Volume of Prescription Drug Imports Is Unknown but Believed to Be Substantial, and the Safety of These Drug Imports Is Not Assured

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. 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. For example, a CBP official recently testified that the agency  did not have data on the total number of packages containing imported  controlled substances. 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. The procedures outline how FDA personnel are to  prioritize packages for inspection, inspect the packages, and make  admissibility determinations. Factors beyond Inspection and Interdiction Complicate Efforts to Enforce the Prohibitions on Personal Importation of Prescription Drugs

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. 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. Federal Efforts to Coordinate Law Enforcement Activities Could Benefit from a Strategic Framework

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. They said that their  proposal has yet to be finalized with CBP. 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. 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. 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. (2) What procedures and practices are used at selected facilities  to inspect and interdict prescription drugs unapproved for import? 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.
Why GAO Did This Study

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.

What GAO Found

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.