Prescription Drugs:

Strategic Framework Would Promote Accountability and Enhance Efforts to Enforce the Prohibitions on Personal Importation

GAO-05-372: Published: Sep 8, 2005. Publicly Released: Nov 10, 2005.

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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.

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.

Status Legend:

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  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Homeland Security: Directorate of Border and Transportation Security: Bureau of Customs and Border Protection

    Status: Closed - Not Implemented

    Comments: In fiscal year 2005, we analyzed how Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) work with other federal agencies at international mail and express carrier facilities to inspect for and interdict prescription drugs illegally imported for personal use. We reported, among other things, that neither CBP nor FDA systematically collected data on the volume or safety of these imports and recommended that CBP work with the other federal agencies to develop an approach for estimating the scope of the problem. CBP provided a study, completed in fiscal year 2007, that estimates the volume of controlled substances and non-controlled prescription drugs shipped via international mail, through U.S. Postal Service International Mail Branches, to the United States. This study did not fully address our recommendation because CBP did not provide (1) complete information on methodology, including information on how the estimates were derived (based on a statistically valid sample and how the time period for study was chosen); (2) whether the estimates included controlled substances mailed as prescription drugs (drugs defined by the Drug Enforcement Administration as category III, IV, and V controlled substances, such as Valium or Tylenol with codeine, rather than category I or II--drugs such as heroin, marijuana, or kaat), (3) estimates on controlled substances or prescription drugs entering the country via express carriers, such as FEDEX or UPS; and plans for doing the study during future periods to examine trends. By putting in place a means to consistently assess the scope of the drug importation problem, CBP and other agencies would be better able to make informed decisions about strategies moving forward, prioritize activities, and ensure that resources are focused on the areas of greatest need. In July 2009, CBP officials reported that no additional action had been taken with regard to (1) obtaining data on the volume of drugs entering the country, including via express carriers and (2) establishing a strategic framework to assess the problem; developing a strategic framework for moving forward; prioritize activities; and take steps to ensure that resources can be focused on areas of greatest need. Therefore, we are closing this recommendation as not implemented.

    Recommendation: In view of the FDA's continuing concern about the statutory notification requirement and its impact on enforcement, the Secretary of HHS should assess the ramifications of removing or modifying the requirement, report on the results of this assessment, and, if appropriate, recommend changes to Congress.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Not Implemented

    Comments: In fiscal year 2005, we analyzed how Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) work with other federal agencies at international mail and express carrier facilities to inspect for and interdict prescription drugs illegally imported for personal use. We reported, among other things, that the FDA has said it faces a significant challenge handling the substantial volume of prescription drugs imported for personal use entering international mail facilities. Specifically, 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 be automatically refused. In September 2008, FDA officials indicated that the last actions taken on this recommendation appear to be from 2006 and that they do not anticipate being able to provide additional information about the status of this recommendation before fiscal year 2009. As of July 24, 2009, FDA officials had not provided any additional information about actions to address this recommendation.

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