this report, were an attempt to help FDA address the  burden associated with the notification process because it was designed to  focus resources on packages containing drugs considered to be among the  highest risk.
FDA concerns about the notification process are not new. In testimony  before Congress, FDA and the Secretary of HHS raised concerns about the  notification process, noting that it is time-consuming and resource  intensive. However, FDA’s testimony did not propose any legislative  changes to address the concerns it identified. In May 2001, FDA’s Acting  Principal Deputy Commissioner wrote a memorandum to the Secretary of  HHS expressing concern about the growing number of drugs imported for  personal use and the dangers they posed to public health. The  memorandum explained that because of the notice and opportunity to  respond requirements, detaining and refusing entry of mail parcels was  resource intensive. The Acting Principal Deputy Commissioner proposed,  among other things, the removal of the requirement that FDA issue a  notice before it could refuse and return personal use quantities of FDA- regulated products that appear violative of the Food, Drug, and Cosmetic  Act. He noted that removal of the notification requirement would likely  require legislation, but without this change, FDA could not effectively  prohibit mail importation for personal use.
As of July 2005, according to FDA officials and an HHS official, the  Secretary had not responded with a specific legislative proposal to change  FDA’s notification requirement. FDA officials said that there are some  complicating issues associated with eliminating the notification  requirement. For example, they said that one of the arguments against  eliminating the notification requirement is the importance of providing due  process, which basically gives individuals the opportunity to present their  case as to why they should be entitled to receive the property, in this case  prescription drugs that they ordered from a foreign source. Another is to  what extent the law should be changed to cover all imported prescription  drugs and other products. In addition, USPS indicated that any discussion  of options to expedite the processing and disposition of prescription drugs  must consider international postal obligations, specifically the  requirements of the Universal Postal Union (UPU). FDA officials said that  currently, the notification requirement also applies to large commercial  quantities of prescription drugs and other nonpharmaceutical products for  which the requirement is not a problem. They said it has become a burden  only because FDA and CBP are overwhelmed with a large volume of small  packages.
FDA officials said that they have considered other options for dealing with  this issue, such as summarily returning each package to the sender  without going through the process. However, they said that the law would  likely need to be changed to allow this, and, as with the current process,  packages that are returned to the sender could, in turn, be sent back by  the original sender to go through the process again. They said that another  option might be destruction, but they were uncertain whether they had the  authority to destroy drugs FDA intercepts; they indicated that the  authority might more likely lie with CBP. Regardless, FDA officials said  that whatever approach was adopted, FDA might continue to encounter a  resource issue because field personnel would still need to open and  examine packages to ascertain whether they contained unapproved  prescription drugs.
section_title: Federal Efforts to Coordinate Law Enforcement Activities Could Benefit from a Strategic Framework
paragraphs: Federal agencies have been taking steps to address Internet sales of  prescription drugs since 1999, but these efforts have not positioned them  to successfully prevent the influx of prescription drugs that are being  imported through foreign pharmacies. CBP has recently organized a task  force to coordinate federal efforts related to prescription drugs imported  for personal use. This task force appears to be a step in the right direction.  However, its efforts could be further enhanced if the task force  established a strategic framework to promote accountability and guide  resource and policy decisions. In January 2004, CBP organized an  interagency task force to address various issues associated with  unapproved prescription drugs entering the United States from foreign  countries. Although CBP, FDA, ONDCP, DEA, and ICE appear to be  working together to address these very complex issues, their efforts could  be enhanced by a strategic framework that guides resource and policy  decisions and promotes accountability. Such a framework that establishes  measurable, quantifiable goals and strategies for achieving these goals,  including a determination of resources needed to achieve the goals, would  enhance the ability of agency officials and congressional decision makers  to ensure accountability and consistent and focused attention to enforcing  the prohibitions on personal importation.
Congress enacted the Government Performance and Results Act of 1993 to  have agencies focus on the performance and results of programs, rather  than on program resources and activities. The principles of the act include  (1) establishing measurable goals and related measures, (2) developing  strategies for achieving results, and (3) identifying the resources that will  be required to achieve the goals. The act does not require agencies to use  these principles for individual programs, but our work related to the act  and the experience of leading organizations have shown that a strategic  approach or framework is a starting point and basic underpinning for  performance-based management—a means to strengthen program  performance. A strategic framework can serve as a basis for guiding  operations and help policy makers, including congressional decision  makers and agency officials, make decisions about programs and  activities.
Our work has also shown that a strategic framework can be useful in  providing accountability and guiding resource and policy decisions,  particularly in relation to issues that are national in scope and cross  agency jurisdictions, such as prescription drug importation. When  multiple agencies are working to address aspects of the same problem,  there is a risk that overlap and fragmentation among programs can waste  scarce funds, confuse and frustrate program customers, and limit overall  program effectiveness. Use of a strategic framework may help mitigate  this risk.
subsections: section_title: Federal Agencies Have Recently Begun to Coordinate Efforts to Focus on Prescription Drugs Imported for Personal Use
paragraphs: Since 1999, federal law enforcement and regulatory agencies have  organized various task forces and working groups to address issues  associated with purchasing prescription drugs over the Internet; however,  recent efforts have begun to focus particular attention on imported  prescription drugs. For example, according to an FDA official, many of  FDA’s efforts, started in 1999, focused on Internet pharmaceutical sales by  illicit domestic pharmacies and the risks associated with purchasing those  drugs, rather than drugs that are being imported from foreign countries.  This official said that although FDA had established working groups and  advanced media campaigns to address problems associated with drugs  purchased over the Internet from domestic sources, imported drugs have  added a new dimension that was only incidentally recognized during  efforts begun in 1999. He said that the plans developed by FDA in 1999 are  still viable as far as domestic sales are concerned, but they have not been  refocused to reflect concerns about imported prescriptions and did not  position federal law enforcement agencies to anticipate the increased  volume of drugs that are imported by individuals.
More recent efforts have focused on prescription drugs entering  international mail and express carrier facilities. In January 2004, the CBP  Commissioner initiated an interagency task force on pharmaceuticals,  composed of representatives from CBP, FDA, DEA, ICE, and ONDCP as  well as legal counsel from the Department of Justice. According to the  Commissioner, the proposal to create the task force was prompted by  “intense public debate and congressional scrutiny, which has resulted in  increasing pressure being applied to regulatory and law enforcement  agencies to develop consistent, fair policies” to address illegal  pharmaceuticals entering the United States. The Commissioner proposed  that the task force achieve five specific goals, and according to a CBP  official, five working groups were established to achieve these goals.  Figure 6 shows the task force goals, the five working groups, and the goals  of each working group.
A CBP official told us that the task force is designed to foster cooperation  among the agencies responsible for enforcing the laws governing  prescription drugs imported for personal use. The task force was created  to go beyond interdiction at the mail and carrier facilities. The official also  said that the task force was fashioned to deal with supply and demand  issues, thereby reducing the volume of drugs entering these facilities. For  example, on the demand side, the public awareness working group is  responsible for conveying information about the health and safety risks of  imported prescription drugs, and on the supply side, the working  cooperatively with industry group is responsible for, among other things,  ways of identifying rogue Internet sites. CBP officials and other members  of the task force provided examples of activities being carried out or  planned by task force working groups that are discussed below.
The working group on mail and express consignment operator facilities  procedures has carried out special operations at five international mail  and three express carrier facilities to examine parcels suspected of  containing prohibited prescription drugs over specific periods of time,  such as 2 or 3 days. While similar operations have occurred since 2000, a  CBP official told us that those conducted under the task force are  multiagency efforts. Among other things, task force members gather data  about the source, type, and recipients of the drugs and test the contents of  the parcels to determine whether they are counterfeit or otherwise  prohibited. These operations are expected to continue during the  remainder of 2005 at all of the remaining mail facilities and some of the  carrier facilities.
The working group on targeting/data research is using the results of  special operations to analyze data retrieved during the special operations  and determine how these data can be used to guide future operations and  enforcement efforts. Also, ICE was working with CBP and the government  of an Asian country to identify and track controlled substances destined  for the United States. ICE plans to use this approach to identify and take  possible law enforcement action against illegal enterprises.
The working group on increasing public awareness has been developing  and disseminating public service announcements on the risks associated  with purchasing drugs over the Internet. The working group has placed  public service announcements on the FDA and CBP Web sites and is  coordinating with FDA on its efforts, ongoing since 1999, to disseminate  similar material in magazines, online, and in pharmacies. Also, the working  group has entered into an agreement with a major Internet service  provider and others to have a public service announcement link on screen  when someone tries to access online pharmacy sites.
The working group on working cooperatively with industry has met with  Internet businesses, such Internet service providers and companies that  operate search engines, to discuss how task force members can work with  Internet businesses to stem the flow of imported drugs coming into the  country, including discussing standards for identifying legitimate Web  sites. It has also met with representatives of express carriers and plans to  meet with representatives of credit card organizations in late summer  2005.
In addition, task force members are working with ONDCP to address the  importation of controlled substances through international mail and  carrier facilities. In October 2004, ONDCP issued a plan for addressing  demand and trafficking issues associated with certain man-made  controlled substances—such as pain relievers, tranquilizers, and  sedatives. Among other things, ONDCP recommended that DEA, CBP,  ICE, State Department, National Drug Intelligence Center, and FDA work  with USPS and private express mail delivery services to target illegal mail  order sales of chemical precursors, synthetic drugs, and pharmaceuticals,  both domestically and internationally. ONDCP officials said that a  multiagency working group is meeting to discuss what can be done to  confiscate these controlled substances before they enter the country. An  ONDCP official said that participants at these meetings included officials  from CBP, USPS, and DEA.
Finally, USPS is exploring what additional steps it can take to further help  the task force. Although USPS has participated in task force activities,  USPS officials said USPS is concerned about a conflict between its  mission to keep the mail moving and whether it is positioned to determine  the admissibility of mail. USPS officials said that they proposed, during a  July 2004 hearing, the possibility of cross-designating U.S. Postal  Inspectors with Customs’ authority so that Postal Inspectors can conduct  warrant-less searches, at the border, of incoming parcels or letters  suspected of containing illegal drugs. According to USPS officials, such  authority would facilitate interagency investigations. They said that their  proposal has yet to be finalized with CBP. In addition, internationally,  USPS has drafted proposed changes to the U.S. listing in the Universal  Postal Union List of Prohibited Articles. A U.S. Postal Service official told  us that USPS is awaiting a response to a letter it sent to FDA last year  requesting FDA’s views on the proposed changes. The official said that,  without FDA input, USPS does not have the expertise to determine  whether the proposed changes are accurate. In August 2005, FDA officials  said that after receiving the letter last year, they met with USPS officials  regarding drug importation, including this proposal. However, according  to FDA officials, USPS had not subsequently engaged FDA on this  particular issue, and FDA did not believe USPS was awaiting a formal  written response. FDA officials stated that if USPS would like to discuss  this matter further, they would be happy to work with USPS.
section_title: Strategic Framework Would Further Enhance Task Force Efforts
paragraphs: Although the task force has taken positive steps toward addressing issues  associated with enforcing the laws on personal imports, it has not fully  developed a strategic framework that would allow the task force to  address many of the challenges we identify in this report. Carrying out  enforcement efforts that involve multiple agencies with varying  jurisdictions is not an easy task, especially since agencies have limited  resources and often conflicting priorities. The challenges identified in this  report could be more effectively addressed by using a strategic framework  that more clearly defines the scope of the problem by estimating the  volume of drugs entering international mail and carrier facilities,  establishes milestones and performance measures, determines resources  and investments needed to address the flow of imported drugs entering  the facilities and where those resources and investments should be  targeted, and evaluates progress.
Our review showed that the task force has already begun to establish some  elements of a strategic framework, but not others. For example:  In light of the Commissioner’s January 2004 memo discussed earlier, the  task force has a clear picture about its purpose and why it was created.  However, it has not defined the scope of the problem it is trying to address  because, as discussed earlier, CBP and FDA have yet to develop a way to  estimate the volume of imported prescription drugs entering specific  international mail and carrier facilities. Without doing so, it is difficult to  assess what resources are necessary to effectively inspect parcels and  interdict those that contain unapproved drugs.
Whereas the task force and individual working groups have goals that  state what they are trying to achieve, the task force has not established  milestones and performance measures to gauge results. A CBP official said  that the goals are intended to be guidelines rather than goals to be  measured; he would expect progress or results to be measured within the  context of strategic plans prepared by individual agencies. However,  without task force-specific milestones and performance measures, it is  difficult to measure improvement over time and ensure accountability,  particularly if the goals and measures of individual task force members do  not directly address, or are not in harmony with, the goals of the task  force.
The task force has not addressed the issue of what its efforts will cost so  that it can target resources and investments, balancing risk reduction with  costs and considering task force members’ other law enforcement  priorities. Instead, according to a CBP official, working group projects are  done on an ad hoc basis wherein resources are designated for specific  operations. Nonetheless, the absence of cost and resource assessments  makes effective implementation harder to achieve because over time,  alternative agency priorities and resource constraints may hinder the  ability of the task force to meet its goals.
We acknowledge that such a strategic framework needs to be flexible to  allow for changing conditions, but it could be helpful to organize it in a  logical flow, from conception to implementation. Specifically, the  strategy’s purpose leads to definition of the problems and risks it intends  to address, which in turn leads to specific actions for tackling those  problems and risks, allocating and managing appropriate resources,  identifying different organizations’ roles and responsibilities, and finally  integrating action among all the relevant parties and implementing the  strategy.
Advancing a strategic framework could establish a mechanism for  accountability and oversight and set the stage for defining specific  activities needed to achieve results and specific performance measures for  monitoring and reporting on progress. In so doing, task force officials  could measure progress over time, identify new and emerging barriers or  obstacles to carrying out goals and objectives, develop strategies to  overcome them, and inform decision makers about the implications of  taking or not taking specific actions. For example, CBP, FDA, and the  other agencies could work jointly to develop statistically valid estimates of  the number of parcels suspected of containing imported prescription  drugs entering particular facilities and begin to develop realistic risk-based  estimates of the number of CBP and FDA staff needed to interdict parcels  at mail facilities.
Task force members could also take steps to explore how they can work  more collaboratively and strategically with private organizations, such as  credit card organizations and express carriers. In doing so, task force  members and representatives of these organizations could examine what  can be done within the context of current law and establish strategies and  goals for overcoming any practical considerations that act as barriers to  enforcing the prohibition on imported pharmaceuticals, including  controlled substances. They could also identify any legislative barriers  they face in aggressively enforcing the prohibition and work together to  develop legislative proposals aimed at stemming the flow of imported  prescription drugs into the country.
In addition, agencies could work collaboratively among themselves to  examine the resources and investments needed to address particular  strategies. Any effort to implement task force objectives would require  sustained high-level leadership and commitment to ensure that resources  are available to carry out task force goals, commensurate with the goals  and priorities of the individual agencies involved with the task force.  According to a CBP official involved in the task force, agencies have made  a high-level commitment to supporting the task force. Nonetheless, in the  absence of a strategic framework and, in particular, measurable goals and  milestones, there is little assurance that this commitment will continue as  the goals and priorities of individual agencies change.
A strategic framework could also enable the task force to adjust to  changing conditions. As mentioned earlier, FDA had developed plans and  initiated steps in 1999 to deal with Internet sales of prescription drugs, but  most of those efforts focused on domestic sales. However, plans to  address Internet sales had not been refocused to reflect prescriptions  imported from foreign countries for personal use, partly because FDA and  other agencies did not anticipate that the volume of imported drugs would  overwhelm available resources. A strategic framework, with ongoing  problem definition and risk assessment, might help task force members,  including FDA and others to identify the impact of this emerging threat  and give the task force members the opportunity to adjust their  enforcement strategies to address the threat on a proactive, rather than a  reactive, basis. It also might help them consider interrelationships  between the enforcement strategies and priorities of the task force and  their own strategies and priorities.
Furthermore, a strategic framework could help agencies adjust to  potential changes in the law governing the importation of prescription  drugs for personal use. During recent sessions of Congress, members  introduced a number of bills that could have changed how personal  prescription drug imports were treated under the law. Some proposals  would have allowed importation of selected prescription drugs under  certain conditions, for example, allowing importation from certain  countries, such as Canada. Another proposal would have maintained the  current prohibitions, but would have allowed for expedited disposal of  illegally imported prescription drugs, such as controlled substances  available by prescription. Those bills that would have allowed some  personal importation also included provisions for expediting the process  of disposing of those drugs that still may not be imported for personal use.  Although none of these changes were adopted, continued congressional  interest could prompt changes in the future. If that occurred, a strategic  framework could better position agencies to adjust to any changes;  identify any new threats or vulnerabilities; and redefine strategies, roles,  and responsibilities.
section_title: Conclusions
paragraphs: Enforcing the laws governing prescription drug imports for personal use is  a complex undertaking that involves multiple agencies with various  jurisdictions and differing priorities. We acknowledge these complexities,  but current inspection and interdiction efforts at the international mail  branches and express carrier facilities have not prevented the reported  substantial and growing volume of prescription drugs from being illegally  imported from foreign Internet pharmacies into the United States. CBP  and other agencies have taken a step in the right direction by establishing  a task force designed to address many of the challenges discussed in this  report. Although agencies responsible for enforcing these laws have a  mechanism in place to jointly address the threat posed by prohibited and  sometimes addictive drugs entering the country via the international mail  and express carriers, many packages that may contain these drugs enter  the United States daily. Furthermore, according to officials, resources are  strained as the volume of prescription drugs entering the country is large  and increasing.
Our past work has shown how a strategic framework can be useful in  promoting accountability and guiding policy and resource decisions. In the  case of the task force, a strategic framework that facilitates  comprehensive enforcement of prescription drug importation laws and  measures results would provide it an opportunity to better focus agency  efforts to stem the flow of prohibited prescription drugs entering the  United States. The task force could become more effective as it becomes  more accountable. An assessment of the scope of the problem would help  the task force prioritize activities and help ensure that resources are  focused on the areas of greatest need. With milestones and performance  measures, it could be able to better monitor progress and assess efforts to  enforce the laws. An analysis of resources and investments is critical  because of current resource constraints, a point highlighted by the  Secretary of Health and Human Services’ report under the Medicare  Modernization Act. Moreover, without these elements culminating in  concrete plans for implementation, it will be difficult for the task force to  maximize effectiveness in reducing the flow of prohibited imported  prescription drugs into the United States.
In addition to the broader issues being addressed by the task force, FDA  has said it faces a significant challenge handling the substantial volume of  prescription drugs imported for personal use entering international mail  facilities. Specifically, in recent years, FDA has expressed continuing  concern to Congress that it encounters serious resource constraints  enforcing the law at mail facilities because packages containing personal  drug imports cannot automatically be refused. Instead, under current law,  FDA is to notify recipients that they are holding packages containing drugs  that appear to be prohibited from import and give them the opportunity to  provide evidence of admissibility. FDA has stated that it cannot effectively  enforce the law unless the requirement to notify recipients is changed.  FDA has suggested that the HHS Secretary consider proposing changes to  this requirement, but the HHS Secretary has not yet responded with a  legislative proposal. Although there may be complex issues associated  with changing the requirement to notify, including an individual’s due  process right to provide evidence of admissibility and consideration of  Universal Postal Union requirements, assessing the ramifications of such a  proposal would help decision makers as they consider how best to address  FDA’s resource constraints and responsibility to enforce the law and  protect the health and safety of the American public.
section_title: Recommendations
paragraphs: To help ensure that the government maximizes its ability to enforce laws  governing the personal importation of prescription drugs, we recommend  that the CBP Commissioner, in concert with ICE, FDA, DEA, ONDCP, and  USPS, develop and implement a strategic framework for the task force  that would promote accountability and guide resource and policy  decisions. At a minimum, this strategic framework should include    establishment of an approach for estimating the scope of the problem,  such as the volume of drugs entering the country through mail and carrier  facilities;    establishment of objectives, milestones, and performance measures and a  methodology to gauge results;    determination of the resources and investments needed to address the  flow of prescription drugs illegally imported for personal use and where  resources and investments should be targeted; and    an evaluation component to assess progress, identify barriers to achieving  goals, and suggest modifications.
In view of the FDA’s continuing concern about the statutory notification  requirement and its impact on enforcement, we also recommend that the  Secretary of HHS assess the ramifications of removing or modifying the  requirement, report on the results of this assessment, and, if appropriate,  recommend changes to Congress.
section_title: Agency Comments and Our Evaluation
paragraphs: We requested comments on a draft of this report from the Secretary of  Homeland Security, Attorney General, Director of the Office of National  Drug Control Policy, Secretary of Health and Human Services, and  Postmaster General. DHS, DEA, ONDCP, HHS, and USPS provided written  comments, which are summarized below and included in their entirety in  appendixes IV through VIII.
DHS generally agreed with the contents of our report. Since our  recommendation that the CBP-led task force develop and implement a  strategic framework to address prescription drug importation issues  affects other agencies, DHS said that CBP would convene a task force  meeting to discuss our report and recommendation and is to provide us  with additional information after the meeting.
Responding for DOJ, DEA generally agreed with our recommendation that  the CBP task force develop and implement a strategic framework.  Specifically, DEA agreed that a strategic framework can be useful in  promoting accountability and guiding policy and resource decisions, but it  said that the interagency task force is a cooperative initiative and DEA  must balance priorities in accordance with agency mandates. DEA also  said that its strategic plan clearly establishes a framework to articulate  agency priorities and assess its performance. Noting that our report  acknowledges that such a framework needs to be flexible to allow for  changing conditions, DEA stated that, in concert with other task force  agencies, it will support the CBP Commissioner’s strategic framework for  the interagency task force.
ONDCP generally concurred with our recommendation that the CBP-led  task force develop and implement a strategic framework. ONDCP also  “strongly” suggested that the ONDCP-led Synthetic Drug Interagency  Working Group play a significant role in integrating prescription drug  considerations with all of the other synthetic drug concerns that  potentially inflict harm on our society. ONDCP noted that our report  documented well the problems associated with effectively policing  Internet purchases and identified the significance played by credit card  use as a facilitator of the problem. In addition, ONDCP stated that it  encouraged law enforcement proposals that may curtail some of these  dangerous practices and concurred with our identification of the  cumbersome nature of currently required enforcement practices dealing  with the use of the mails to transfer illicit narcotics.
HHS generally concurred with both recommendations. With regard to the  strategic framework, HHS said that it would work with its federal partners  to discuss the development of a more formalized approach for addressing  the issues associated with the importation of unapproved drugs. However,  HHS questioned whether the framework should include an approach for  developing more reliable volume estimates, because HHS believes the  volume estimates already provided in HHS’s December 2004 report on  drug importation are valid. HHS said that volume may depend on the  incentive for the public to import unapproved drugs, as well as other  external factors, and said that, short of opening and counting each  package as it enters the United States, the reliability of estimates would  always be in question given the fluid nature of unapproved prescription  drug imports and the number of mail and courier facilities involved. HHS  also stated that volume estimates would not alter the resource calculations  articulated in HHS’s December 2004 report, which, according to HHS,  were derived from special operations, called blitzes, by CBP and FDA at  various international mail facilities. According to HHS, these calculations  were based on personnel time and salaries needed to process each  package. HHS further noted that our statement that the task force agencies  could develop statistically valid volume estimates and realistic risk-based  estimates of the number of staff needed to interdict parcels at mail  facilities did not recognize that FDA is not always able to process the  current number of packages set aside by CBP. In addition, HHS said that  FDA must always be cognizant of competing priorities regardless of  fluctuations in the volume of illegally imported prescription drugs.
We recognize that any number of factors can influence the volume of  unapproved drugs entering the country at any point in time or location.  However, HHS’s current estimates are based on estimates of drugs  imported from Canada during 2003 and, in part, on extrapolations from  FDA’s limited observations during special operations at international mail  branch facilities. We believe a more reliable and systematic approach  might begin by using information already being collected by CBP and FDA  at the various field locations, including the number of packages deemed  abandoned by CBP and the number of imported packages FDA handles.  With regard to resource calculations, as more reliable estimates are  developed, FDA and other task force agencies would be better positioned  to define the scope of the problem so that the task force and other  decision makers can make informed choices about resources devoted to  this problem, especially in light of competing priorities.
Regarding our recommendation that the HHS Secretary assess FDA’s  statutorily required notification process, HHS said that it intends to pursue  an updated assessment. HHS observed that, given the increased volume of  illegally imported prescription drugs since its initial request for  modification of FDA’s notification process, other actions might be needed,  and HHS would work with its federal partners to determine the actions  required. HHS also provided technical comments that have been included,  as appropriate.
USPS did not state whether it agreed or disagreed with our  recommendations but expressed a concern about possible procedural and  legislative changes to the current notification requirements governing the  processing and disposition of imported pharmaceuticals. Specifically,  USPS requested that the report acknowledge the United States’s  international postal obligations and stated that any discussion of options  to expedite the processing and disposition of prescription drugs should  consider these obligations. USPS further noted that recognizing these  obligations is particularly important with respect to registered or insured  mail for which the Postal Service can be held financially responsible if it is  not delivered or returned. We acknowledge USPS’s concerns and have  added language to the report accordingly.
As arranged with your offices, unless you publicly announce its contents  earlier, we plan no further distribution of this report until 30 days after its  issue date. At that time, we will send copies of this report to the Secretary  of the Department of Homeland Security, the Secretary of Health and  Human Services, and interested congressional committees. We will also  make copies available to others upon request. In addition, the report will  be available at no charge on GAO’s Web site at http://www.gao.gov.
If you or your staff have any questions concerning this report, please  contact me on (202) 512-8777 or stanar@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on the  last page of this report. Major contributors to this report are listed in  appendix IX.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: This report addresses the following questions: (1) What do available data  show about the volume and safety of prescription drugs imported into the  United States for personal use through the international mail and private  carriers? (2) What procedures and practices are used at selected facilities  to inspect and interdict prescription drugs unapproved for import?   (3) What factors affect federal agency efforts to enforce the prohibition on  prescription drug importation for personal use through international mail  and carrier facilities? (4) What efforts have federal agencies undertaken to  coordinate the enforcement of the prohibitions on personal importation of  prescription drugs?
We performed our work at the Department of Homeland Security’s U.S.  Customs and Border Protection (CBP) and U.S. Immigration and Customs  Enforcement (ICE), the Department of Health and Human Services’ (HHS)  Food and Drug Administration (FDA), the Department of Justice’s Drug  Enforcement Administration (DEA), the U.S. Postal Service (USPS), and  the Office of National Drug Control Policy (ONDCP). We also carried out  work at 3 of the 14 international mail facilities—New York, Los Angeles,  and Chicago—and 2 of the 29 carrier facilities—Cincinnati (DHL  Corporation) and Memphis (FedEx Corporation). We selected the New  York and Los Angeles mail facilities because they (1) processed among the  highest overall number of packages, representing 27 percent of the total  number of estimated packages going through international mail facilities  in 2002 and (2) also received prescription drugs. The Chicago facility was  selected because it received prescription drugs and provided geographic  dispersion. The 2 carrier facilities selected were (1) different companies;  (2) handled the highest overall number of packages, according to data  provided by CBP; and (3) were located near each other. At each of these  locations, we collected and reviewed available relevant importation and  interdiction data from FDA and CBP; observed inspection and interdiction  practices; met with CBP and FDA management, inspectors, and  investigators to discuss issues related to inspection and pharmaceutical  importation volume; and reviewed relevant documents on inspection and  interdiction procedures. At the international mail facilities, we also met  with USPS officials to discuss mail handling and processing procedures.  The information from our site visits is limited to the 3 international mail  facilities and 2 carrier facilities and is not generalizable to the remaining 10  international mail facilities and 27 carrier facilities.
To determine what the available data show about the volume and safety of  imported prescription drugs, we interviewed CBP, FDA, DEA, ICE, and  USPS headquarters officials and CBP and FDA officials at the 3  international mail facilities and 2 carrier facilities. We obtained and  analyzed available data on the volume and safety of imported prescription  drugs (1) collected from the facilities we visited and (2) gathered through  multiagency special operations at selected mail facilities and provided to  us by CBP headquarters. The available CBP and FDA information on the  volume and safety of prescription drugs imported through the mail and  carrier facilities we visited was primarily based on estimates and limited to  observations at these locations. To obtain additional views on the overall  volume or safety of imported prescription drugs, we reviewed ONDCP and  HHS reports and testimony from the American Medical Association. We  discussed with FDA officials the methodology used to develop the volume  estimates presented in the 2004 HHS report on prescription drug  importation and we reviewed the methodology to determine any  limitations. In addition, we interviewed an official and reviewed  documents from the National Association of Boards of Pharmacy to obtain  the association’s findings on the safety of prescription drugs imported  from foreign-based Internet pharmacies. We also relied on existing GAO  work on the safety of prescription drugs imported from some foreign- based Internet pharmacies.
To understand procedures and practices, we reviewed current federal law  and CBP and FDA policies, procedures, and guidance regarding or  applicable to prescription drugs and controlled substance importation. We  interviewed officials at CBP, FDA, DEA, ICE, and USPS headquarters. To  understand inspection procedures and practice, at each of 3 international  mail facilities and 2 carrier facilities, we carried out site visits, observing  the inspection process and interviewing CBP and FDA officials. At the  selected international mail facilities, we also interviewed USPS officials to  obtain information about their procedures and practices. In addition, when  FDA and CBP implemented new procedures at the international mail  facilities and carrier facilities, we carried out additional interviews at FDA  and CBP headquarters, pursued telephone interviews with CBP and FDA  officials at the facilities we had visited, and revisited 2 of the mail facilities  to determine how the new procedures were being implemented, working  in practice; and being monitored and evaluated. We also obtained from  FDA fiscal year data on the number of mail packages containing  prescription drugs it processed. From CBP we obtained data on the  number of packages interdicted using its new procedures for processing  schedule III through V controlled substances. Because these data were  used for contextual purposes, we did not assess the reliability of these  data. However, we discussed the scope of the FDA and CBP data with the  respective agency officials and have noted the limitations in the report.
To determine what factors affect federal agency efforts to enforce the  prohibitions on prescription drug importation for personal use through  international mail and carrier facilities, we interviewed CBP, FDA, DEA,  ICE, and USPS officials. We asked these officials to identify any factors  that affected their respective agency’s efforts to process or interdict  prescription drugs imported through the mail and carriers. The  information presented in this report is limited to the views expressed by  the officials interviewed. In addition, we met with representatives from  MasterCard International and Visa U.S.A., Inc., the two credit card  associations identified by DEA as the organizations used by the majority of  Internet drug sites. These associations also testified in July 2004 at  congressional hearings on matters related to the illegal importation of  prescription drugs. We discussed with them each association’s efforts to  assist federal enforcement of the prohibitions on prescription drug  importation.
To determine what efforts federal agencies have undertaken to coordinate  the enforcement of the prohibitions on personal importation of  prescription drugs, we interviewed CBP, USPS, FDA, DEA, ICE, and  ONDCP headquarters officials. We obtained and reviewed documents  describing these initiatives, their status, and any studies or data describing  the results of the initiatives. These documents included agency guidelines  and memorandums, indicating changes to agency policies and procedures;  congressional hearings; and selected legislative proposals. We obtained  these documents from agency officials; agency Web sites, as directed by  agency officials; and congressional Web sites. We also interviewed CBP  and FDA field officials at the selected international mail facilities and  private carrier facilities to ascertain the status of the implementation of  these initiatives. We analyzed and synthesized the information gathered  from the interviews and documents.
In addition, in appendix III of this report, we used data from FDA on the  number of open and closed investigations it had undertaken related to  Internet drug sales and imported prescription drugs. We also used data  from DEA on the number of arrests related to the illegal diversion of  pharmaceuticals. Because these data were used for contextual purposes,  we did not assess their reliability.
We conducted our review between April 2004 and August 2005 in  accordance with generally accepted government auditing standards.
section_title: Appendix II: General Description of the Controlled Substance Schedules I through V
paragraphs: The drugs and drug products that come under the Controlled Substances  Act are divided into five schedules. A general description and examples of  the substances in each schedule are outlined below.
section_title: Appendix III: Federal Agencies Work with Credit Card Organizations to Enforce Prohibitions on Prescription Drugs
paragraphs: During congressional hearings in July 2004, representatives from  MasterCard International and Visa U.S.A., Inc., testified on issues  concerning the use of credit cards to purchase prescription drugs for  importation from Internet pharmacies, including discussions with federal  law enforcement agencies to address these issues. Accordingly, we met  with Drug Enforcement Administration (DEA), Food and Drug  Administration (FDA), and Immigration and Customs Enforcement (ICE)  officials, as well as representatives from MasterCard International and  Visa U.S.A., Inc. to more fully understand how these organizations are  working together to address prohibitions on prescription drug  importation. The agency officials and credit card association  representatives described their working relationship as cooperative, but  complicated by legal and practical considerations. The following section  summarizes our discussions.
subsections: section_title: Investigations of Credit Card Purchases of Prescription Drugs Imported from Internet Pharmacies Can Be Complicated by Legal and Practical Considerations
paragraphs: According to FDA, DEA, and ICE officials, their agencies have worked  with credit card organizations to obtain information to investigate the  importation of prescription drugs purchased with a credit card from  Internet pharmacies, but these investigations were complicated by legal  and practical considerations. Such considerations included privacy laws;  federal law enforcement agencies’ respective subpoena authority,  priorities, and jurisdictions; and the ease with which merchants engaged in  illegal activity can enter into a new contract with a different bank to use  the same payment system. In addition, according to the two credit card  associations we contacted, their respective associations have also  undertaken searches of the Internet for Web sites that appeared to be  selling problematic materials and accepting their respective payment  cards, but these investigations can also be complicated by legal  considerations.
Privacy laws can sometimes limit the extent to which companies,  including credit card organizations, will provide information to federal law  enforcement agencies about parties to a transaction. FDA and DEA  officials told us that credit card organizations and/or banks and other  financial institutions, when they have the direct contractual relationship  with the merchants, have provided to the agencies information regarding  transactions involving prescription drugs prohibited from import, as well  as alerting federal officials when suspicious activity is detected. However,  they said that the companies do not provide information about the parties  involved in the transaction without a subpoena. Representatives from the  two associations with whom we met explained that law enforcement  usually needs to issue a subpoena because of company concerns about  possible legal action by the subject of the investigation (for example, if the  subject asserted that information was provided by the association or bank  to law enforcement in violation of federal privacy laws). They further  noted, however, that their respective associations would provide law  enforcement information without a subpoena, when properly requested  under certain circumstances, including matters of national security or  when a human life was in immediate jeopardy.
DEA, ICE, and FDA officials confirmed that they are able to obtain  information from credit card companies and/or banks and other financial  institutions through subpoenas, although the agencies have different  subpoena authority with regard to entities, such as banks and credit card  companies. DEA and ICE have the authority to subpoena information  directly from such entities, but FDA must ask a U.S. Attorney to obtain a  grand jury subpoena requesting the information. DEA and ICE may also  use grand jury subpoenas. For example, DEA officials told us that usually  they are able to obtain needed information using administrative  subpoenas; however, they may use a grand jury subpoena if a company  will not provide the requested information or a U.S. Attorney prefers that  approach. DEA, FDA, and ICE could not readily provide data on the  number of subpoenas served because (1) data on DEA and ICE  administrative subpoenas were maintained at the field office requesting  the subpoena and were not organized according to payment method and  (2) none of the agencies could share grand jury information.
Agencies’ priorities also affect their ability to conduct investigations of  credit card purchases of prescription drugs for importation. According to  FDA, DEA, and ICE officials, their investigations, including those involving  imported prescription drugs, focused on commercial quantities, rather  than quantities to be consumed for personal use. DEA officials also said  that DEA seeks to dismantle major drug supply and money laundering  organizations; therefore, its investigations of prescription drug violations  focused on the suppliers of Internet pharmacies, not individual consumers.  DEA reported no active cases on individuals who were illegally importing  controlled substance pharmaceuticals over the Internet for personal  consumption. FDA, DEA, and ICE officials said that investigations  involving smaller quantities may be handled by state and local law  enforcement.
In addition to the quantity of drugs being imported, federal enforcement  agencies consider jurisdiction when determining whether to pursue an  investigation, including investigations of Internet pharmacies using credit  card payment systems that cross U.S. borders. For a federal enforcement  agency to determine whether it has jurisdiction to investigate potential  illegal activity outside the United States, it generally needs to consider  whether (1) the federal statute or statutes violated apply to activity outside  the country and (2) there is sufficient evidence of an intent to produce  effects in the United States or some other connection to the United States,  such as a U.S. distributor. Pursuit of investigations of Internet pharmacies  using credit card payment systems presents both jurisdictional and  practical limitations, when some or all of the operations (e.g., pharmacies,  Web sites, and bank accounts) are located in foreign countries and there is  no U.S. distributor. According to FDA officials, in cases that FDA does not  have jurisdiction to pursue, it may ask its foreign counterparts for  assistance. ICE officials told us that they focused on transporters of  commercial quantities across U.S. borders from a foreign country into the  United States.
By contrast, DEA enforces a statute that specifically applies to  manufacturers or distributors of certain prescription drugs who are  located in foreign countries. Specifically, DEA has jurisdiction over a  manufacturer or distributor of schedule II controlled substances in a  foreign country who knows or intends that such substances will be  unlawfully imported into the United States. However, the relevant statute  does not apply to prescription drugs that are schedules III through V  controlled substances. Therefore, according to a DEA official, to pursue  such investigations, DEA has to devise other ways to reach those  operating outside the United States.
A DEA official said that another practical consideration affecting  investigations of credit card purchases of imported prescription drugs was  the ease with which merchants engaged in illegal activities were able to  open new merchant credit card accounts. Credit card association  representatives confirmed that the reappearance of the same violators  using a different name or bank, or even disguising the illegal activity as a  different and legal activity, can be a problem. They said that unlike law  enforcement, credit card organizations do not have the authority to arrest  the violators, and some of the merchants engaged in such illegal activities  are skilled at moving from bank to bank and masking their illegal  activities.
In addition to investigations by federal law enforcement agencies, each of  the credit card associations we contacted had also undertaken searches of  the Internet for Web sites that appeared to be selling problematic  materials and using its payment cards. One association used a vendor to  carry out the searches and then provided the information to its member  banks regarding their merchants who appear to have been involved in  selling controlled substances. The other association’s security personnel  conducted the Internet search, identified the sites, and then attempted to  contact the member bank that had contracted with the merchant.  Representatives of the latter association told us that as a result of this  effort, at the association’s request, contracts with approximately 500  merchants had been terminated by the member banks that had authorized  the particular merchants to accept the association’s credit card.
Representatives from both associations agreed that federal law  enforcement agencies were in the best position to enforce the prohibition  on prescription drug importation, because they have arrest authority and  can remove the violators. However, these representatives had differing  opinions concerning the desirability of their taking any additional  enforcement steps in this area. Representatives of one association told us  they did not want the authority to make purchases to confirm that illegal  transactions were occurring. They said once their investigators identified a  site willing to sell drugs, they contacted the bank that authorized the  merchant’s account so that the bank could take appropriate action.   Further, they told us that the association was not set up to make such  purchases safely and its mail room was not structured to take delivery.   Representatives of the other association told us that their association  would like the authority to make such purchases, noting that their  investigations were complicated by the inability of the association’s  security personnel to purchase controlled substances. However, these  representatives told us that, if they were allowed to make such  transactions, they would expect to turn over the controlled substances to  federal law enforcement immediately upon receipt.
A DEA official told us that currently credit card organizations are not  exempt from the general prohibition against possessing controlled  substances, and therefore it is illegal for them to purchase controlled  substances from an Internet pharmacy to show that the pharmacy is acting  illegally. He also said that even if the law were changed to allow such  transactions, executing them could be unmanageable, because the  companies would have to comply with federal regulations for handling and  storing controlled substances. For example, federal regulations require  that controlled substances be stored in a safe, vault, steel cabinet, or cage.  The regulations also specify the methods and materials to be used to  construct the storage facility, as well as the type of security system  (alarms, locks, and anti-radiation devices) required to prevent entry. Even  if a credit card company planned to turn over purchased controlled  substances to federal law enforcement upon receipt, it would need to have  a facility as prescribed by federal regulations to hold and store the  substances until a DEA agent could take possession of them.
section_title: Federal Enforcement Agencies and Credit Card Associations Have Discussed Credit Card Enforcement Issues
paragraphs: Federal enforcement agencies and credit card organizations have had  periodic discussions about credit card enforcement issues involving  purchases of prescription drugs for importation from Internet pharmacies.  In addition, the associations told us that they had provided information  about this issue to banks and other financial institutions.
According to FDA and DEA officials and representatives of the two credit  card associations we contacted, meetings have been held periodically,  between individual agencies (e.g., DEA and FDA) or as part of the  Customs and Border Protection (CBP) Interagency Task Force (discussed  earlier in this report) and with representatives of one or more companies  present. Association representatives told us that they believed that the  meetings, which began in late 2003, have provided an educational  opportunity for both the credit card companies and the federal law  enforcement agencies. For example, the representatives of one association  said that during the meetings they had described how the association’s  payment system operated, explaining (1) the relationship among the  association, the banks and other financial institutions, merchants, and  cardholders, and (2) which entities maintained the transactional  information needed by law enforcement for investigations of Internet  pharmacies. They said that DEA and FDA had explained federal laws  related to the importation of prescription drugs, both controlled and  noncontrolled substances. Representatives of the other association said  that the meetings helped to educate its officials about issues, concerns,  and risks related to the illegal importation of prescription drugs. In  addition, agency officials and association representatives said that they  had discussed the role credit card organizations can play with regard to  illegal importation. No minutes of these meetings are maintained.
According to association representatives, information obtained at these  meetings was disseminated to the banks and other financial institutions  through bulletins. Through association bulletins, both credit card  associations provided to banks and other financial institutions information  concerning the illegal importation of prescription drugs. The bulletins  reminded the recipients of their obligation to ensure that the credit card  system was not to be used for illegal activity, alerted them to the risk of  illegal activity involving transactions for prescription medications  purchased over the Internet, and underscored the need for due diligence  to ensure that merchants were not engaged in illegal activities. One  association also issued a press release that, according to the association’s  representatives, was to communicate to the public information similar to  that which had been sent to the banks.
FDA and DEA officials and association representatives said that the  dialogue was continuing and described the relationship between the  agencies and associations as good. A meeting between credit card  organizations and the CBP task force is to be held in late summer 2005.  Moreover, they noted that informal contacts between the agencies and the  credit card organizations occurred, as needed, on specific matters related  to prescription drug importation. However, agency officials confirmed that  they had no plan or written strategy for dealing with credit card  organizations related to the illegal importation of prescription drugs  purchased with a credit card.
section_title: Appendix IV: Comments from the Department of Homeland Security
section_title: Appendix V: Comments from the Department of Justice, Drug Enforcement Administration
section_title: Appendix VI: Comments from the Department of Health and Human Services
section_title: Appendix VII: Comments from the Office of National Drug Control Policy
section_title: Appendix VIII: Comments from the U.S. Postal Service
section_title: Appendix IX: GAO Contact and Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: In addition to the above, John F. Mortin, Assistant Director; Leo M.  Barbour; Frances A. Cook; Katherine M. Davis; Michele C. Fejfar; Yelena T.  Harden; James R. Russell; and Barbara A. Stolz made key contributions to  this report.